FDA.reportPublic FDA data

Sutrasilk

Primary DI
M583S6401123
Brand
Sutrasilk
Company
VISIONARY MEDICAL SUPPLIES INC
Model
S640112
Device description
6-0 Suture USP / Thread Specifications: Silk, Black Braided, 30 inch (76 cm) / Needle Specifications: ST-140-11, Spatula Tip, 3/8 circle (140 degrees), length 8.0 mm, wire 0.28mm / # of needles: Double arm
Published
2016-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAPSuture, Nonabsorbable, Silk

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAPSuture, Nonabsorbable, SilkGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K994177000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K994177000SUTRASILK SILK SUTUREVisionary Medical Supplies, Inc.2000-02-08GAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M583S6401122PackageHIBCC1In Commercial Distribution
M583S6401123PackageHIBCC12In Commercial Distribution
M583S6401121PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Silk sutureA natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) 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. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle140degree
Device Size Text, specify0
Length8Millimeter
Length76Centimeter
Outer Diameter0.28Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
111585795
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
M583N1060621SutralonN1060622016-05-13
M583N6401121SutralonN6401122016-05-13
M583N74092TP1SutralonN74092TP2016-09-06
M583N840821SutralonN840822016-05-13
M583N940611SutralonN940612016-09-06
M583N940621SutralonN940622016-05-13
M583N940811SutralonN940812016-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07757093028192SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028222SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028260SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028536SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028734SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028833SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028888SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028956SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028987SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029014SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029236SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029366SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029373SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029427SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029489SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029502SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029540SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029564SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029595SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029601SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093218463SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029809SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093029854SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093029878SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093029892SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030027SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030089SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030256SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030294SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030331SUTUMEDUnilene S.A.C.GAP2023-01-06