FDA.report

SMR Shoulder

Primary DI
08033390095303
Brand
SMR Shoulder
Company
LIMACORPORATE SPA
Model
TT Metal Back Press
Catalog number
9013.75.390
Device description
TT Metal Back Press
Published
2016-04-12
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

Product Codes

CodeName
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Product Code Classifications

CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08033390095303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08033390095303080333900953038033390095303

GMDN Terms

TermDefinition
Orthopaedic implant/instrument assembling deviceA non-sterile, noninvasive tool designed to support assembly of the component parts of an orthopaedic implant or surgical instrument during an orthopaedic surgical procedure, typically when component sizes are determined during the procedure [e.g., stem, neck, and head femoral components of a total hip arthroplasty (THA)]. It is available in one of a variety of forms (e.g., holder, clamp/press), however it is not a component of the final instrument/implant and is not a surgical screwdriver or wrench. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
432066322
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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08033390050036SMR System1362.09.1201362.09.1202026-02-19
08033390191135PRIMA1367.09.3761367.09.3762026-02-19
08033390201971PRIMA1367.09.2001367.09.2002026-02-19
08033390202299PRIMA1367.09.2031367.09.2032026-02-19
08033390202305PRIMA1367.09.2061367.09.2062026-02-19
08033390202312PRIMA1367.09.2701367.09.2702026-02-19
08033390202466PRIMA1367.09.2731367.09.2732026-02-19
08033390202473PRIMA1367.09.2761367.09.2762026-02-19
08033390202480PRIMA1367.09.4031367.09.4032026-02-19
08033390202497PRIMA1367.09.4061367.09.4062026-02-19
08033390202503PRIMA1367.09.3001367.09.3002026-02-19
08033390202602PRIMA1367.09.3031367.09.3032026-02-19
08033390202619PRIMA1367.09.3061367.09.3062026-02-19

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10885862657541EquinoxeExactech, Inc.KWS2025-09-09
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