FDA.reportPublic FDA data

Instrument

Primary DI
07613327354034
Brand
Instrument
Company
Howmedica Osteonics Corp.
Model
I-U0257GR28
Catalog number
I-U0257GR28
Device description
Specialty ReUnion RSA Glenoid Reamer
Published
2017-05-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327354034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327354034076133273540347613327354034

GMDN Terms#

Term, Definition table
TermDefinition
Glenoid orthopaedic reamerAn orthopaedic surgical instrument designed to cut and resurface with precision the glenoid fossa for the acceptance of the glenoid fossa component of a shoulder joint prosthesis. The device is designed with a hemispherical head with an abrasive/cutting outer surface attached to a shaft for connection to a manual or powered handle. It is typically made of a high-grade stainless steel alloy and is available in various sizes. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
058311945
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327259797INSTRUMENT1100-2800R1100-2800R2016-09-24
07613327138078SOLAR5351-41085351-41082015-09-24
04546540167415EXETER0942-2-1100942-2-1102015-09-24
04546540167422EXETER0942-2-1120942-2-1122015-09-24
04546540167439EXETER0942-2-1140942-2-1142015-09-24
04546540167446EXETER0942-2-1160942-2-1162015-09-24
04546540167453EXETER0942-2-1180942-2-1182015-09-24
04546540167460EXETER0942-2-1200942-2-1202015-09-24
07613327245158INSTRUMENT6543-4-8186543-4-8182017-11-13
07613327660180Instrument5533-T-409-R5533-T-409-R2026-02-27
07613327648386Instrument5533-T-812-R5533-T-812-R2026-02-26
07613327648393Instrument5533-T-811-L5533-T-811-L2026-02-26
07613327648409Instrument5533-T-812-L5533-T-812-L2026-02-26
07613327648416Instrument5533-T-810-R5533-T-810-R2026-02-26
07613327648423Instrument5533-T-816-L5533-T-816-L2026-02-26
07613327648430Instrument5533-T-809-L5533-T-809-L2026-02-26
07613327648447Instrument5533-T-814-R5533-T-814-R2026-02-26
07613327648454Instrument5533-T-809-R5533-T-809-R2026-02-26
07613327648461Instrument5533-T-810-L5533-T-810-L2026-02-26
07613327648478Instrument5533-T-811-R5533-T-811-R2026-02-26

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Primary DI, Brand, Company table
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