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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
Surgical implant template, single-use FDA UDI
Device Name
17 mm x 28 mm MACI Cutter FDA UDI
Model / Reference
82031 FDA UDI
Description
17 mm x 28 mm MACI Cutter FDA UDI

Identifiers

Catalog Number
N/A FDA UDI
Primary DI / UDI-DI
00860004093091 FDA UDI
FDA Product Code
FZT FDA UDI
GMDN Term
Surgical implant template, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

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: Surgical implant template, 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 Surgical implant template, 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 0319a4eb-251c-4f11-9e78-800045ffd5a9 34 fields · synced May 30, 2026