Tornier HRS ARS742204

GUDID 00840338602732

Sounder

TORNIER, INC.

Orthopaedic prosthesis implantation instrument, reusable
Primary Device ID00840338602732
NIH Device Record Key1d5bf18f-5b30-4a5e-a8a7-241f869d835a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTornier HRS
Version Model NumberARS742204
Catalog NumberARS742204
Company DUNS968990812
Company NameTORNIER, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
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
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 Dimensions

Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840338602732 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


[00840338602732]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-01
Device Publish Date2023-04-21

On-Brand Devices [Tornier HRS]

00840338602756Sounder
00840338602749Sounder
00840338602732Sounder
00840338602725Sounder
00840338602718Sounder
00840338602701Sounder
00846832093502PTC Partially Coated Distal Stem
00846832093298Assembly Screw
00846832093274Assembly Screw
00846832093250Assembly Screw
00846832093212PTC Distal Stem
00846832093205PTC Distal Stem
00846832093182PTC Distal Stem
00846832093175PTC Distal Stem
00846832093151PTC Distal Stem
00846832093144PTC Distal Stem
00846832093113PTC Distal Stem
00846832093083PTC Distal Stem
00846832093069PTC Distal Stem
00846832093052PTC Distal Stem
00846832093045PTC Distal Stem
00846832093038PTC Distal Stem
00846832093014PTC Distal Stem
00846832092956PTC Partially Coated Distal Stem
00846832092925PTC Partially Coated Distal Stem
00846832092918PTC Partially Coated Distal Stem
00846832092901PTC Partially Coated Distal Stem
00846832092895PTC Partially Coated Distal Stem
00846832092888PTC Partially Coated Distal Stem
00846832092871PTC Partially Coated Distal Stem
00846832092857PTC Partially Coated Distal Stem
00846832092840PTC Partially Coated Distal Stem
00846832092833PTC Partially Coated Distal Stem
00846832092826PTC Partially Coated Distal Stem
00846832092765PTC Proximal Body
00846832092758PTC Proximal Body
00846832092741PTC Proximal Body
00846832092734PTC Proximal Body
00846832092727PTC Proximal Body
00846832092680Spacer
00846832092673Spacer
00846832092666Spacer
00846832092628Spacer
00846832092611Spacer
00846832092604Spacer
00846832092598Spacer
00846832093557PTC Partially Coated Distal Stem
00846832093540PTC Partially Coated Distal Stem
00846832093526PTC Partially Coated Distal Stem
00846832093236PTC Distal Stem

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.