Orion Headed Screw System Instruments HTR-04-009203

GUDID M695HTR040092030

Ø1.1mm Guidewire (6")

Tyber Medical LLC

Orthopaedic guidewire, single-use
Primary Device IDM695HTR040092030
NIH Device Record Key320a4988-6210-4d74-a7c3-3a56c0a8c89e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrion Headed Screw System Instruments
Version Model NumberHTR-04-009203
Catalog NumberHTR-04-009203
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 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
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
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
HIBCCM695HTR040092030 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M695HTR040092030]

Moist Heat or Steam Sterilization

[M695HTR040092030]

Moist Heat or Steam Sterilization

[M695HTR040092030]

Moist Heat or Steam Sterilization

[M695HTR040092030]

Moist Heat or Steam Sterilization

[M695HTR040092030]

Moist Heat or Steam Sterilization

[M695HTR040092030]

Moist Heat or Steam Sterilization

[M695HTR040092030]

Moist Heat or Steam Sterilization

[M695HTR040092030]

Moist Heat or Steam Sterilization

[M695HTR040092030]

Moist Heat or Steam Sterilization

[M695HTR040092030]

Moist Heat or Steam Sterilization

[M695HTR040092030]

Moist Heat or Steam Sterilization

[M695HTR040092030]

Moist Heat or Steam Sterilization

[M695HTR040092030]

Moist Heat or Steam Sterilization

[M695HTR040092030]

Moist Heat or Steam Sterilization

[M695HTR040092030]

Moist Heat or Steam Sterilization

[M695HTR040092030]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-07-25
Device Publish Date2019-12-19

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M695HTR041398660Ø3.0mm (6") Drill
M695HTR041298160Ø2.0mm (6") Drill
M695HTR0400993802.0 Screw Countersink
M695HTR0400973609" Depth Gauge
M695HTR0400973506" Depth Gauge
M695HTR040096300Tissue Protector 2.0mm x 4.5mm
M695HTR040096250Tissue Protector 1.1mm x 2.0mm
M695HTR040095270Tissue Protector 1.6mm x 3.0mm
M695HTR040095240Tissue Protector 0.9mm x 1.6mm
M695HTR040095090Ratcheting AO Handle
M695HTR040095080Mini Fixed AO Handle
M695HTR040094130T25 (Ø2.0) Torx Driver
M695HTR040094110T8 (Ø1.1) Torx Driver
M695HTR040093510Ø0.9mm Guidewire Dispenser
M695HTR040093120T15 (Ø1.6) Torx Driver
M695HTR040093100T6 (Ø0.9) Torx Driver
M695HTR040092060Ø2.0mm Guidewire (9")
M695HTR040092030Ø1.1mm Guidewire (6")
M695HTR040091040Ø1.6mm Guidewire (6")
M695HTR040091020Ø0.9 mm Guidewire (6")
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