Tornier HRS Max ARS10245

GUDID 00840338603937

Inserter & Extractor Handle

TORNIER, INC.

Surgical instrument handle, non-torque-limiting
Primary Device ID00840338603937
NIH Device Record Key3d6718cc-0cfe-40a4-9ec9-fd9a27319b99
Commercial Distribution StatusIn Commercial Distribution
Brand NameTornier HRS Max
Version Model NumberARS10245
Catalog NumberARS10245
Company DUNS968990812
Company NameTORNIER, INC.
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840338603937 [Primary]

FDA Product Code

HWAIMPACTOR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840338603937]

Moist Heat or Steam Sterilization


[00840338603937]

Moist Heat or Steam Sterilization


[00840338603937]

Moist Heat or Steam Sterilization


[00840338603937]

Moist Heat or Steam Sterilization


[00840338603937]

Moist Heat or Steam Sterilization


[00840338603937]

Moist Heat or Steam Sterilization


[00840338603937]

Moist Heat or Steam Sterilization


[00840338603937]

Moist Heat or Steam Sterilization


[00840338603937]

Moist Heat or Steam Sterilization


[00840338603937]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-11-26
Device Publish Date2025-11-18

On-Brand Devices [Tornier HRS Max]

00840338612229Deep Image Aluminum Lid
00840338607379Instrument Tray Assembly
00840338604101Instrument Case Base
00840338604095Instrument Inner Tray
00840338604088Taper Breaker
00840338604071Impactor Tip
00840338604064Impaction Stand
00840338604057Trial Alignment Peg
00840338604040Trial Tuberosity Body
00840338604033Trial Tuberosity Body
00840338604026Trial Proximal Body
00840338604019Trial Proximal Body
00840338604002Trial Proximal Body
00840338603999Trial Spacer
00840338603982Trial Spacer
00840338603975Trial Spacer
00840338603968Trial Spacer
00840338603951Height Gauge Tower
00840338603944Height Gauge Clamp
00840338603937Inserter & Extractor Handle
00840338603920Expanding Trial
00840338603913Expanding Trial
00840338603906Expanding Trial
00840338603890Expanding Trial
00840338603883Expanding Trial
00840338603876Expanding Trial
00840338603869Expanding Trial
00840338603852Expanding Trial
00840338603845Expanding Trial
00840338603838Expanding Trial
00840338603821Expanding Trial
00840338603708Drop Rod
00840338603692Saw Guide
00840338603685Bone Clamp

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.