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SMR Shoulder

FDA UDI

Class II (US FDA UDI)

by Limacorporate

Identity

Trade Name
SMR Shoulder FDA UDI
Generic Name
Fluted surgical drill bit, reusable FDA UDI
Device Name
SMR Shoulder - Initial Glenoid Drill FDA UDI
Model / Reference
9013.75.121 FDA UDI
Description
SMR Shoulder - Initial Glenoid Drill FDA UDI

Identifiers

Catalog Number
9013.75.121 FDA UDI
Primary DI / UDI-DI
08033390167222 FDA UDI
FDA Product Code
KWT FDA UDI
KWS FDA UDI
MBF FDA UDI
PHX FDA UDI
GMDN Term
Fluted surgical drill bit, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3650 FDA UDI
888.3660 FDA UDI
888.3670 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

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

Category: Fluted surgical drill bit, reusable

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

Similar devices

Also classified as Fluted surgical drill bit, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Limacorporate

Sources (1)

  • FDA UDI b44f540b-9505-443c-a9fb-ecf75be6301c 34 fields · synced Jun 8, 2026