Compression Staple System

GUDID 00846832058822

TORNIER, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00846832058822
NIH Device Record Key7dd77229-8322-445d-99de-bc24bd02a39b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCompression Staple System
Version Model NumberSTP-003-191919
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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

Device Dimensions

Length19 Millimeter
Length19 Millimeter
Length19 Millimeter
Width19 Millimeter
Device Size Text, specify0
Length19 Millimeter
Width19 Millimeter
Device Size Text, specify0
Length19 Millimeter
Width19 Millimeter
Device Size Text, specify0
Length19 Millimeter
Width19 Millimeter
Device Size Text, specify0
Length19 Millimeter
Width19 Millimeter
Device Size Text, specify0
Length19 Millimeter
Width19 Millimeter
Device Size Text, specify0
Length19 Millimeter
Width19 Millimeter
Device Size Text, specify0
Length19 Millimeter
Width19 Millimeter
Device Size Text, specify0
Length19 Millimeter
Width19 Millimeter
Device Size Text, specify0
Length19 Millimeter
Width19 Millimeter
Device Size Text, specify0
Length19 Millimeter
Width19 Millimeter
Device Size Text, specify0
Length19 Millimeter
Width19 Millimeter
Device Size Text, specify0
Length19 Millimeter
Width19 Millimeter
Device Size Text, specify0
Length19 Millimeter
Width19 Millimeter
Device Size Text, specify0
Length19 Millimeter
Width19 Millimeter
Device Size Text, specify0
Length19 Millimeter
Width19 Millimeter
Device Size Text, specify0
Length19 Millimeter
Width19 Millimeter
Device Size Text, specify0
Length19 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100846832058822 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDRSTAPLE, FIXATION, BONE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-16

On-Brand Devices [Compression Staple System]

00846832058976STP-003-252522
00846832058969STP-003-252520
00846832058952STP-003-252516
00846832058945STP-003-252222
00846832058938STP-003-252220
00846832058921STP-003-252121
00846832058914STP-003-252020
00846832058907STP-003-252016
00846832058891STP-003-202520
00846832058884STP-003-202424
00846832058877STP-003-202323
00846832058860STP-003-202222
00846832058853STP-003-202220
00846832058846STP-003-202121
00846832058839STP-003-202016
00846832058822STP-003-191919
00846832058815STP-003-191814
00846832058808STP-003-191812
00846832058792STP-003-191717
00846832058785STP-003-191616
00846832058778STP-003-191520
00846832058761STP-003-191512
00846832058754STP-003-191510
00846832058747STP-003-161414
00846832058730STP-003-161410
00846832058723STP-003-161313
00846832058716STP-003-161210
00846832058709STP-003-161111
00846832058693STP-003-160909
00846832055302STP-003-202522
00846832055272STP-003-202020
00846832055227STP-003-191818
00846832055180STP-003-191515
00846832055159STP-003-161212
00846832055128STP-003-161010
00846832055098STP-003-160808
00846832056262DRILL GUIDE TIP
00846832056255DRILL GUIDE TIP
00846832056248DRILL GUIDE TIP
00846832056231DRILL GUIDE TIP
00846832056224DRILL GUIDE TIP
00846832056217DRILL GUIDE TIP
00846832056194DRILL GUIDE TIP
00846832056187DRILL GUIDE TIP
00846832056170DRILL GUIDE TIP
00846832056163DRILL GUIDE TIP
00846832056149DRILL GUIDE TIP
00846832056125DRILL GUIDE TIP
00846832056118DRILL GUIDE TIP
00846832056095DRILL GUIDE TIP
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