Summary for ARTG Entry:
The Critical Group Pty Ltd - Quill Monoderm Knotless Tissue-Closure Device (PGA-PCL) - Suture,
ARTG entry for
Medical Device Included Class III
The Critical Group Pty Ltd
PO Box 6466,BAULKHAM HILLS BUSINESS CENTRE, NSW, 2153
ARTG Start Date
Medical Device Class III
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Angiotech Puerto Rico Inc
Road 459 KM 0.6 Montana Industrial Park
Aguadilla, , 00603
1. Quill Monoderm Knotless Tissue-Closure Device (PGA-PCL) - Suture, poliglecaprone
Single Device Product
45814 Suture, poliglecaprone
The Quill Monoderm knotless tissue closure device is a synthetic absorbable monofilament suture
prepared from a co-polymer of glycolide and e-caprolactone. The device consists of barbed suture material
armed with a surgical needle on each end. The barbs allow for tissue approximation without the need to tie
The Quill Monoderm sutures are indicated for use in soft tissue approximation where the use of
absorbable sutures is appropriate.
Length (cm) 36 x 36 (Barb Length)
Length (cm) 40 x 40 (Barb Length)
Length (cm) 45 x 45 (Barb Length)
Shape (of tip) Taper 1/2 Circle
Length (mm) 12-70
Shape (of tip) Cutting - Straight
Shape (of tip) Reverse Cutter - 3/8 Circle
Shape (of tip) Reverse Cutter - 1/2 Circle
Shape (of tip) Diamond 3/8 Circle
Length (cm) 30 x 30 (Barb Length)
Length (cm) 16 x 16 (Barb Length)
Length (cm) 14 x 14 (Barb Length)
Length (cm) 7 x 7 (Barb Length)
Length (cm) 3.5 x 3.5 (Barb Length)
Shape (of tip) Diamond 1/2 Circle
Suture, gauge 0 - 3.0 USP Diameter
No Specific Conditions included on Record
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