Cannulated Screw System + 03.333.213S

GUDID 00819917026832

CANN COUNTERSINK FOR 4.5/5.5MM HEADED CANN SCREW + / QC - STER

Tyber Medical, LLC

Surgical countersink, single-use
Primary Device ID00819917026832
NIH Device Record Keyccb76fb0-53b4-4d60-a8b9-7d65642f3c27
Commercial Distribution StatusIn Commercial Distribution
Brand NameCannulated Screw System +
Version Model Number03.333.213S
Catalog Number03.333.213S
Company DUNS010968002
Company NameTyber Medical, LLC
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 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(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100819917026832 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2025-08-15
Device Publish Date2020-05-21

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.