FDA.reportPublic FDA data

Sutralene

Primary DI
M583P9006221
Brand
Sutralene
Company
VISIONARY MEDICAL SUPPLIES INC
Model
P90062-2
Device description
9-0 Suture USP / Thread Specifications: Polypropylene, Monofilament, 5 cm / Needle Specifications: ST-000-6, Spatula Tip, straight (0 degrees), length 16 mm, wire 0.15 mm Double armed
Published
2016-09-06
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
M583P9006222PackageHIBCC1In Commercial Distribution
M583P9006223PackageHIBCC12In Commercial Distribution
M583P9006221PrimaryHIBCC0

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle0degree
Angle160degree
Device Size Text, specify0
Length5Centimeter
Length16Millimeter
Outer Diameter0.15Millimeter

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
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
M583N940821SutralonN940822016-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04046964791468OPTILENEB BRAUN SURGICAL SAGAW2018-05-03
04046964791505OPTILENEB BRAUN SURGICAL SAGAW2018-05-03
04046964791529OPTILENEB BRAUN SURGICAL SAGAW2018-05-03
04046964791543OPTILENEB BRAUN SURGICAL SAGAW2018-05-03
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04046964792045OPTILENEB BRAUN SURGICAL SAGAW2018-05-03
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04046964792229OPTILENEB BRAUN SURGICAL SAGAW2018-05-03
04046964709104OPTILENEB BRAUN SURGICAL SAGAW2018-04-23
04046964791901OPTILENEB BRAUN SURGICAL SAGAW2018-04-17
04046964708985OPTILENEB BRAUN SURGICAL SAGAW2016-12-12
04046964791406OPTILENEB BRAUN SURGICAL SAGAW2016-12-11
04046964791567OPTILENEB BRAUN SURGICAL SAGAW2016-12-11
04046964791581OPTILENEB BRAUN SURGICAL SAGAW2016-12-11
04046964791680OPTILENEB BRAUN SURGICAL SAGAW2016-12-11
04046964791703OPTILENEB BRAUN SURGICAL SAGAW2016-12-11
04046964791826OPTILENEB BRAUN SURGICAL SAGAW2016-12-11
04046964791864OPTILENEB BRAUN SURGICAL SAGAW2016-12-11
04046964791888OPTILENEB BRAUN SURGICAL SAGAW2016-12-11
04046964791925OPTILENEB BRAUN SURGICAL SAGAW2016-12-11
04046964791949OPTILENEB BRAUN SURGICAL SAGAW2016-12-11