AccessGUDID - DEVICE: Graftgun Universal Graft Delivery System

GUDID

Device Identifier (DI) Information

Brand Name: Graftgun Universal Graft Delivery System - Cartridge Kit
Version or Model: IG-K-1000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SURGENTEC, LLC

Primary DI Number: 00858406007433
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004095409 *Terms of Use

Device Description: Graftgun Universal Graft Delivery System - Cartridge Kit labeled with new catalog number for distribution by Integrity Implants

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:	Yes
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?
35809	Orthopaedic cement dispenser	A syringe-like device intended for use in placing orthopaedic bone cement into surgical sites. Cement dispensers may be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, Piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180937	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: 8dee7599-eecd-4449-8dad-ec751537172a
Public Version Date: December 05, 2019
Public Version Number: 1
DI Record Publish Date: November 27, 2019