TFN-ADVANCE 04038010S

GUDID H67904038010S0

TI END CAP FOR TFNA 10MM EXTN - STERILE

SYNTHES (U.S.A.) LP

Bone nail end-cap
Primary Device IDH67904038010S0
NIH Device Record Keyc62b1287-519a-4a6c-aa71-74c35568878c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTFN-ADVANCE
Version Model Number04.038.010S
Catalog Number04038010S
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
GS110886982098368 [Primary]
HIBCCH67904038010S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


[H67904038010S0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-04-07
Device Publish Date2015-09-14

On-Brand Devices [TFN-ADVANCE]

H67904038015S0TI END CAP FOR TFNA 15MM EXTN - STERILE
H67904038010S0TI END CAP FOR TFNA 10MM EXTN - STERILE
H67904038005S0TI END CAP FOR TFNA 5MM EXTN - STERILE
H67904038000S0TI END CAP FOR TFNA 0MM EXTN - STERILE

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.