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SportsMed Instruments

FDA UDI

Class I (US FDA UDI)

by Medacta International

Identity

Trade Name
SportsMed Instruments FDA UDI
Generic Name
Arthroscopic surgical procedure kit, medicated FDA UDI
Device Name
Acorn Reamer Ø 9 L195 - STERILE FDA UDI
Model / Reference
05.05.10.0161 FDA UDI
Description
Acorn Reamer Ø 9 L195 - STERILE FDA UDI

Identifiers

Primary DI / UDI-DI
07630345748218 FDA UDI
FDA Product Code
NBH FDA UDI
GMDN Term
Arthroscopic surgical procedure kit, medicated FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.1100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Arthroscopic surgical procedure kit, medicated

SportsMed Instruments by Medacta International — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Arthroscopic surgical procedure kit, medicated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medacta International

Sources (1)

  • FDA UDI e76f74b5-9904-4801-8e29-c7082262a3c5 33 fields · synced May 31, 2026