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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
Vaginal Support Device (Carton of 5) FDA UDI
Model / Reference
GY1500/BX5 FDA UDI
Description
Vaginal Support Device (Carton of 5) FDA UDI

Identifiers

Catalog Number
GY1500/BX5 FDA UDI
Primary DI / UDI-DI
00850000610156 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 4c16b2c5-d3d4-451e-b386-bad701b44fc6 34 fields · synced Jun 8, 2026