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MACI Arthroscopic Instruments

FDA UDI

Class I (US FDA UDI)

by Vericel Corporation

Identity

Trade Name
MACI Arthroscopic Instruments FDA UDI
Generic Name
Orthopaedic graft inserter, single-use FDA UDI
Device Name
MACI Applicators, Two-Pack FDA UDI
Model / Reference
82039 FDA UDI
Description
MACI Applicators, Two-Pack FDA UDI

Identifiers

Catalog Number
N/A FDA UDI
Primary DI / UDI-DI
10850037506009 FDA UDI
FDA Product Code
HXG FDA UDI
GMDN Term
Orthopaedic graft inserter, single-use 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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: Orthopaedic graft inserter, single-use

MACI Arthroscopic Instruments by Vericel Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic graft inserter, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vericel Corporation

Sources (1)

  • FDA UDI 4bcec48b-9007-49f4-9384-5001f1bfce82 34 fields · synced May 31, 2026