FDA.report

TEMA Elbow

Primary DI
08033390126441
Brand
TEMA Elbow
Company
LIMACORPORATE SPA
Model
1552.14.020
Catalog number
1552.14.020
Device description
Ulnar Body large left
Published
2023-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
JDBProsthesis, Elbow, Semi-Constrained, Cemented

Product Code Classifications

CodeDeviceSpecialtyClass
JDBProsthesis, Elbow, Semi-Constrained, CementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08033390126441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08033390126441080333901264418033390126441

GMDN Terms

TermDefinition
Metal-backed elbow ulna prosthesisA sterile implantable device designed to replace the proximal ulna as part of an elbow joint replacement. The device is typically comprised of metal-backed polyethylene (PE) and its stem is usually coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

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

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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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08033390126434TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390126458TEMA ElbowLIMACORPORATE SPAJDB2019-05-24