Phantom Fiber™ Suture

GUDID 00846832011681

TORNIER, INC.

Polyhydroxybutyrate suture
Primary Device ID00846832011681
NIH Device Record Key1bd8d0e8-f428-4eed-a622-0aa7ed03d609
Commercial Distribution Discontinuation2018-12-14
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePhantom Fiber™ Suture
Version Model NumberSMSB0120
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

Device Dimensions

Length91 Centimeter
Length91 Centimeter
Device Size Text, specify0
Length91 Centimeter
Device Size Text, specify0
Length91 Centimeter
Device Size Text, specify0
Length91 Centimeter
Device Size Text, specify0
Length91 Centimeter
Device Size Text, specify0
Length91 Centimeter
Device Size Text, specify0
Length91 Centimeter
Device Size Text, specify0
Length91 Centimeter
Device Size Text, specify0
Length91 Centimeter
Device Size Text, specify0
Length91 Centimeter
Device Size Text, specify0
Length91 Centimeter
Device Size Text, specify0
Length91 Centimeter
Device Size Text, specify0
Length91 Centimeter
Device Size Text, specify0
Length91 Centimeter
Device Size Text, specify0
Length91 Centimeter
Device Size Text, specify0
Length91 Centimeter
Device Size Text, specify0
Length91 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100846832011681 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NWJSuture, recombinant technology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-17
Device Publish Date2015-10-16

On-Brand Devices [Phantom Fiber™ Suture]

10846832011749SMSB0132
00846832011728SMSB0130
10846832011701SMSB0122
00846832011681SMSB0120
10846832011664SMSB0112
00846832011643SMSB0110

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