Steel Wire

FDA UDI

Class II (US FDA UDI)

by Resorba Medical GmbH

Identity

Trade Name: STEEL WIRE FDA UDI
Generic Name: Metallic suture, monofilament FDA UDI
Model / Reference: STEEL WIRE FDA UDI

Identifiers

Primary DI / UDI-DI: E203USL99065 FDA UDI
510(k) Number: K143582 FDA UDI
FDA Product Code: GAQ FDA UDI
GMDN Term: Metallic suture, monofilament FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4495 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

Category: Metallic suture, monofilament

Steel Wire by Resorba Medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Metallic suture, monofilament.

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Myo/Wire II — A & E MEDICAL CORPORATION · Class II
ACIER — PETERS SURGICAL · Class II
Myo/Wire II — A & E MEDICAL CORPORATION · Class II
Myo/Wire II — A & E MEDICAL CORPORATION · Class II

Cleared under the same submission

K143582 also covers:

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: Resorba Medical GmbH

Sources (1)

FDA UDI 70c68428-9a38-4a3a-8bbe-fe6a917a0778 33 fields · synced May 30, 2026