Summary for ARTG Entry:
Johnson & Johnson Medical Pty Ltd - Stratafix Spiral PDO (Polydioxanone) Knotless Tissue Control Device
- Unidirectional - Suture, polydioxanone
ARTG entry for
Medical Device Included Class III
Johnson & Johnson Medical Pty Ltd
PO Box 134,NORTH RYDE BC, NSW, 1670
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. Stratafix Spiral PDO (Polydioxanone) Knotless Tissue Control Device - Unidirectional - Suture,
Single Device Product
16584 Suture, polydioxanone
Stratafix Spiral PDO Knotless Tissue Contol Device is an absorbable, unidirectional barbed monofilament
suture armed with a surgical needle at one end, and a Variable Loop Design at the opposite end to
preclude the use of a knot to secure tissue.
Stratafix Spiral PDO (Polydioxanone) Knotless Tissue Control Device is indicated for use in soft tissue
approximation where the use of absorbable sutures is appropriate.
Suture, needle, physical attributes Length (mm): 19
Suture, needle, physical attributes Precision Point
Suture, needle, physical attributes Taper point
Suture, needle, physical attributes 3/8 circle
Suture, needle, physical attributes 1/2 circle
Suture, gauge 2 to 3.5 metric
Length (cm) 20 to 45
No Specific Conditions included on Record
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