FDA.report

REUNION

Primary DI
07613327355437
Brand
REUNION
Company
Stryker Trauma SA
Model
5542-P-0048-A
Catalog number
5542-P-0048-A
Device description
X3 PEGGED GLENOID
Published
2022-11-15
Public version status
New
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
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Product Code Classifications

CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613327355437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613327355437076133273554377613327355437

GMDN Terms

TermDefinition
Western equine encephalitis (WEE) virus total antibody IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total antibodies to Western equine encephalitis (WEE) virus in a clinical specimen.

Sterilization Methods

Method

Regulatory Flags

DUNS number
481999654
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
true
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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07613327625011PANGEA542132S542132S2024-12-01
07613327625028PANGEA5421135421132024-12-01
07613327625035PANGEA5421865421862024-12-01

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