FDA.report

HOFFMANN

Primary DI
07613252610298
Brand
HOFFMANN
Company
Stryker Trauma SA
Model
4933-1-011
Catalog number
4933-1-011
Device description
Connecting Nut - Long LRF M8 x 15mm
Published
2016-09-22
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
true

Related Records

Product Codes

CodeName
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Product Code Classifications

CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613252610298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613252610298076132526102987613252610298

GMDN Terms

TermDefinition
Orthopaedic bone nutA sterile profiled block made of metallic or non-metallic material that is threaded on its inside surface, and designed to securely fasten a bone fixation bolt, possibly with a washer. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
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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