Home GUDID M583N940823 Sutralon
Primary DI M583N940823
Brand Sutralon
Company VISIONARY MEDICAL SUPPLIES INC
Model N94082
Device description 9-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 16 inch (40 cm) / Needle Specifications: ST-140-8, Spatula Tip, 3/8 (140 degrees), length 6.00 mm, wire 0.20 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
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name GAR Suture, Nonabsorbable, Synthetic, Polyamide
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GAR Suture, Nonabsorbable, Synthetic, Polyamide General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M583N940822 Package HIBCC 1 In Commercial Distribution M583N940823 Package HIBCC 12 In Commercial Distribution M583N940821 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Nylon suture, non-bioabsorbable, monofilament A 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 Type Value Unit Angle 140 degree Device Size Text, specify 0 Length 6 Millimeter Length 40 Centimeter Outer Diameter 0.2 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep away from chemicals and oxides
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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00814639026856 UNIFY Nylon Surgical Sutures APPLIED DENTAL, INC. GAR 2026-08-07 00814639026863 UNIFY Nylon Surgical Sutures APPLIED DENTAL, INC. GAR 2026-08-07 00860011435938 TAS Medical, Inc. Tissue Approximation System TAS Medical, Inc. GAR 2026-08-01 00860011435945 TAS Medical, Inc. Tissue Approximation System TAS Medical, Inc. GAR 2026-08-01 00860011435952 TAS Medical, Inc. Tissue Approximation System TAS Medical, Inc. GAR 2026-08-01 00860011435969 TAS Medical, Inc. Tissue Approximation System TAS Medical, Inc. GAR 2026-08-01 10705031088054 ETHILON ETHICON, LLC GAR 2026-07-03 10705031089600 ETHILON ETHICON, LLC GAR 2026-07-03 10705031097018 ETHILON ETHICON, LLC GAR 2026-07-03 10705031099975 ETHILON ETHICON, LLC GAR 2026-07-03 07757093013747 SUTUMED Unilene S.A.C. GAR 2024-09-19 07757093013891 SUTUMED Unilene S.A.C. GAR 2024-09-19 07757093013068 SUTUMED Unilene S.A.C. GAR 2023-01-06 07757093013280 SUTUMED Unilene S.A.C. GAR 2023-01-06 07757093013563 SUTUMED Unilene S.A.C. GAR 2023-01-06 07757093013587 SUTUMED Unilene S.A.C. GAR 2023-01-06 07757093013600 SUTUMED Unilene S.A.C. GAR 2023-01-06 07757093013877 SUTUMED Unilene S.A.C. GAR 2023-01-06 07757093013952 SUTUMED Unilene S.A.C. GAR 2023-01-06 07757093014041 SUTUMED Unilene S.A.C. GAR 2023-01-06 07757093014096 SUTUMED Unilene S.A.C. GAR 2023-01-06 07757093014188 SUTUMED Unilene S.A.C. GAR 2023-01-06 07757093014362 SUTUMED Unilene S.A.C. GAR 2023-01-06 07757093014393 SUTUMED Unilene S.A.C. GAR 2023-01-06 07757093014560 SUTUMED Unilene S.A.C. GAR 2023-01-06 07757093014713 SUTUMED Unilene S.A.C. GAR 2023-01-06 07757093014744 SUTUMED Unilene S.A.C. GAR 2023-01-06 07757093014768 SUTUMED Unilene S.A.C. GAR 2023-01-06 07757093014881 SUTUMED Unilene S.A.C. GAR 2023-01-06 07757093014898 SUTUMED Unilene S.A.C. GAR 2023-01-06