Orion Headed Screw System Instruments HTR-04-009735

GUDID M695HTR040097350

6" Depth Gauge

Tyber Medical LLC

Surgical depth gauge, reusable

• Primary Device ID: M695HTR040097350
• NIH Device Record Key: c726bf18-5679-4c2d-82da-e56f1113aca7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orion Headed Screw System Instruments
• Version Model Number: HTR-04-009735
• Catalog Number: HTR-04-009735
• Company DUNS: 010968002
• Company Name: Tyber Medical LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
• 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
HIBCC	M695HTR040097350 [Primary]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

[M695HTR040097350]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-07-25
• Device Publish Date: 2019-12-19

On-Brand Devices [Orion Headed Screw System Instruments]

• M695HTR040092090: discectomy Instrument Tray
• M695HTR076098930: Ø1.6mm Drill - Cannulated, AO Quick Coupling
• M695HTR041499090: Ø4.5mm (9") Drill
• M695HTR041398660: Ø3.0mm (6") Drill
• M695HTR041298160: Ø2.0mm (6") Drill
• M695HTR040099380: 2.0 Screw Countersink
• M695HTR040097360: 9" Depth Gauge
• M695HTR040097350: 6" Depth Gauge
• M695HTR040096300: Tissue Protector 2.0mm x 4.5mm
• M695HTR040096250: Tissue Protector 1.1mm x 2.0mm
• M695HTR040095270: Tissue Protector 1.6mm x 3.0mm
• M695HTR040095240: Tissue Protector 0.9mm x 1.6mm
• M695HTR040095090: Ratcheting AO Handle
• M695HTR040095080: Mini Fixed AO Handle
• M695HTR040094130: T25 (Ø2.0) Torx Driver
• M695HTR040094110: T8 (Ø1.1) Torx Driver
• M695HTR040093510: Ø0.9mm Guidewire Dispenser
• M695HTR040093120: T15 (Ø1.6) Torx Driver
• M695HTR040093100: T6 (Ø0.9) Torx Driver
• M695HTR040092060: Ø2.0mm Guidewire (9")
• M695HTR040092030: Ø1.1mm Guidewire (6")
• M695HTR040091040: Ø1.6mm Guidewire (6")
• M695HTR040091020: Ø0.9 mm Guidewire (6")