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Releve

FDA UDI

Class I (US FDA UDI)

by Surgin Surgical Instrumentation, Inc.

Identity

Trade Name
Releve FDA UDI
Generic Name
Vaginal rectocele reduction instrument FDA UDI
Device Name
Intravaginal Support Device FDA UDI
Model / Reference
GY1500 FDA UDI
Description
Intravaginal Support Device FDA UDI

Identifiers

Catalog Number
GY1500 FDA UDI
Primary DI / UDI-DI
00850000610071 FDA UDI
FDA Product Code
KOH FDA UDI
GMDN Term
Vaginal rectocele reduction instrument FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
884.4520 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Vaginal rectocele reduction instrument

Releve by Surgin Surgical Instrumentation, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vaginal rectocele reduction instrument.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Surgin Surgical Instrumentation, Inc.

Sources (1)

  • FDA UDI 2d83d85b-86be-4a31-b085-065d28c58d0f 34 fields · synced Jun 6, 2026