Cannulated Compression Headless Screw 04.333.442TS

GUDID 00819917028508

4.0MM TI CANN COMPRESSION HEADLESS SCREW- ST- 42MM

Tyber Medical LLC

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00819917028508
• NIH Device Record Key: ee7387aa-81d0-4a70-a44a-2d27e5a68259
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cannulated Compression Headless Screw
• Version Model Number: 04.333.442TS
• Catalog Number: 04.333.442TS
• Company DUNS: 010968002
• Company Name: Tyber Medical LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819917028508 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133842

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-20
• Device Publish Date: 2019-12-10

On-Brand Devices [Cannulated Compression Headless Screw]

• 00819917027075: 9.0MM/2.8MM GUIDE WIRE SLEEVE
• 00819917027051: 11.0MM/9.0MM TISSUE PROTECTOR
• 00819917027044: 7.5MM/1.6MM GUIDE WIRE SLEEVE
• 00819917027020: 9.5 MM/7.5MM TISSUE PROTECTOR
• 00819917027013: CANN SCRWDRVR HANDLE WITH RATCHET LG QUICK COUPLING
• 00819917027006: CANN SCRWDRVR HANDLE WITH RATCHET QUICK COUPLING
• 00819917026993: CANN SCRWDRVR HANDLE WITH JWLRS CAP QUICK COUPLING
• 00819917026986: DIRECT MEASURING DEVICE FOR 220MM WIRE
• 00819917026979: DIRECT MEASURING DEVICE FOR 150MM WIRE
• 00819917026962: DIRECT MEASURING DEVICE FOR 100MM WIRE
• 00819917026955: 5.0MM/2.8MM DOUBLE DRILL GUIDE
• 00819917026948: 3.0MM/1.6MM DOUBLE DRILL GUIDE
• 00819917026931: 2.7MM/1.4MM DOUBLE DRILL GUIDE
• 00819917026924: 2.0MM/1.1MM DOUBLE DRILL GUIDE
• 00819917026917: 1.6MM/0.8MM DOUBLE DRILL GUIDE
• 00819917026900: T30 CANN STRDRV SCRWDRVR SHAFT SLF-RETAIN
• 00819917026894: T15 CANN STRDRV SCRWDRVR SHAFT SLF-RETAIN
• 00819917026887: T8 STRDRV SCRWDRVR SHAFT SLF-RETAIN
• 00819917026870: T8 CANN STRDRV SCRWDRVR SHAFT SLF-RETAIN
• 00819917026863: T6 STRDRV SCRWDRVR SHAFT SLF-RETAIN
• 00819917026856: T6 CANN STRDRV SCRWDRVR SHAFT SLF-RETAIN
• 00819917026696: CANN COUNTERSINK FOR 6.5MM/7.5MM CANN HEADLESS SCREW/LARGE QC
• 00819917026689: CANN COUNTERSINK FOR 4.5MM/5.5MM CANN HEADLESS SCREW/QC
• 00819917026672: CANN COUNTERSINK FOR 3.5MM/4.0MM CANN HEADLESS SCREW/QC
• 00819917026665: CANN COUNTERSINK FOR 2.5MM/3.0MM CANN HEADLESS SCREW/QC
• 00819917026658: CANN COUNTERSINK FOR 2.0MM CANN HEADLESS SCREW/QC
• 00819917026597: 5.0MM CANN DRILL BIT LARGE QC/ 215MM
• 00819917026580: 3.0MM CANN DRILL BIT QC/ 215MM
• 00819917026573: 2.7MM CANN DRILL BIT QC/ 145MM
• 00819917026566: 2.0MM CANN DRILL BIT QC/ 145MM
• 00819917026559: 1.6MM CANN DRILL BIT QC/ 95MM
• 00819917026481: 2.8MM GUIDE WIRE/ 300MM LENGTH FLUTED TIP
• 00819917026474: 2.8MM GUIDE WIRE/ 220MM LENGTH FLUTED TIP
• 00819917026467: 1.6MM GUIDE WIRE/ 220MM LENGTH TROCAR TIP
• 00819917026450: 1.4MM GUIDE WIRE / 150MM LENGTH TROCAR TIP
• 00819917026443: 1.1MM GUIDE WIRE/ 150MM LENGTH TROCAR TIP
• 00819917026436: 0.8MM GUIDE WIRE/ 100MM LENGTH TROCAR TIP
• 00819917026429: 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 140MM
• 00819917026412: 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 135MM
• 00819917026405: 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 130MM
• 00819917026399: 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 125MM
• 00819917026382: 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 120MM
• 00819917026375: 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 115MM
• 00819917026368: 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 110MM
• 00819917026351: 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 105MM
• 00819917026344: 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 100MM
• 00819917026337: 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 95MM
• 00819917026320: 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 90MM
• 00819917026313: 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 85MM
• 00819917026306: 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 80MM