698327138

GUDID 10705034314716

MODIFIED INSTRUMENT ILIAC CUTTER ASSEMBLY 7.25mm

DEPUY SPINE, LLC

Bone trephine, reusable
Primary Device ID10705034314716
NIH Device Record Key151853c7-7262-454c-879b-d803b8401bc9
Commercial Distribution StatusIn Commercial Distribution
Version Model Number698327138
Catalog Number698327138
Company DUNS107105876
Company NameDEPUY SPINE, LLC
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110705034314716 [Primary]

FDA Product Code

HWKTREPHINE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10705034314716]

Moist Heat or Steam Sterilization


[10705034314716]

Moist Heat or Steam Sterilization


[10705034314716]

Moist Heat or Steam Sterilization


[10705034314716]

Moist Heat or Steam Sterilization


[10705034314716]

Moist Heat or Steam Sterilization


[10705034314716]

Moist Heat or Steam Sterilization


[10705034314716]

Moist Heat or Steam Sterilization


[10705034314716]

Moist Heat or Steam Sterilization


[10705034314716]

Moist Heat or Steam Sterilization


[10705034314716]

Moist Heat or Steam Sterilization


[10705034314716]

Moist Heat or Steam Sterilization


[10705034314716]

Moist Heat or Steam Sterilization


[10705034314716]

Moist Heat or Steam Sterilization


[10705034314716]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-04-03
Device Publish Date2018-06-05

Devices Manufactured by DEPUY SPINE, LLC

10705034575964 - N/A2024-08-12 MODIFIED INSTRUMENT DRIVER X 25
10705034576787 - N/A2024-08-12 MODIFIED INSTRUMENT BLADE HOLDER HANDLE
10705034576800 - N/A2024-08-12 MODIFIED INSTRUMENT BLADE HOLDER ARM MOUNT
10705034581231 - N/A2024-08-12 MODIFIED INSTRUMENT CAMERA ADAPTER
10705034576640 - N/A2024-07-31 MODIFIED INSTRUMENT CURETTE
10705034576671 - N/A2024-07-31 MODIFIED INSTRUMENT RASP SHEATH
10705034576695 - N/A2024-07-31 MODIFIED INSTRUMENT INSERTER SMALL HANDLE T27
10705034576701 - N/A2024-07-31 MODIFIED INSTRUMENT INSERTER T27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.