Sutralon

FDA UDI

Class II (US FDA UDI)

by Visionary Medical Supplies, Inc.

Identity

Trade Name: Sutralon FDA UDI
Generic Name: Nylon suture, non-bioabsorbable, monofilament FDA UDI
Device Name: 9-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 15cm / Needle Specifications: ST-140-6, Spatula Tip, 3/8 (140 degrees), length 6.00 mm, wire 0.15 mm / # of needles: Single Arm FDA UDI
Model / Reference: N94061 FDA UDI
Description: 9-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 15cm / Needle Specifications: ST-140-6, Spatula Tip, 3/8 (140 degrees), length 6.00 mm, wire 0.15 mm / # of needles: Single Arm FDA UDI

Identifiers

Primary DI / UDI-DI: M583N940611 FDA UDI
510(k) Number: K994176 FDA UDI
FDA Product Code: GAR FDA UDI
GMDN Term: Nylon suture, non-bioabsorbable, monofilament FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.5020 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: Length — 15 Centimeter FDA UDI
Length — 6.00 Millimeter FDA UDI
Outer Diameter — 0.15 Millimeter FDA UDI
Angle — 140 degree FDA UDI

Category: Nylon suture, non-bioabsorbable, monofilament

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

Similar devices

Also classified as Nylon suture, non-bioabsorbable, monofilament.

DemeLON — DemeTECH Corp · Class II
Henry Schein — HENRY SCHEIN, INC. · Class II
DemeLON — DemeTECH Corp · Class II
DemeLON — DemeTECH Corp · Class II
SUPRAMID — S. Jackson, Inc. · Class II
ETHILON — Ethicon Inc. · Class II
UNIFY Nylon Surgical Sutures — APPLIED DENTAL, INC. · Class II
DemeLON — DemeTECH Corp · Class II

Cleared under the same submission

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 59163804-ccb4-434c-bbef-692f53500661 37 fields · synced Jun 9, 2026