Positioning handle - M8x1 interface 75.70.057

GUDID 07630055304612

Positioning handle assembly accessory for offset cup impactor M8x1 interface

Incipio Devices SA

Orthopaedic implant impactor, reusable
Primary Device ID07630055304612
NIH Device Record Key262182a7-ee52-417b-99b3-b1bbfe5ea057
Commercial Distribution StatusIn Commercial Distribution
Brand NamePositioning handle - M8x1 interface
Version Model Number75.70.057
Catalog Number75.70.057
Company DUNS485098284
Company NameIncipio Devices SA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107630055304612 [Primary]

FDA Product Code

HWAImpactor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630055304612]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-19
Device Publish Date2024-02-09

Devices Manufactured by Incipio Devices SA

07630055307262 - Cup Reamer Size 422025-12-29 Acetabular Reamer
07630055307279 - Cup Reamer Size 442025-12-29 Acetabular Reamer
07630055307286 - Cup Reamer Size 462025-12-29 Acetabular Reamer
07630055307293 - Cup Reamer Size 482025-12-29 Acetabular Reamer
07630055307309 - Cup Reamer Size 502025-12-29 Acetabular Reamer
07630055307316 - Cup Reamer Size 522025-12-29 Acetabular Reamer
07630055307323 - Cup Reamer Size 542025-12-29 Acetabular Reamer
07630055307330 - Cup Reamer Size 562025-12-29 Acetabular Reamer

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