Sutralene

FDA UDI

Class II (US FDA UDI)

by Visionary Medical Supplies, Inc.

Identity

Trade Name: Sutralene FDA UDI
Generic Name: Polyolefin/fluoropolymer suture, monofilament FDA UDI
Device Name: 5-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 28 inch (70 cm) / Needle Specifications: RC-130-15, Reverse Cutting, 3/8 circle (140 degrees), length 13.1 mm, wire 0.38 mm / # of needles: single arm FDA UDI
Model / Reference: P540151RC FDA UDI
Description: 5-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 28 inch (70 cm) / Needle Specifications: RC-130-15, Reverse Cutting, 3/8 circle (140 degrees), length 13.1 mm, wire 0.38 mm / # of needles: single arm FDA UDI

Identifiers

Primary DI / UDI-DI: M583P540151RC1 FDA UDI
510(k) Number: K070243 FDA UDI
FDA Product Code: GAW FDA UDI
GMDN Term: Polyolefin/fluoropolymer suture, monofilament FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.5010 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Angle — 140 degree FDA UDI
Outer Diameter — 0.38 Millimeter FDA UDI
Length — 13.1 Millimeter FDA UDI
Length — 70 Centimeter FDA UDI

Category: Polyolefin/fluoropolymer suture, monofilament

Sutralene by Visionary Medical Supplies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyolefin/fluoropolymer suture, monofilament.

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DemeLENE — DemeTECH Corp · Class II
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DemeLENE — DemeTECH Corp · Class II
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II
Premilene — B BRAUN SURGICAL SA · Class II
DEKNATEL — TELEFLEX INCORPORATED · Class II

Cleared under the same submission

K070243 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Visionary Medical Supplies, Inc.

Sources (1)

FDA UDI 7665963f-f5c8-4cb9-a8fd-af7889050ee4 36 fields · synced Jun 9, 2026