AccessGUDID - DEVICE: RANAWAT / BURSTEIN HIP SYSTEM (00880304193130)

GUDID

Device Identifier (DI) Information

Brand Name: RANAWAT / BURSTEIN HIP SYSTEM
Version or Model: 105854
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 105854
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00880304193130
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?
46138	Ureteral catheter holder	A small, sterile device with a locking mechanism designed to secure a ureteral catheter to ensure that it remains in place when inserted into the ureter; typically types that are indwelling. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K921277	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
Device Size Text, specify: 54MM REAM Ø 28MM INNER Ø

Device Record Status

Public Device Record Key: 3b70d054-213e-47bf-9152-11012294cbec
Public Version Date: May 30, 2025
Public Version Number: 4
DI Record Publish Date: October 24, 2015