FDA.report

GAMMA

Primary DI
07613154985760
Brand
GAMMA
Company
Stryker Trauma GmbH
Model
1320-5320
Catalog number
1320-5320
Device description
Distal Targeting Device Gamma3 Distal Targeting R2.0
Published
2016-09-24
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
false

Related Records

Product Codes

CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Product Code Classifications

CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613154985760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613154985760076131549857607613154985760

GMDN Terms

TermDefinition
Orthopaedic implant aiming armA surgical jig-like device designed as a precision guide for the pre-drilling of orthopaedic screw holes into bone and for guiding an orthopaedic instrument into an implanted device, typically to treat long bones (e.g., femur, humerus, and tibia). It typically consists of two parts in one-piece or modular configurations: 1) an insertion guide in which the correctly angled/placed guide holes are situated; and 2) an insertion handle which will attach to the bone or implant. Drill guides or other drilling/tapping devices will be fed through the insertion guide at the precise intended angle, and it may have adaptations for providing magnetic alignment. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
330211587
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

Other Devices From This Company

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07613327376210T2 ALPHA2351-0390S2351-0390S2023-12-13
07613327361797T2 ALPHA2351-3080S2351-3080S2023-05-25
07613327361803T2 ALPHA2351-3100S2351-3100S2023-05-25
07613327406153T2 ALPHA2351-3082S2351-3082S2023-05-25
07613327406184T2 ALPHA2351-3102S2351-3102S2023-05-25
07613327095548T21806-14201806-14202022-04-27
07613153179443T21896-50551896-50552022-01-31
04546540202475T21896-50351896-50352022-01-27
07613153179368T21896-50251896-50252022-01-27
07613153179375T21896-50301896-50302022-01-27
07613153179399T21896-50401896-50402022-01-27
07613153179412T21896-50451896-50452022-01-27
07613153179436T21896-50501896-50502022-01-27
07613153179467T21896-50601896-50602022-01-27
07613153179474T21896-50651896-50652022-01-27
07613153179481T21896-50701896-50702022-01-27
07613153179498T21896-50751896-50752022-01-27
07613153179504T21896-50801896-50802022-01-27
07613153179511T21896-50851896-50852022-01-27
07613153179528T21896-50901896-50902022-01-27

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