Pitch-Patch 35 mm x 25 mm

FDA UDI

Class II (US FDA UDI)

by Xiros Ltd

Identity

Trade Name: Pitch-Patch 35 mm x 25 mm FDA UDI
Generic Name: Surgical support tape, non-bioabsorbable FDA UDI
Model / Reference: 102-1091 FDA UDI

Identifiers

Catalog Number: 102-1091 FDA UDI
Primary DI / UDI-DI: 05060267132024 FDA UDI
510(k) Number: K211563 FDA UDI
FDA Product Code: FTL FDA UDI
GMDN Term: Surgical support tape, non-bioabsorbable 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Length — 35 Millimeter FDA UDI
Width — 25 Millimeter FDA UDI

Category: Surgical support tape, non-bioabsorbable

Pitch-Patch 35 mm x 25 mm 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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Arthrex® — Arthrex, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class II
Devon — Cardinalhealth · Class II

Cleared under the same submission

K211563 also covers:

Pitch-Patch 30 mm x 20 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 6369ca02-adb3-4ac2-bbe5-186314e6478a 36 fields · synced Jun 8, 2026