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Poly-Tape 15 mm x 800 mm

FDA UDI

Class II (US FDA UDI)

by Xiros Ltd

Identity

Trade Name
Poly-Tape 15 mm x 800 mm FDA UDI
Generic Name
Polyester suture, non-bioabsorbable, multifilament FDA UDI
Model / Reference
102-1081 FDA UDI

Identifiers

Catalog Number
n/a FDA UDI
Primary DI / UDI-DI
05060267130488 FDA UDI
510(k) Number
K010051 FDA UDI
FDA Product Code
JDR FDA UDI
GMDN Term
Polyester suture, non-bioabsorbable, multifilament FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 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
MRI Safety
MR Conditional FDA UDI

Category: Polyester suture, non-bioabsorbable, multifilament

Poly-Tape 15 mm x 800 mm by Xiros Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyester suture, non-bioabsorbable, multifilament.

Cleared under the same submission

K010051 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Xiros Ltd

Sources (1)

  • FDA UDI 283da836-bf64-491b-92c9-0bc768159de8 35 fields · synced Jun 8, 2026