SD03010530

GUDID 10886982347466

RIGID INSERTION SLEEVE

Synthes GmbH

Orthopaedic implantation sleeve, reusable
Primary Device ID10886982347466
NIH Device Record Keyf8330495-abe2-46c2-99b7-b47616cfb17e
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSD03.010.530
Catalog NumberSD03010530
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982347466 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDSNAIL, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10886982347466]

Moist Heat or Steam Sterilization


[10886982347466]

Moist Heat or Steam Sterilization


[10886982347466]

Moist Heat or Steam Sterilization


[10886982347466]

Moist Heat or Steam Sterilization


[10886982347466]

Moist Heat or Steam Sterilization


[10886982347466]

Moist Heat or Steam Sterilization


[10886982347466]

Moist Heat or Steam Sterilization


[10886982347466]

Moist Heat or Steam Sterilization


[10886982347466]

Moist Heat or Steam Sterilization


[10886982347466]

Moist Heat or Steam Sterilization


[10886982347466]

Moist Heat or Steam Sterilization


[10886982347466]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-02
Device Publish Date2024-07-25

Devices Manufactured by Synthes GmbH

10886982348982 - NA2025-07-24 Ø12.8MM HOLLOW REAMER
10886982349835 - NA2025-07-24 WRENCH / 11MM SLOTTED SOCKET
10886982350121 - NA2025-07-24 FEMORAL GONIOMETER
10886982350152 - NA2025-07-24 5TH MET WIRE GUIDE
10886982350428 - NA2025-07-24 TENS BENDING EXTRACTOR
10886982348326 - NA2025-07-08 SCREW RACK 3.0 & 4.0
10887587078434 - NA2025-07-03 REDUCTION FORCEPS W/ POINTS
10886982343994 - NA2025-07-01 Ø14MM HOLLOW REAMER - FRN

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