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Greenwald Surgical Company, Inc.

FDA UDI

Class I (US FDA UDI)

by Grace Manufacturing Inc

Identity

Trade Name
Greenwald Surgical Company, Inc. FDA UDI
Generic Name
Urethral bougie, reusable FDA UDI
Device Name
Otis bougie-a-boule. stainless steel FDA UDI
Model / Reference
51900-10 FDA UDI
Description
Otis bougie-a-boule. stainless steel FDA UDI

Identifiers

Catalog Number
U419 FDA UDI
Primary DI / UDI-DI
10801334000240 FDA UDI
FDA Product Code
FAX FDA UDI
GMDN Term
Urethral bougie, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.5520 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

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

Dimensions & Sizes

Size
Catheter Gauge — 10 French FDA UDI

Category: Urethral bougie, reusable

Greenwald Surgical Company, Inc. by Grace Manufacturing Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urethral bougie, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Grace Manufacturing Inc

Sources (1)

  • FDA UDI 16023736-6c19-46c6-8210-c19e57d99639 35 fields · synced Jun 1, 2026