FDA.report

R3 ACETABULAR

Primary DI
03596010597724
Brand
R3 ACETABULAR
Company
Smith & Nephew, Inc.
Model
71331948
Catalog number
71331948
Device description
R3 3 HOLE HA COATED ACETABULAR SHELL 48MM
Published
2020-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MBLProsthesis, hip, semi-constrained, uncemented, metal/polymer, porous

Product Code Classifications

CodeDeviceSpecialtyClass
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03596010597724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03596010597724035960105977243596010597724

GMDN Terms

TermDefinition
Acetabular shellAn implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
045483575
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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