ZuriMED Technologies AG

FDA UDI

Class II (US FDA UDI)

by ZuriMED Technologies AG

Identity

Trade Name: ZuriMED Technologies AG FDA UDI
Generic Name: Surgical support tape, non-bioabsorbable FDA UDI
Device Name: ZuriMED Technologies AG - FiberLocker Instrument SN FDA UDI
Model / Reference: FL516SNA FDA UDI
Description: ZuriMED Technologies AG - FiberLocker Instrument SN FDA UDI

Identifiers

Primary DI / UDI-DI: 07649988202247 FDA UDI
510(k) Number: K241219 FDA UDI
FDA Product Code: OWX 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

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Surgical support tape, non-bioabsorbable

ZuriMED Technologies AG by ZuriMED Technologies AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical support tape, non-bioabsorbable.

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Bard® PTFE Braided Tape — Bard Peripheral Vascular · Class II
Arthrex® — Arthrex, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class II
Infinity-Lock 5 — XIROS LTD · Class II
Arthrex® — Arthrex, Inc. · Class II

Cleared under the same submission

K241219 also covers:

ZuriMED Technologies AG — ZuriMED Technologies AG

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: ZuriMED Technologies AG

Sources (1)

FDA UDI d0ef8dba-8434-4dfb-b525-c6be2d0d3596 34 fields · synced Jun 6, 2026