Pitch-Patch 30 mm x 20 mm

FDA UDIFDA 510(k)

Class II (US FDA UDI)

510(k) K211563

by Xiros Ltd

Identity

Trade Name: Pitch-Patch 30 mm x 20 mm FDA UDI
Generic Name: Surgical support tape, non-bioabsorbable FDA UDI
Model / Reference: 102-1090 FDA UDI

Identifiers

Catalog Number: 102-1090 FDA UDI
Primary DI / UDI-DI: 05060267133755 FDA UDI
510(k) Number: K230671 FDA UDI
FDA Product Code: OWX FDA UDI
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 — 30 Millimeter FDA UDI
Width — 20 Millimeter FDA UDI

Category: Surgical support tape, non-bioabsorbable

Pitch-Patch 30 mm x 20 mm by Xiros Ltd — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Similar devices

Also classified as Surgical support tape, non-bioabsorbable.

Axiom® Lig-A-Loops® — AXIOM MEDICAL, INCORPORATED · Class I
Axiom® Lig-A-Loops® — AXIOM MEDICAL, INCORPORATED · Class I
Bard® PTFE Braided Tape — Bard Peripheral Vascular · Class II
Arthrex® — Arthrex, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class II
Devon — Cardinalhealth · Class II

Cleared under the same submission

K230671 also covers:

Pitch-Patch 35 mm x 25 mm — XIROS LTD

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K211563	Class II	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Xiros Ltd
FDA Applicant: Xiros, Ltd.

Sources (2)

FDA UDI 61298bfc-303f-4688-b1ba-1d164f0d7781 60 fields · synced Jun 18, 2026
FDA 510(k) K211563 1 fields · synced May 25, 2026