FDA.report

SMR Shoulder

Primary DI
08033390155878
Brand
SMR Shoulder
Company
LIMACORPORATE SPA
Model
9013.04.018
Catalog number
9013.04.018
Device description
SMR Shoulder - Trial Finned Short Stem Dia.18 mm
Published
2019-12-04
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08033390155878PrimaryGS10

GMDN Terms

TermDefinition
Humeral stem prosthesis trialA copy of a final humeral stem prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
432066322
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
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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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
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08033390202619PRIMA1367.09.3061367.09.3062026-02-19

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