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Precision Allograft Cartilage Kit (PACK™)

FDA UDI

Class I (US FDA UDI)

by Rti Surgical, Inc.

Identity

Trade Name
Precision Allograft Cartilage Kit (PACK™) FDA UDI
Generic Name
General internal orthopaedic fixation system implantation kit FDA UDI
Device Name
PACK Ring Guide, 20mm FDA UDI
Model / Reference
PAC-A2020 FDA UDI
Description
PACK Ring Guide, 20mm FDA UDI

Identifiers

Catalog Number
PAC-A2020 FDA UDI
Primary DI / UDI-DI
00191083047034 FDA UDI
FDA Product Code
FZX FDA UDI
GMDN Term
General internal orthopaedic fixation system implantation kit 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

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: General internal orthopaedic fixation system implantation kit

Precision Allograft Cartilage Kit (PACK™) by Rti Surgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General internal orthopaedic fixation system implantation kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rti Surgical, Inc.

Sources (1)

  • FDA UDI 8eec12d7-1c08-4e61-95be-42d73d7851ff 35 fields · synced Jun 1, 2026