FDA.report

SIGMA

Primary DI
10603295225768
Brand
SIGMA
Company
DEPUY INTERNATIONAL LTD
Model
9505-01-273
Catalog number
950501273
Device description
SIGMA HIGH PERFORMANCE CLASSIC ROTATION GUIDE 0 DEG
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HWTTEMPLATE

Product Code Classifications

CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10603295225768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1060329522576810603295225768

GMDN Terms

TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags

DUNS number
896498813
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

Other Devices From This Company

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10603295182313NA66671666712018-09-24
10603295225263LCS9505-01-2199505012192018-09-24
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10603295240501CHARNLEY9620-01-0009620010002018-09-24
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10603295241898CHARNLEY9623-00-0009623000002015-09-24
10603295241904CHARNLEY9623-01-0009623010002015-09-24
10603295242208CHARNLEY9623-40-0009623400002015-09-24
10603295242246CHARNLEY9623-43-0009623430002015-09-24
10603295242307CHARNLEY9623-47-0009623470002015-09-24
10603295242321CHARNLEY9623-49-0009623490002015-09-24
10603295242338CHARNLEY9623-50-0009623500002015-09-24
10603295065647DURALOC1599-23-0481599230482015-09-24
10603295065654DURALOC1599-23-0521599230522015-09-24
10603295065661DURALOC1599-23-0541599230542015-09-24
10603295065678DURALOC1599-23-0581599230582015-09-24
10603295065685DURALOC1599-23-0621599230622015-09-24
10603295235958C-STEM9612-21-0009612210002015-09-24

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