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SMR Shoulder

FDA UDI

Class II (US FDA UDI)

by Limacorporate

Identity

Trade Name
SMR Shoulder FDA UDI
Generic Name
Surgical drill guide, reusable FDA UDI
Device Name
Glenoid Drilling Guide FDA UDI
Model / Reference
Drill Guide FDA UDI
Description
Glenoid Drilling Guide FDA UDI

Identifiers

Catalog Number
9CC0.13.009 FDA UDI
Primary DI / UDI-DI
08033390126694 FDA UDI
510(k) Number
K100858 FDA UDI
FDA Product Code
HSD FDA UDI
KWT FDA UDI
GMDN Term
Surgical drill guide, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3690 FDA UDI
888.3650 FDA UDI
Commercial Distribution
Not 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

No

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

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

Cleared under the same submission

K100858 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Limacorporate

Sources (1)

  • FDA UDI 659f0ba9-4671-47b8-9718-2edb83fc9483 36 fields · synced May 30, 2026