Identity
- Trade Name
- Poly-Tape 20 mm x 800 mm FDA UDI
- Generic Name
- Polyester suture, non-bioabsorbable, multifilament FDA UDI
- Model / Reference
- 102-1082 FDA UDI
Identifiers
- Catalog Number
- 102-1082 FDA UDI
- Primary DI / UDI-DI
- 05060267132536 FDA UDI
- FDA Product Code
- OWX FDA UDIFTL FDA UDIQUW FDA UDI
- GMDN Term
- Polyester suture, non-bioabsorbable, multifilament FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Polyester suture, non-bioabsorbable, multifilament
The Poly-Tape 20 mm x 800 mm is a high-quality, non-bioabsorbable polyester suture used for soft-tissue wound closure in orthopedics and general plastic surgery. This single-use device features a multifilament design that provides temporary support until the wound heals, making it ideal for delicate procedures or where antimicrobial properties are required.
Similar devices
Also classified as Polyester suture, non-bioabsorbable, multifilament.
- WEGO-Polyester Nonabsorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II
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- DemeBOND — DemeTECH Corp · Class II
- DEKNATEL — TELEFLEX INCORPORATED · Class II
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- DEKNATEL — TELEFLEX INCORPORATED · Class II
Cleared under the same submission
K220091 also covers:
K222978 also covers:
- AchilloCordPLUS — XIROS LTD
- Infinity-Lock 3 — XIROS LTD
- Infinity-Lock 3 — XIROS LTD
- Infinity-Lock 5 — XIROS LTD
- Infinity-Lock 5 — XIROS LTD
- Infinity-Lock 7 — XIROS LTD
- Poly-Tape 10 mm x 800 mm — XIROS LTD
- Poly-Tape 15 mm x 800 mm — XIROS LTD
- Poly-Tape 30mm x 800mm — XIROS LTD
- Poly-Tape 5 mm x 500 mm — XIROS LTD
- Poly-Tape 5 mm x 800 mm — XIROS LTD
- Poly-Tape 7 mm x 800 mm — XIROS LTD
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Xiros Ltd
Sources (1)
- FDA UDI da647f93-6029-4124-b148-fc11fe1d7c69 35 fields · synced Jul 18, 2026