Flex Anchor Deployment Driver ODI-T134

GUDID B058ODIT1341

Flex Anchor Deployment Driver

Orthopedic Designs North America, Inc.

Surgical screwdriver, reusable
Primary Device IDB058ODIT1341
NIH Device Record Key2898328d-681a-44c9-bf66-dda0d01fbd37
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlex Anchor Deployment Driver
Version Model NumberODIT134
Catalog NumberODI-T134
Company DUNS945518848
Company NameOrthopedic Designs North America, Inc.
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB058ODIT1341 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B058ODIT1341]

Moist Heat or Steam Sterilization


[B058ODIT1341]

Moist Heat or Steam Sterilization


[B058ODIT1341]

Moist Heat or Steam Sterilization


[B058ODIT1341]

Moist Heat or Steam Sterilization


[B058ODIT1341]

Moist Heat or Steam Sterilization


[B058ODIT1341]

Moist Heat or Steam Sterilization


[B058ODIT1341]

Moist Heat or Steam Sterilization


[B058ODIT1341]

Moist Heat or Steam Sterilization


[B058ODIT1341]

Moist Heat or Steam Sterilization


[B058ODIT1341]

Moist Heat or Steam Sterilization


[B058ODIT1341]

Moist Heat or Steam Sterilization


[B058ODIT1341]

Moist Heat or Steam Sterilization


[B058ODIT1341]

Moist Heat or Steam Sterilization


[B058ODIT1341]

Moist Heat or Steam Sterilization


[B058ODIT1341]

Moist Heat or Steam Sterilization


[B058ODIT1341]

Moist Heat or Steam Sterilization


[B058ODIT1341]

Moist Heat or Steam Sterilization


[B058ODIT1341]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-30
Device Publish Date2023-06-22

Devices Manufactured by Orthopedic Designs North America, Inc.

B058CCD0912NS1 - Cannulated Compression Device (CCD) System2024-07-29 CCD Compression Nut - Compressive (non-sterile)
B058CCD0915NS1 - Cannulated Compression Device (CCD) System2024-07-29 CCD Compression Nut - Neutral (non-sterile)
B058CCD7516045NS1 - Cannulated Compression Device (CCD) System2024-07-29 Cannulated Compression Device - 045mm - 16mm (non-sterile)
B058CCD7516050NS1 - Cannulated Compression Device (CCD) System2024-07-29 Cannulated Compression Device - 050mm - 16mm (non-sterile)
B058CCD7516055NS1 - Cannulated Compression Device (CCD) System2024-07-29 Cannulated Compression Device - 055mm - 16mm (non-sterile)
B058CCD7516060NS1 - Cannulated Compression Device (CCD) System2024-07-29 Cannulated Compression Device - 060mm - 16mm (non-sterile)
B058CCD7516065NS1 - Cannulated Compression Device (CCD) System2024-07-29 Cannulated Compression Device - 065mm - 16mm (non-sterile)
B058CCD7516070NS1 - Cannulated Compression Device (CCD) System2024-07-29 Cannulated Compression Device - 070mm - 16mm (non-sterile)

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