AccessGUDID - DEVICE: B-P TOTAL HIP SYSTEM (00814193023018)

GUDID

Device Identifier (DI) Information

Brand Name: B-P TOTAL HIP SYSTEM
Version or Model: 01-03-0038
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 01-03-0038
Company Name: ENDOTEC, INC.

Primary DI Number: 00814193023018
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 FEMORAL RESURFACING CUP W/BIOCOAT & W/ULTRACOAT - 38 MM

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?
33717	Resurfacing metallic hip prosthesis	An implantable partial substitute for a disease-damaged hip joint intended to replace the articulating surfaces of the hip while preserving the natural femoral head and neck. It consists of a metallic femoral cap component, that is placed over (resurfaces) a surgically-prepared femoral head, and a metallic acetabular component; that is, both components are supplied together. Fixation devices for implantation (e.g., screws/bolts) may be included and implantation may be performed with or without bone cement. This device is commonly used for younger/active patients to avoid total hip replacements/revisions.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KXA	Prosthesis, Hip, Femoral, Resurfacing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K904870	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
Outer Diameter: 38 Millimeter

Device Record Status

Public Device Record Key: 08925f87-7376-4ee7-a289-a4f062ae25e3
Public Version Date: April 17, 2024
Public Version Number: 7
DI Record Publish Date: September 17, 2015