Washer, Concave

FDA UDI

Class II (US FDA UDI)

by I.T.S. GmbH

Identity

Trade Name: Washer, Concave FDA UDI
Generic Name: Implantable bone washer FDA UDI
Device Name: Washer, Flat, AD=15,0mm, ID=7,5mm FDA UDI
Model / Reference: 36732 FDA UDI
Description: Washer, Flat, AD=15,0mm, ID=7,5mm FDA UDI

Identifiers

Catalog Number: 36732 FDA UDI
Primary DI / UDI-DI: 09120034308451 FDA UDI
FDA Product Code: HTN FDA UDI
GMDN Term: Implantable bone washer 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Implantable bone washer

Washer, Concave by I.T.S. GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Implantable bone washer.

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Monster Screw System — Paragon 28 · Class II
FLAT WASHER — Biomet Orthopedics, Inc. · Class II
Fixcet Spinal Facet Screw System — Xtant Medical Holdings, Inc. · U
LEOS Cannulated Screw System — Tyber Medical · Class II

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: I.T.S. GmbH

Sources (1)

FDA UDI 0e432501-03e2-470d-b391-d8dfcc9d80e9 34 fields · synced Jun 8, 2026