Identity
- Trade Name
- Poly-Tape 30mm x 800mm FDA UDI
- Generic Name
- Surgical support tape, non-bioabsorbable FDA UDI
- Model / Reference
- 102-1083 FDA UDI
Identifiers
- Catalog Number
- n/a FDA UDI
- Primary DI / UDI-DI
- 05060267131812 FDA UDI
- FDA Product Code
- FTL FDA UDIOWX FDA UDIQUW FDA UDIJDR FDA UDI
- GMDN Term
- Surgical support tape, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Polyester suture, non-bioabsorbable, multifilamentSurgical support tape, non-bioabsorbable
Poly-Tape 30mm x 800mm by Xiros Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical support tape, non-bioabsorbable.
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Cleared under the same submission
K010051 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 20 mm x 800 mm — 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
United States Pending data
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 e466786a-63ff-487a-939a-a230eabb0ab2 35 fields · synced May 30, 2026