FDA.reportPublic FDA data

Sutralene

Primary DI
M583P990621
Brand
Sutralene
Company
VISIONARY MEDICAL SUPPLIES INC
Model
P99062
Device description
9-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 12 inch (30 cm) / Needle Specifications: ST-90-6, Spatula Tip, ¼ circle (90 degrees), length 16 mm, wire 0.15 mm / # of needles: Double arm
Published
2016-06-14
Public version status
Update
Distribution status
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
GAWSuture, Nonabsorbable, Synthetic, Polypropylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAWSuture, Nonabsorbable, Synthetic, PolypropyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070243000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070243000SUTRALENE POLYPROPYLENE SUTURESVisionary Medical Supplies, Inc.2007-04-17GAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M583P990622PackageHIBCC1In Commercial Distribution
M583P990623PackageHIBCC12In Commercial Distribution
M583P990621PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin/fluoropolymer suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle90degree
Device Size Text, specify0
Length16Millimeter
Length30Centimeter
Outer Diameter0.15Millimeter

Contacts#

Phone, Email table
PhoneEmail
608-270-3880info@visionarymedicalsupplies.com

Regulatory Flags#

DUNS number
111585795
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M583P1000621SutraleneP100062 2016-06-14
M583P109062TP1SutraleneP109062TP2016-06-14
M583P540151RC1SutraleneP540151RC2016-06-14
M583P90060621SutraleneP90060622016-06-14
M583P900621SutraleneP900622016-06-14
M583P9006221SutraleneP90062-22016-09-06
M583P90090621SutraleneP90090622016-06-14
M583N1040611SutralonN1040612016-05-13
M583N1040621SutralonN1040622016-05-13
M583N1040811SutralonN1040812016-09-06
M583N1040821SutralonN1040822016-05-13
M583N1060611SutralonN1060612016-05-09
M583N1060621SutralonN1060622016-05-13
M583N6401121SutralonN6401122016-05-13
M583N74092TP1SutralonN74092TP2016-09-06
M583N840821SutralonN840822016-05-13
M583N940611SutralonN940612016-09-06
M583N940621SutralonN940622016-05-13
M583N940811SutralonN940812016-09-06
M583N940821SutralonN940822016-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903837037824TruleneHEALTHIUM MEDTECH LIMITEDGAW2024-07-11
07757093024767SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024828SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024859SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024873SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025092SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025115SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025146SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025184SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025290SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025313SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025467SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025610SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025702SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025726SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025740SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025832SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026044SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026136SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026150SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026280SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026518SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093680543SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093023760SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023838SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023869SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023890SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023968SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093024033SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093024101SUTUMEDUnilene S.A.C.GAW2023-01-07