ACF 396935

GUDID 07611819738720

ACF DETACHABLE TRIAL SPACER CONVEX 9MM

SYNTHES (U.S.A.) LP

Orthopaedic implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable
Primary Device ID07611819738720
NIH Device Record Keycc824865-7f17-4951-b42f-0d636cab0178
Commercial Distribution StatusIn Commercial Distribution
Brand NameACF
Version Model Number396.935
Catalog Number396935
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 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
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
GS107611819738720 [Direct Marking]
GS110705034778037 [Primary]
HIBCCH9813969350 [Secondary]

FDA Product Code

HWTTEMPLATE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


[07611819738720]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-04-06
Device Publish Date2019-08-10

On-Brand Devices [ACF]

07611819738607ACF DETACHABLE TRIAL SPACER LORDOTIC 8MM
07611819738584ACF DETACHABLE TRIAL SPACER LORDOTIC 6MM
07611819738577ACF DETACHABLE TRIAL SPACER LORDOTIC 5MM
07611819233911ACF TRIAL SPACER HANDLE
07611819738744ACF DETACHABLE TRIAL SPACER CONVEX 10MM
07611819738720ACF DETACHABLE TRIAL SPACER CONVEX 9MM
07611819738706ACF DETACHABLE TRIAL SPACER CONVEX 8MM
07611819738683ACF DETACHABLE TRIAL SPACER CONVEX 7MM
07611819738652ACF DETACHABLE TRIAL SPACER CONVEX 6MM
07611819738645ACF DETACHABLE TRIAL SPACER CONVEX 5MM
07611819738638ACF DETACHABLE TRIAL SPACER LORDOTIC 10MM
07611819738621ACF DETACHABLE TRIAL SPACER LORDOTIC 9MM
07611819978157IMPLANT HOLDER FOR ACF ALLOGRAFT SPACERS
H9813963840ACF SPACER IMPLANT HOLDER
H9813890780SPN CORRECTION ACF EXTENDED IMPLANT HOLDER
H9813890770SPN CORRECTION ACF TRIAL SPACER HANDLE
07611819473119ACF HOLDER
H9816900300ANTERIOR CERVICAL FUSION INSTRUMENT SET GRAPHIC CASE
H9813048240ACF GRAPHIC CASE

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