AccessGUDID - DEVICE: Biocore9 Femoral Resurfacing Component (00810068850420)

GUDID

Device Identifier (DI) Information

Brand Name: Biocore9 Femoral Resurfacing Component
Version or Model: Femoral Resurfacing Component - 45.5 mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01-03-0045
Company Name: Biocore9, LLC

Primary DI Number: 00810068850420
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 093081548 *Terms of Use

Device Description: Biocore9 Femoral Resurfacing Head Component 45.5 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?
64683	Resurfacing metallic femoral head prosthesis	An implantable, metallic, partial substitute for a disease-damaged hip joint intended to replace the articulating surface of the femoral head while preserving the natural femoral head and neck. 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 [?]
K201219	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
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 45.5 Millimeter

Device Record Status

Public Device Record Key: 972e8a18-b4cb-4553-8b65-c2e533d05418
Public Version Date: October 05, 2021
Public Version Number: 1
DI Record Publish Date: September 27, 2021