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OSI200 Implant template

FDA UDI

Class I (US FDA UDI)

by Cochlear

Identity

Trade Name
OSI200 Implant template FDA UDI
Generic Name
Surgical implant template, single-use FDA UDI
Device Name
N/A FDA UDI
Model / Reference
P1291019 FDA UDI
Description
N/A FDA UDI

Identifiers

Catalog Number
P1291019 FDA UDI
Primary DI / UDI-DI
09321502043700 FDA UDI
FDA Product Code
LRC FDA UDI
GMDN Term
Surgical implant template, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical implant template, single-use

OSI200 Implant template by Cochlear — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical implant template, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cochlear

Sources (1)

  • FDA UDI eef8cd89-e46a-48b6-bf86-9db0af98d537 35 fields · synced Jun 1, 2026