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SMR Shoulder

FDA UDI

Class I (US FDA UDI)

by Limacorporate

Identity

Trade Name
SMR Shoulder FDA UDI
Generic Name
Surgical drill guide, reusable FDA UDI
Device Name
Guide for Dia. 3,5 mm Drill FDA UDI
Model / Reference
9013.75.404 FDA UDI
Description
Guide for Dia. 3,5 mm Drill FDA UDI

Identifiers

Catalog Number
9013.75.404 FDA UDI
Primary DI / UDI-DI
08033390171519 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Surgical drill guide, 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical drill guide, reusable

SMR Shoulder by Limacorporate — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical drill guide, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Limacorporate

Sources (1)

  • FDA UDI a12e7fc0-68de-4f2a-9a5d-4c5d87721a8f 34 fields · synced Jun 8, 2026