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S-Rom

FDA UDI

Class I (US FDA UDI)

by Depuy International Ltd

Identity

Trade Name
S-ROM FDA UDI
Generic Name
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Device Name
S-ROM A STEM IMPACTOR/INSERTER FDA UDI
Model / Reference
9005-98-210 FDA UDI
Description
S-ROM A STEM IMPACTOR/INSERTER FDA UDI

Identifiers

Catalog Number
900598210 FDA UDI
Primary DI / UDI-DI
10603295219712 FDA UDI
FDA Product Code
HWA FDA UDI
GMDN Term
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic inorganic implant inserter/extractor, reusable

S-Rom by Depuy International Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Depuy International Ltd

Sources (1)

  • FDA UDI d39873f5-ec22-4a65-a85b-a3c20890ee69 35 fields · synced May 30, 2026