02127156TS

GUDID 10886982307200

3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/56MM

SYNTHES (U.S.A.) LP

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)
Primary Device ID10886982307200
NIH Device Record Keyb3fe1cb4-4303-4592-a55b-61303afd9454
Commercial Distribution StatusIn Commercial Distribution
Version Model Number02.127.156TS
Catalog Number02127156TS
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
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 Datetrue
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
GS110886982307200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

[10886982307200]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-09
Device Publish Date2021-04-01

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H981042006160 - Axon2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 32MM THREAD LENGTH
H981042006170 - Axon2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 34MM THREAD LENGTH
H981042006180 - Axon2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 36MM THREAD LENGTH
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