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Fixit

FDA UDI

Class I (US FDA UDI)

by S.b.m

Identity

Trade Name
FIXIT FDA UDI
Generic Name
Arthroscopic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
Surgical Instrument Set consisting of reusable surgical instruments intended to be used during arthroscopic implantation of the FIXIT implant for rotator cuff repair (1st row). FDA UDI
Model / Reference
Complete FIXIT basket 1st FDA UDI
Description
Surgical Instrument Set consisting of reusable surgical instruments intended to be used during arthroscopic implantation of the FIXIT implant for rotator cuff repair (1st row). FDA UDI

Identifiers

Catalog Number
EPA9000001 FDA UDI
Primary DI / UDI-DI
03760154003384 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Arthroscopic surgical procedure kit, non-medicated, 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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Arthroscopic surgical procedure kit, non-medicated, reusable

Fixit by S.b.m — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Arthroscopic surgical procedure kit, non-medicated, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
S.b.m

Sources (1)

  • FDA UDI a71dfcf5-9c41-45a4-b5fb-9f4f573597b8 34 fields · synced Jun 8, 2026