AccessGUDID - DEVICE: G7 PROVISIONAL MINI TRAY (00880304568570)

GUDID

Device Identifier (DI) Information

Brand Name: G7 PROVISIONAL MINI TRAY
Version or Model: 110010217
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 110010217
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00880304568570
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 129278169 *Terms of Use

Device Description: No description.

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?
44742	Joint prosthesis implantation kit, reusable	A collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OQH	Hip, semi-constrained, cemented, metal/polymer + additive, cemented
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
PBI	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
OQG	Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
OQI	Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121874	000

Device Exempt from Premarket Submission: No 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
Device Size Text, specify: G 28/32/36MM

Device Record Status

Public Device Record Key: 0d506a8f-d10a-44a0-b9ba-67d335879b5d
Public Version Date: May 30, 2025
Public Version Number: 4
DI Record Publish Date: October 28, 2016