FDA.reportPublic FDA data

Sutralon

Primary DI
M583N1060621
Brand
Sutralon
Company
VISIONARY MEDICAL SUPPLIES INC
Model
N106062
Device description
10-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 12 inch (30 cm) / Needle Specifications: ST-160-6, Spatula Tip, 1/2 (160 degrees), length 5.60 mm, wire 0.15 mm / # of needles: Double arm
Published
2016-05-13
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
GARSuture, Nonabsorbable, Synthetic, Polyamide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GARSuture, Nonabsorbable, Synthetic, PolyamideGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K994176000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K994176000SUTRALON NYLON SUTURESVisionary Medical Supplies, Inc.2000-02-08GAR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M583N1060622PackageHIBCC1In Commercial Distribution
M583N1060623PackageHIBCC12In Commercial Distribution
M583N1060621PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nylon suture, non-bioabsorbable, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) 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. 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
Angle160degree
Device Size Text, specify0
Length5.6Millimeter
Length30Centimeter
Outer Diameter0.15Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from chemicals and oxides

Contacts#

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

Regulatory Flags#

DUNS number
111585795
Device count
1
DM exempt
true
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
M583P990621SutraleneP990622016-06-14
M583N1040611SutralonN1040612016-05-13
M583N1040621SutralonN1040622016-05-13
M583N1040811SutralonN1040812016-09-06
M583N1040821SutralonN1040822016-05-13
M583N1060611SutralonN1060612016-05-09
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
00814639026856UNIFY Nylon Surgical SuturesAPPLIED DENTAL, INC.GAR2026-08-07
00814639026863UNIFY Nylon Surgical SuturesAPPLIED DENTAL, INC.GAR2026-08-07
00860011435938TAS Medical, Inc. Tissue Approximation SystemTAS Medical, Inc.GAR2026-08-01
00860011435945TAS Medical, Inc. Tissue Approximation SystemTAS Medical, Inc.GAR2026-08-01
00860011435952TAS Medical, Inc. Tissue Approximation SystemTAS Medical, Inc.GAR2026-08-01
00860011435969TAS Medical, Inc. Tissue Approximation SystemTAS Medical, Inc.GAR2026-08-01
10705031088054ETHILONETHICON, LLCGAR2026-07-03
10705031089600ETHILONETHICON, LLCGAR2026-07-03
10705031097018ETHILONETHICON, LLCGAR2026-07-03
10705031099975ETHILONETHICON, LLCGAR2026-07-03
07757093013747SUTUMEDUnilene S.A.C.GAR2024-09-19
07757093013891SUTUMEDUnilene S.A.C.GAR2024-09-19
07757093013068SUTUMEDUnilene S.A.C.GAR2023-01-06
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07757093014560SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014713SUTUMEDUnilene S.A.C.GAR2023-01-06
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07757093014768SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014881SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014898SUTUMEDUnilene S.A.C.GAR2023-01-06