Primary Device ID | M695HTR076098930 |
NIH Device Record Key | 45568890-df60-4169-a167-c2f33a6364a1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Orion Headed Screw System Instruments |
Version Model Number | HTR-04-609893 |
Catalog Number | HTR-04-609893 |
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 |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M695HTR076098930 [Primary] |
LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M695HTR076098930]
Moist Heat or Steam Sterilization
[M695HTR076098930]
Moist Heat or Steam Sterilization
[M695HTR076098930]
Moist Heat or Steam Sterilization
[M695HTR076098930]
Moist Heat or Steam Sterilization
[M695HTR076098930]
Moist Heat or Steam Sterilization
[M695HTR076098930]
Moist Heat or Steam Sterilization
[M695HTR076098930]
Moist Heat or Steam Sterilization
[M695HTR076098930]
Moist Heat or Steam Sterilization
[M695HTR076098930]
Moist Heat or Steam Sterilization
[M695HTR076098930]
Moist Heat or Steam Sterilization
[M695HTR076098930]
Moist Heat or Steam Sterilization
[M695HTR076098930]
Moist Heat or Steam Sterilization
[M695HTR076098930]
Moist Heat or Steam Sterilization
[M695HTR076098930]
Moist Heat or Steam Sterilization
[M695HTR076098930]
Moist Heat or Steam Sterilization
[M695HTR076098930]
Moist Heat or Steam Sterilization
[M695HTR076098930]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2024-07-24 |
Device Publish Date | 2019-12-19 |
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") |