03816620S

GUDID 07612334173324

BONE SCREW FOR BLADE FIXATION STERILE

SYNTHES (U.S.A.) LP

Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable
Primary Device ID07612334173324
NIH Device Record Keyafee4cef-403f-4959-a38c-91b37e7e2d6b
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.816.620S
Catalog Number03816620S
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS107612334173324 [Direct Marking]
GS107612334173324 [Direct Marking]
GS107612334173324 [Direct Marking]
GS107612334173324 [Direct Marking]
GS107612334173324 [Direct Marking]
GS107612334173324 [Direct Marking]
GS107612334173324 [Direct Marking]
GS107612334173324 [Direct Marking]
GS110705034821917 [Primary]
GS110705034821917 [Primary]
GS110705034821917 [Primary]
GS110705034821917 [Primary]
GS110705034821917 [Primary]
GS110705034821917 [Primary]
GS110705034821917 [Primary]
GS110705034821917 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

Devices Manufactured by SYNTHES (U.S.A.) LP

07612334216298 - NA2020-11-09 STYLET Ø 4 MM
07612334216168 - NA2020-11-09 4TH BLADE CURVED NARROW SHORT
07612334216175 - NA2020-11-09 4TH BLADE CURVED NARROW MED
07612334216182 - NA2020-11-09 4TH BLADE CURVED NARROW LONG
07612334216199 - NA2020-11-09 4TH BLADE CURVED WIDE SHORT
07612334216205 - NA2020-11-09 4TH BLADE CURVED WIDE MEDIUM
07612334216212 - NA2020-11-09 4TH BLADE CURVED WIDE LONG
07612334216267 - NA2020-11-09 4TH BLADE STRAIGHT SHORT

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