FDA.report

b-ONE™ Primary Acetabular System

Primary DI
00843575103406
Brand
b-ONE™ Primary Acetabular System
Company
B-ONE ORTHO, CORP.
Model
881906032G
Catalog number
881906032G
Device description
ACETABULAR LINER TRIAL, NEUTRAL, 0 degree, SIZE G X 32MM I.D.
Published
2019-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HWTTemplate

Product Code Classifications

CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00843575103406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00843575103406008435751034068435751034060843575103406

GMDN Terms

TermDefinition
Acetabulum prosthesis trial, reusableA copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
081315444
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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