FDA.report

Polarcup Impactor Interface Sz 51

Primary DI
09421028114936
Brand
Polarcup Impactor Interface Sz 51
Company
ENZTEC LIMITED
Model
351342512151
Catalog number
351342512151
Device description
A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
Published
2023-02-17
Public version status
New
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

Product Codes

CodeName
HWAImpactor

Product Code Classifications

CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09421028114936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09421028114936094210281149369421028114936

GMDN Terms

TermDefinition
Orthopaedic prosthesis implantation 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. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
592616445
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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09421038412152Offset coupling, Z/H9209-13069209-13062026-03-09
09421038412169Offset drive train, locking9209-13039209-13032026-03-09
09421038412176Short Offset Cover – United9209-13079209-13072026-03-09
09421038412183Handle – United9209-13059209-13052026-03-09
09421038412299Cup reamer handle, offset, AO, locking9209-13119209-13112026-03-09
09421038412305Offset coupling, AO9209-13139209-13132026-03-09
09421038412312Cup reamer handle, offset, AO, open9209-13129209-13122026-03-09
09421038412329Offset drive train, open9209-13049209-13042026-03-09
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09421038411896Adj Dist Fem Alignment Guide – Paddle4240-77014240-77012026-02-27
09421038411902Sagittal Alignment Connector - Pivot4240-77054240-77052026-02-27
09421038411919Sagittal Alignment Connector - Pivot with Fan4240-77064240-77062026-02-27
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09421038411940Dist Fem Cut Block Connector – 10mm4240-77124240-77122026-02-27
09421038411957Dist Fem Cut Block Slot Connector – 8mm4240-77254240-77252026-02-27

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