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: 9-0 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 FDA UDI
Model / Reference: P90062 FDA UDI
Description: 9-0 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 FDA UDI

Identifiers

Primary DI / UDI-DI: M583P900621 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 — 0 degree FDA UDI
Outer Diameter — 0.15 Millimeter FDA UDI
Length — 16 Millimeter FDA UDI
Length — 30 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.

SUTUMED — Unilene Sac · Class II
DemeLENE — DemeTECH Corp · Class II
DemeLENE — DemeTECH Corp · Class II
ATRAMAT — Internacional Farmacéutica S.A DE C.V · Class II
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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Visionary Medical Supplies, Inc.

Sources (1)

FDA UDI 1495c543-5eee-445e-be47-4d669101b149 36 fields · synced Jun 9, 2026