202738

GUDID H6792027380

3.0MM CANNULATED SCREW LONG THREAD/38MM

Synthes GmbH

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device IDH6792027380
NIH Device Record Keyd0d7d05e-0775-43e4-9021-13d527c3f526
Commercial Distribution StatusIn Commercial Distribution
Version Model Number202.738
Catalog Number202738
Company DUNS486711679
Company NameSynthes GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
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
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982144676 [Primary]
HIBCCH6792027380 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTNWASHER, BOLT NUT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


[H6792027380]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-29
Device Publish Date2015-09-14

Devices Manufactured by Synthes GmbH

10886982350039 - NA2025-08-15 CRE DRILL GUIDE 15MM
10886982350046 - NA2025-08-15 CRE DRILL GUIDE 18MM
10886982350053 - NA2025-08-15 CRE DRILL GUIDE 20MM
10886982350060 - NA2025-08-15 CRE DRILL GUIDE 25MM
10886982350077 - NA2025-08-15 7.0MM CAN TAP LARGE QUICK COUPLING
07612334226747 - NA2025-07-31 LID 2/3 SIZE STAINLESS STEEL
07612334227980 - NA2025-07-31 TRAY FOR OPERACE, 1 FROM 2
07612334228352 - NA2025-07-31 TRAY FOR OPERACE, 2 FROM 2

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.