Greenwald Surgical Company, Inc.

Primary DI
10801334001162
Brand
Greenwald Surgical Company, Inc.
Company
GRACE MANUFACTURING, INC.
Model
52020-22
Catalog number
U420
Device description
Friedman-Otis Bougie-a-Boule, with 3 (graduated) olive tips on one stem. Mirror finish, stainless steel, precision machined.
Published
2016-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FAXBougie, Urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAXBougie, UrologicalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801334001162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080133400116210801334001162

GMDN Terms#

Term, Definition table
TermDefinition
Urethral bougie, reusableA rod-like manual surgical instrument designed to explore the urethra and/or to dilate a urethral and/or urinary meatus stenosis. It is designed with a semi-rigid tapered shaft that terminates at the distal end in a small bulbous tip (an olive) and it typically has a handle at the proximal end. It may be hollow to enable passage of other slender devices. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge18French
Catheter Gauge20French
Catheter Gauge22French

Sterilization Methods#

Method table
Method
"[""Liquid Chemical"", ""Moist Heat or Steam Sterilization""]"

Regulatory Flags#

DUNS number
607903382
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801334001469Greenwald Surgical Company, Inc.51100-00U4032016-09-23
10801334001476Greenwald Surgical Company, Inc.51100-15U4032016-09-23
10801334001483Greenwald Surgical Company, Inc.51100-30U4032016-09-23
10801334000158Greenwald Surgical Company, Inc.54210-00U4102016-10-31
10801334000165Greenwald Surgical Company, Inc.54240-00U4132016-10-31
10801334000363Greenwald Surgical Company, Inc.54230-00U4122016-10-31
10801334000257Greenwald Surgical Company, Inc22549-00P66D2016-09-23
10801334004804Greenwald Surgical Company, Inc.26502-12EET107B2022-03-21
10801334011918Greenwald Surgical Company, Inc.51300-00U5402016-09-23
10801334000141Greenwald Surgical Company, Inc.54000-04U414L2016-10-31
10801334000561Greenwald Surgical Company, Inc.54150-00U4152016-10-31
10801334000592Greenwald Surgical Company, Inc.C8022-002016-10-31
10801334000745Greenwald Surgical Company, Inc.C8021-002016-10-31
10801334000905Greenwald Surgical Company, Inc.54000-03U414R2016-10-31
10801334005696Greenwald Surgical Company, Inc.C8020-002016-10-31
10801334007423Greenwald Surgical Company, Inc.C9809-002016-10-31
10801334012014Greenwald Surgical Company, Inc.54000-02U414J2016-10-31
10801334009953Greenwald Surgical Co. Inc.25823-05CET107C2017-04-26
10801334000127Greenwald Surgical Company, Inc.53200-06U3202016-10-31
10801334000134Greenwald Surgical Company, Inc.53230-06U3232016-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810143905809SURGIPROSSurgipros, LLCFAX2026-06-01
00810143905816SURGIPROSSurgipros, LLCFAX2026-06-01
00810143905823SURGIPROSSurgipros, LLCFAX2026-06-01
00810143905830SURGIPROSSurgipros, LLCFAX2026-06-01
00810143905847SURGIPROSSurgipros, LLCFAX2026-06-01
00810143905854SURGIPROSSurgipros, LLCFAX2026-06-01
00810143905861SURGIPROSSurgipros, LLCFAX2026-06-01
00810143905878SURGIPROSSurgipros, LLCFAX2026-06-01
00810143905885SURGIPROSSurgipros, LLCFAX2026-06-01
00810143905892SURGIPROSSurgipros, LLCFAX2026-06-01
00810143905908SURGIPROSSurgipros, LLCFAX2026-06-01
00810143905915SURGIPROSSurgipros, LLCFAX2026-06-01
04049197548434RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-09-20
04049197548441RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-09-20
04049197181723RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181730RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181754RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181761RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181785RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181792RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181815RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181822RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181846RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181853RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181877RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181884RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181907RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181914RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181938RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181945RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28