USS 04602135

GUDID 10705034821153

10.0MM TI DUAL CORE USS 35MM SIDE-OPENING SCREW F/6.0MM ROD

Synthes GmbH

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID10705034821153
NIH Device Record Keye8e34672-d3d5-4cbe-8967-a7ecd12c1ef9
Commercial Distribution StatusIn Commercial Distribution
Brand NameUSS
Version Model Number04.602.135
Catalog Number04602135
Company DUNS486711679
Company NameSynthes GmbH
Device Count1
DM Exempttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110705034821153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10705034821153]

Moist Heat or Steam Sterilization

[10705034821153]

Moist Heat or Steam Sterilization

[10705034821153]

Moist Heat or Steam Sterilization

[10705034821153]

Moist Heat or Steam Sterilization

[10705034821153]

Moist Heat or Steam Sterilization

[10705034821153]

Moist Heat or Steam Sterilization

[10705034821153]

Moist Heat or Steam Sterilization

[10705034821153]

Moist Heat or Steam Sterilization

[10705034821153]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-22
Device Publish Date2022-07-14

On-Brand Devices [USS]

H981046212750TI CLAMP FOR USS ILIAC CONNECTORS-FIXED LENGTH
H981046212700TI CLAMP FOR USS ILIAC CONNECTOR-TELESCOPIC
H981046211900TI COLLET FOR USS ILIAC AND S2 CONNECTORS
H981046211710TI USS ILIAC CONNECTOR 17MM-27MM TELESCOPIC
H981046211450TI USS ILIAC CONNECTOR 45MM FIXED LENGTH
H981046211420TI USS ILIAC CONNECTOR 42MM FIXED LENGTH
H981046211390TI USS ILIAC CONNECTOR 39MM FIXED LENGTH
H981046211360TI USS ILIAC CONNECTOR 36MM FIXED LENGTH
H981046211330TI USS ILIAC CONNECTOR 33MM FIXED LENGTH
H981046211300TI USS ILIAC CONNECTOR 30MM FIXED LENGTH
H981046211270TI USS ILIAC CONNECTOR 27MM FIXED LENGTH
H981046211240TI USS ILIAC CONNECTOR 24MM FIXED LENGTH
H981046211210TI USS ILIAC CONNECTOR 21MM FIXED LENGTH
H981046211180TI USS ILIAC CONNECTOR 18MM FIXED LENGTH
H981046211150TI USS ILIAC CONNECTOR 15MM FIXED LENGTH
H981046211120TI USS ILIAC CONNECTOR 12MM FIXED LENGTH
H9810460746909.0MM TI USS CANC POLYAXIAL SCREW 140MM THREAD LENGTH
H9810460746709.0MM TI USS CANC POLYAXIAL SCREW 130MM THREAD LENGTH
H9810460746509.0MM TI USS CANC POLYAXIAL SCREW 120MM THREAD LENGTH
H9810460746409.0MM TI USS CANC POLYAXIAL SCREW 110MM THREAD LENGTH
H9810460746309.0MM TI USS CANC POLYAXIAL SCREW 100MM THREAD LENGTH
H9810460746209.0MM TI USS CANC POLYAXIAL SCREW 90MM THREAD LENGTH
H9810460746109.0MM TI USS CANC POLYAXIAL SCREW 80MM THREAD LENGTH
H9810460746009.0MM TI USS CANC POLYAXIAL SCREW 70MM THREAD LENGTH
H9810460745909.0MM TI USS CANC POLYAXIAL SCREW 65MM THREAD LENGTH
H9810460745809.0MM TI USS CANC POLYAXIAL SCREW 60MM THREAD LENGTH
H9810460745709.0MM TI USS CANC POLYAXIAL SCREW 55MM THREAD LENGTH
H9810460745609.0MM TI USS CANC POLYAXIAL SCREW 50MM THREAD LENGTH
H9810460745509.0MM TI USS CANC POLYAXIAL SCREW 45MM THREAD LENGTH
H9810460745409.0MM TI USS CANC POLYAXIAL SCREW 40MM THREAD LENGTH
H9810460745309.0MM TI USS CANC POLYAXIAL SCREW 35MM THREAD LENGTH
H9810460745209.0MM TI USS CANC POLYAXIAL SCREW 30MM THREAD LENGTH
H981046074120TI COLLAR FOR 6.0MM RODS FOR USS POLYAXIAL
H981046074020TI POLYAXIAL HEAD FOR USS POLYAXIAL
H9810460728908.0MM TI USS CANC POLYAXIAL SCREW 140MM THREAD LENGTH
H9810460728708.0MM TI USS CANC POLYAXIAL SCREW 130MM THREAD LENGTH
H9810460728508.0MM TI USS CANC POLYAXIAL SCREW 120MM THREAD LENGTH
H9810460728408.0MM TI USS CANC POLYAXIAL SCREW 110MM THREAD LENGTH
H9810460728308.0MM TI USS CANC POLYAXIAL SCREW 100MM THREAD LENGTH
H9810460728208.0MM TI USS CANC POLYAXIAL SCREW 90MM THREAD LENGTH
H9810460728108.0MM TI USS CANC POLYAXIAL SCREW 80MM THREAD LENGTH
H9810460728008.0MM TI USS CANC POLYAXIAL SCREW 70MM THREAD LENGTH
H9810460727908.0MM TI USS CANC POLYAXIAL SCREW 65MM THREAD LENGTH
H9810460727808.0MM TI USS CANC POLYAXIAL SCREW 60MM THREAD LENGTH
H9810460727708.0MM TI USS CANC POLYAXIAL SCREW 55MM THREAD LENGTH
H9810460727608.0MM TI USS CANC POLYAXIAL SCREW 50MM THREAD LENGTH
H9810460727508.0MM TI USS CANC POLYAXIAL SCREW 45MM THREAD LENGTH
H9810460727408.0MM TI USS CANC POLYAXIAL SCREW 40MM THREAD LENGTH
H9810460727308.0MM TI USS CANC POLYAXIAL SCREW 35MM THREAD LENGTH
H9810460727208.0MM TI USS CANC POLYAXIAL SCREW 30MM THREAD LENGTH
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