STERIFLEX HT RAHT-2X13C

GUDID M695RAHT2X13C0

STERIFLEX HT Ø2.0mm x 13mm

Tyber Medical LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device IDM695RAHT2X13C0
NIH Device Record Key7c921b53-69da-4cb1-ae58-c40851a93463
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTERIFLEX HT
Version Model NumberRAHT-2X13C
Catalog NumberRAHT-2X13C
Company DUNS010968002
Company NameTyber Medical LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM695RAHT2X13C0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-01-17
Device Publish Date2019-08-23

On-Brand Devices [STERIFLEX HT]

M695RAHT2X15S100STERIFLEX HT Ø2.0mm x 15mm - 10
M695RAHT2X15C0STERIFLEX HT Ø2.0mm x 15mm
M695RAHT2X13S100STERIFLEX HT Ø2.0mm x 13mm - 10
M695RAHT2X13C0STERIFLEX HT Ø2.0mm x 13mm
M695RAHT25X15S100STERIFLEX HT Ø2.5mm x 15mm - 10
M695RAHT25X15C0STERIFLEX HT Ø2.5mm x 15mm
M695RAHT3X15C0STERIFLEX HT Ø3.0mm x 15mm
M695RAHT010110Mini Fixed AO Handle w/ Ø1.1mm Guidewire (6") Kit
M695RAHT010090Mini Fixed AO Handle w/ Ø0.9mm Guidewire (6") Kit
M695RAHT010000Mini Fixed AO Handle

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