Sutrazorb

FDA UDI

Class II (US FDA UDI)

by Visionary Medical Supplies, Inc.

Identity

Trade Name: Sutrazorb FDA UDI
Generic Name: Polyglycolic acid suture FDA UDI
Device Name: 8-0 Suture USP / Thread Specifications: PGA, 5 inch (13 cm) / Needle Specifications: TP-140-8, Taper Point, 3/8 (140 degrees), length 6.5mm, wire diameter 0.20 mm / # of needles: Double arm FDA UDI
Model / Reference: A84082TP FDA UDI
Description: 8-0 Suture USP / Thread Specifications: PGA, 5 inch (13 cm) / Needle Specifications: TP-140-8, Taper Point, 3/8 (140 degrees), length 6.5mm, wire diameter 0.20 mm / # of needles: Double arm FDA UDI

Identifiers

Primary DI / UDI-DI: M583A84082TP1 FDA UDI
FDA Product Code: GAM FDA UDI
GMDN Term: Polyglycolic acid suture FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4493 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

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: Outer Diameter — 0.20 Millimeter FDA UDI
Angle — 140 degree FDA UDI
Length — 6.5 Millimeter FDA UDI
Length — 13 Centimeter FDA UDI

Category: Polyglycolic acid suture

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

Similar devices

Also classified as Polyglycolic acid suture.

ATRAMAT — Internacional Farmacéutica S.A DE C.V · Class II
WEGO-PGA Absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II
MEGASORB — MERIL ENDO SURGERY PRIVATE LIMITED · Class II
MEGASORB — MERIL ENDO SURGERY PRIVATE LIMITED · Class II
WEGO-PGA Absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II
WEGO-PGA Absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II
WEGO-PGA Absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II
WEGO-PGA Absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II

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 c3b2ae05-5e22-4c24-bb0b-590c3c3f980f 36 fields · synced Jun 9, 2026