AccessGUDID - DEVICE: TRI-LOCK GRIPTION (10603295001072)

GUDID

Device Identifier (DI) Information

Brand Name: TRI-LOCK GRIPTION
Version or Model: 1012-14-050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 101214050
Company Name: DEPUY ORTHOPAEDICS, INC.

Primary DI Number: 10603295001072
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080506581 *Terms of Use

Device Description: TRI-LOCK BPS FEMORAL STEM 12/14 TAPER TRI-LOCK BPS W/GRIPTION SIZE 5 HI 105mm

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?
33581	Coated hip femur prosthesis, modular	A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MRA	Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

FDA Premarket Submission

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

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: c783bff6-0100-42f7-b10c-b6556614e74f
Public Version Date: December 13, 2024
Public Version Number: 7
DI Record Publish Date: March 24, 2015