Snap-Off Screw System Instruments 010-000001

GUDID M6950100000010

Snap Off Driver

Tyber Medical, LLC

Surgical screwdriver, reusable
Primary Device IDM6950100000010
NIH Device Record Key19c85987-4d31-493a-bd3c-4d3c587122f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSnap-Off Screw System Instruments
Version Model Number010-000001
Catalog Number010-000001
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 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

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
HIBCCM6950100000010 [Primary]

FDA Product Code

LRZScrewdriver, surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-08-15
Device Publish Date2019-08-23

Devices Manufactured by Tyber Medical, LLC

00196449008940 - UNITUS2025-08-15 8Bx8Lx8R STERILE KIT
00196449008957 - UNITUS2025-08-15 10Bx8Lx8R STERILE KIT
00196449008964 - UNITUS2025-08-15 15Bx12Lx12R STERILE KIT
00196449008971 - UNITUS2025-08-15 15Bx15Lx15R STERILE KIT
00196449008988 - UNITUS2025-08-15 18Bx18Lx18R STERILE KIT
00196449008995 - UNITUS2025-08-15 20Bx18Lx18R STERILE KIT
00196449009008 - UNITUS2025-08-15 20Bx20Lx20R STERILE KIT
00196449009015 - UNITUS2025-08-15 25Bx20Lx20R STERILE KIT

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.