FDA.report

R3

Primary DI
03596010600714
Brand
R3
Company
Smith & Nephew, Inc.
Model
71369766
Catalog number
71369766
Device description
R3 36MM INNER DIAMETER CERAMIC ACETABULAR TRIAL LINER 66/68MM OUTER DIAMETER
Published
2015-04-30
Public version status
Update
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

Contact Domains

Product Codes

CodeName
MRAProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

Product Code Classifications

CodeDeviceSpecialtyClass
MRAProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or UncementedUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03596010600714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03596010600714035960106007143596010600714

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

Contacts

PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags

DUNS number
109903521
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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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