AccessGUDID - DEVICE: Precision Allograft Cartilage Kit (PACK™) (00191083046822)

GUDID

Device Identifier (DI) Information

Brand Name: Precision Allograft Cartilage Kit (PACK™)
Version or Model: PAC-A1124
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PAC-A1124
Company Name: Rti Surgical, Inc.

Primary DI Number: 00191083046822
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117560455 *Terms of Use

Device Description: PACK TAMP, 24MM

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
32873	Surgical tamp, reusable	A hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXG	TAMP

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e4f67925-34a1-4dee-9396-2bd365b6d2b7
Public Version Date: October 22, 2024
Public Version Number: 1
DI Record Publish Date: October 14, 2024