AccessGUDID - DEVICE: B-P TOTAL HIP SYSTEM (00814193022653)

GUDID

Device Identifier (DI) Information

Brand Name: B-P TOTAL HIP SYSTEM
Version or Model: 01-01-0562
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 01-01-0562
Company Name: ENDOTEC, INC.

Primary DI Number: 00814193022653
Issuing Agency: GS1
Commercial Distribution End Date: March 04, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 803488357 *Terms of Use

Device Description: B-P HIP ACETABULAR FIXATION CUP W/BIOCOAT & W/ULTRACOAT - 62 MM 5 HOLE

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?
33715	Ceramic-on-polyethylene total hip prosthesis	A sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a ceramic-on-polyethylene or cross-linked polyethylene (PE) interface. 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
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K963101	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
Storage Environment Temperature: between 5 and 40 Degrees Celsius
Handling Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 5 HOLE
Outer Diameter: 62 Millimeter

Device Record Status

Public Device Record Key: 7efd9c44-f2d8-417d-88c5-cfe7502c0181
Public Version Date: April 11, 2024
Public Version Number: 6
DI Record Publish Date: September 17, 2015