AccessGUDID - DEVICE: b-ONE™ Primary Acetabular System (00843575102454)

GUDID

Device Identifier (DI) Information

Brand Name: b-ONE™ Primary Acetabular System
Version or Model: 881201321H
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 881201321H
Company Name: B-ONE ORTHO, CORP.

Primary DI Number: 00843575102454
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081315444 *Terms of Use

Device Description: Acetabular Liner, Hooded, 10 degree; Vitamin E UHMWPE; 32mm Inner Diameter, Size H

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?
43168	Non-constrained polyethylene acetabular liner	A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
HWC	Screw, Fixation, Bone
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: f9a2bced-0bc8-46df-8901-0301a529311b
Public Version Date: March 19, 2019
Public Version Number: 1
DI Record Publish Date: March 11, 2019