AccessGUDID - DEVICE: G7 POLY LINER REMOVAL SCREW (00880304566385)

GUDID

Device Identifier (DI) Information

Brand Name: G7 POLY LINER REMOVAL SCREW
Version or Model: 010002751
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 010002751
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00880304566385
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:	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?
36235	Manual surgical rotary handpiece, reusable	A manually-powered, hand-held, surgical device intended to be used to provide rotary motion for an endpiece (not included) during a surgical procedure such as cutting, sculpting, trepanning, or drilling bone and driving Kirschner wires; it is not dedicated to a specific clinical procedure. It is available in two main designs: 1) a U-shaped drill brace powered by the surgeon who holds the top of the brace steady whilst rotating it with horizontal crankshaft-like movements; or 2) a drill powered by the rotation of a side-mounted handle, and which may be cannulated to allow for use of a guidewire. Both types may have a Jacobs chuck or collet to hold the drill bit. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PBI	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
OQI	Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
OQH	Hip, semi-constrained, cemented, metal/polymer + additive, cemented
OQG	Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
LWZ	TISSUE GRAFT OF LESS THAN 6MM
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121874	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: 6e577e91-87df-4b83-99ad-9fbd3f6b4b2e
Public Version Date: May 30, 2025
Public Version Number: 7
DI Record Publish Date: September 23, 2016