Sutralene

GUDID M583P1000623

10-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 8 inch (20 cm) / Needle Specifications: ST-000-6, Spatula Tip, straight (0 degrees), length 16 mm, wire 0.15 mm / # of needles: Double arm

VISIONARY MEDICAL SUPPLIES INC

Polyolefin suture, monofilament
Primary Device IDM583P1000623
NIH Device Record Keya6480ba0-6949-43c3-9ccb-56cfaacabc7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSutralene
Version Model NumberP100062
Company DUNS111585795
Company NameVISIONARY MEDICAL SUPPLIES INC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone608-270-3880
Emailinfo@visionarymedicalsupplies.com
Phone608-270-3880
Emailinfo@visionarymedicalsupplies.com
Phone608-270-3880
Emailinfo@visionarymedicalsupplies.com
Phone608-270-3880
Emailinfo@visionarymedicalsupplies.com
Phone608-270-3880
Emailinfo@visionarymedicalsupplies.com
Phone608-270-3880
Emailinfo@visionarymedicalsupplies.com
Phone608-270-3880
Emailinfo@visionarymedicalsupplies.com
Phone608-270-3880
Emailinfo@visionarymedicalsupplies.com
Phone608-270-3880
Emailinfo@visionarymedicalsupplies.com
Phone608-270-3880
Emailinfo@visionarymedicalsupplies.com
Phone608-270-3880
Emailinfo@visionarymedicalsupplies.com
Phone608-270-3880
Emailinfo@visionarymedicalsupplies.com
Phone608-270-3880
Emailinfo@visionarymedicalsupplies.com
Phone608-270-3880
Emailinfo@visionarymedicalsupplies.com
Phone608-270-3880
Emailinfo@visionarymedicalsupplies.com
Phone608-270-3880
Emailinfo@visionarymedicalsupplies.com
Phone608-270-3880
Emailinfo@visionarymedicalsupplies.com
Phone608-270-3880
Emailinfo@visionarymedicalsupplies.com
Phone608-270-3880
Emailinfo@visionarymedicalsupplies.com
Phone608-270-3880
Emailinfo@visionarymedicalsupplies.com
Phone608-270-3880
Emailinfo@visionarymedicalsupplies.com

Device Dimensions

Angle0 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length16 Millimeter
Length20 Centimeter
Angle0 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length16 Millimeter
Length20 Centimeter
Angle0 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length16 Millimeter
Length20 Centimeter
Angle0 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length16 Millimeter
Length20 Centimeter
Angle0 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length16 Millimeter
Length20 Centimeter
Angle0 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length16 Millimeter
Length20 Centimeter
Angle0 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length16 Millimeter
Length20 Centimeter
Angle0 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length16 Millimeter
Length20 Centimeter
Angle0 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length16 Millimeter
Length20 Centimeter
Angle0 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length16 Millimeter
Length20 Centimeter
Angle0 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length16 Millimeter
Length20 Centimeter
Angle0 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length16 Millimeter
Length20 Centimeter
Angle0 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length16 Millimeter
Length20 Centimeter
Angle0 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length16 Millimeter
Length20 Centimeter
Angle0 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length16 Millimeter
Length20 Centimeter
Angle0 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length16 Millimeter
Length20 Centimeter
Angle0 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length16 Millimeter
Length20 Centimeter
Angle0 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length16 Millimeter
Length20 Centimeter
Angle0 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length16 Millimeter
Length20 Centimeter
Angle0 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length16 Millimeter
Length20 Centimeter
Angle0 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length16 Millimeter
Length20 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM583P1000621 [Primary]
HIBCCM583P1000622 [Package]
Contains: M583P1000621
Package: Pouch [1 Units]
In Commercial Distribution
HIBCCM583P1000623 [Package]
Contains: M583P1000622
Package: Carton [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAWSuture, Nonabsorbable, Synthetic, Polypropylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-02-05
Device Publish Date2016-06-14

On-Brand Devices [Sutralene]

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M583P900906239-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 12 inch (30 cm) / Need
M583P90062239-0 Suture USP / Thread Specifications: Polypropylene, Monofilament, 5 cm / Needle Specification
M583P9006239-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 8 inch (20 cm) / Needl
M583P900606239-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 12 inch (30 cm) / Need
M583P540151RC35-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 28 inch (70 cm) / Need
M583P109062TP310-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 8 inch (20 cm) / Need
M583P100062310-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 8 inch (20 cm) / Need
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