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Novo Surgical Inc.

FDA UDI

Class I (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name
Novo Surgical Inc. FDA UDI
Generic Name
Vaginal rectocele reduction instrument FDA UDI
Device Name
heaney hysterectomy retractor, blade 1 1/8" x 2 7/8" deep (2.9 cm x 7.3 cm), 10 1/2" (26.7 cm) FDA UDI
Model / Reference
OB6338-66 FDA UDI
Description
heaney hysterectomy retractor, blade 1 1/8" x 2 7/8" deep (2.9 cm x 7.3 cm), 10 1/2" (26.7 cm) FDA UDI

Identifiers

Catalog Number
OB6338-66 FDA UDI
Primary DI / UDI-DI
00842331189623 FDA UDI
FDA Product Code
HDL 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Vaginal rectocele reduction instrument

Novo Surgical Inc. by Novo Surgical, 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
Novo Surgical, Inc.

Sources (1)

  • FDA UDI f3b02f60-6eea-4d4c-97c2-6878c97b604c 35 fields · synced Jun 8, 2026