Sutralon

GUDID M583N940623

9-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 12 inch (30 cm) / Needle Specifications: ST-140-6, Spatula Tip, 3/8 (140 degrees), length 6.00 mm, wire 0.15 mm / # of needles: Double Arm

VISIONARY MEDICAL SUPPLIES INC

Nylon suture, non-bioabsorbable, monofilament
Primary Device IDM583N940623
NIH Device Record Key14f49c10-d822-4227-8400-67d260502628
Commercial Distribution StatusIn Commercial Distribution
Brand NameSutralon
Version Model NumberN94062
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

Device Dimensions

Angle140 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length6 Millimeter
Length30 Centimeter
Angle140 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length6 Millimeter
Length30 Centimeter
Angle140 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length6 Millimeter
Length30 Centimeter
Angle140 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length6 Millimeter
Length30 Centimeter
Angle140 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length6 Millimeter
Length30 Centimeter
Angle140 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length6 Millimeter
Length30 Centimeter
Angle140 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length6 Millimeter
Length30 Centimeter
Angle140 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length6 Millimeter
Length30 Centimeter
Angle140 degree
Device Size Text, specify0
Outer Diameter0.15 Millimeter
Length6 Millimeter
Length30 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from chemicals and oxides
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from chemicals and oxides
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from chemicals and oxides
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from chemicals and oxides
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from chemicals and oxides
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from chemicals and oxides
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from chemicals and oxides
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from chemicals and oxides
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from chemicals and oxides

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM583N940621 [Primary]
HIBCCM583N940622 [Package]
Contains: M583N940621
Package: Pouch [1 Units]
In Commercial Distribution
HIBCCM583N940623 [Package]
Contains: M583N940622
Package: Carton [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GARSuture, Nonabsorbable, Synthetic, Polyamide

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 Date2016-05-13

On-Brand Devices [Sutralon]

M583N96062310-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 12 inch (30 cm) / Needle Spe
M583N96061310-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 12 inch (30 cm) / Needle Spe
M583N9408239-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 16 inch (40 cm) / Needle Spec
M583N9408139-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 16 inch (40 cm) / Needle Spec
M583N9406239-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 12 inch (30 cm) / Needle Spec
M583N9406139-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 15cm / Needle Specifications
M583N8408238-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 16 inch (40 cm) / Needle Spec
M583N74092TP37-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 30 cm / Needle Specifications
M583N64011236-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 30 inch (76 cm) / Needle Spec
M583N106062310-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 12 inch (30 cm) / Needle Spe
M583N106061310-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 6 inch (15 cm) / Needle Spec
M583N104082310-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 16 inch (40 cm) / Needle Spe
M583N104081310-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 16 inch (40 cm) / Needle Spe
M583N104062310-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 12 inch (30 cm) / Needle Spe
M583N104061310-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 6 inch (15 cm) / Needle Spec
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.