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ArcTV™ Transvaginal Sling System

FDA UDI

Class II (US FDA UDI)

by Urocure, LLC

Identity

Trade Name
ArcTV™ Transvaginal Sling System FDA UDI
Generic Name
Female stress urinary incontinence surgical mesh-sling, synthetic polymer FDA UDI
Device Name
ArcTV™ Transvaginal Sling System FDA UDI
Model / Reference
A-TV-1001 FDA UDI
Description
ArcTV™ Transvaginal Sling System FDA UDI

Identifiers

Catalog Number
A-TV-1001 FDA UDI
Primary DI / UDI-DI
00860368002401 FDA UDI
510(k) Number
K183134 FDA UDI
FDA Product Code
OTN FDA UDI
GMDN Term
Female stress urinary incontinence surgical mesh-sling, synthetic polymer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 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

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Female stress urinary incontinence surgical mesh-sling, synthetic polymer

ArcTV™ Transvaginal Sling System by Urocure, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Female stress urinary incontinence surgical mesh-sling, synthetic polymer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Urocure, LLC

Sources (1)

  • FDA UDI 2b39e4de-02c1-41c9-a345-a494ae9571d6 36 fields · synced Jun 1, 2026