FDA.reportPublic FDA data

Phantom Fiber™ Suture

Primary DI
00846832011728
Brand
Phantom Fiber™ Suture
Company
TORNIER, INC.
Model
SMSB0130
Catalog number
SMSB0130
Published
2015-10-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NWJSuture, recombinant technology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWJSuture, Recombinant TechnologyGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130422000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130422000PHANTOM FIBER BIOFIBER SUTURETornier, Inc.2013-04-04NWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846832011728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846832011728008468320117288468320117280846832011728

GMDN Terms#

Term, Definition table
TermDefinition
Polyhydroxybutyrate sutureA sterile, single-strand (monofilament), synthetic, bioabsorbable thread derived from poly-4-hydroxybutyrate [a material isolated from prokaryotic cells using recombinant deoxyribonucleic acid (DNA) technology] intended to join (approximate) the edges of a soft-tissue wound or incision by stitching, or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length91Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)494-7950customerservice@tornier.com

Regulatory Flags#

DUNS number
968990812
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846832085675TORNIER PERFORM™ REVERSEDDWJ1017304DWJ10173042022-01-05
00846832085682TORNIER PERFORM™ REVERSEDDWJ1017305DWJ10173052022-01-05
00846832085699TORNIER PERFORM™ REVERSEDDWJ1017306DWJ10173062022-01-05
00846832085705TORNIER PERFORM™ REVERSEDDWJ1017307DWJ10173072022-01-05
00846832085743TORNIER PERFORM™ REVERSEDDWJ1017204DWJ10172042022-01-05
00846832085750TORNIER PERFORM™ REVERSEDDWJ1017205DWJ10172052022-01-05
00846832085767TORNIER PERFORM™ REVERSEDDWJ1017206DWJ10172062022-01-05
00846832085774TORNIER PERFORM™ REVERSEDDWJ1017207DWJ10172072022-01-05
00846832085781TORNIER PERFORM™ REVERSEDDWJ1017701DWJ10177012022-01-05
00846832085798TORNIER PERFORM™ REVERSEDDWJ1017702DWJ10177022022-01-05
00846832085804TORNIER PERFORM™ REVERSEDDWJ1017703DWJ10177032022-01-05
00846832085811TORNIER PERFORM™ REVERSEDDWJ1017601DWJ10176012022-01-05
00846832085828TORNIER PERFORM™ REVERSEDDWJ1017602DWJ10176022022-01-05
00846832085835TORNIER PERFORM™ REVERSEDDWJ1017603DWJ10176032022-01-05
00846832092086Tornier Perform® Reversed Augmented GlenoidDWJ513DWJ5132022-05-10
00846832092093Tornier Perform® Reversed Augmented GlenoidDWJ503DWJ5032022-05-10
00846832092109Tornier Perform® Reversed Augmented GlenoidDWJ505DWJ5052022-05-10
00846832092123Tornier Perform® Reversed Augmented GlenoidDWJ502DWJ5022022-05-10
00846832092130Tornier Perform® Reversed Augmented GlenoidDWJ514DWJ5142022-05-10
00846832092147Tornier Perform® Reversed Augmented GlenoidDWJ515DWJ5152022-05-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046964732546MONOMAXB BRAUN SURGICAL SANWJ2018-05-03
04046963489939MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963489953MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963489977MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963489991MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963490317MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963490331MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963490379MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963490386MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963490409MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963490423MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963490447MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963490461MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963490485MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963490508MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963490522MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963508784MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510107MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510121MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510145MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510169MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510183MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510220MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510244MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510268MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510282MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510305MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510329MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510343MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510367MONOMAXB BRAUN SURGICAL SANWJ2016-11-25