FDA.reportPublic FDA data

Greenwald Surgical Company, Inc.

Primary DI
10801334000134
Brand
Greenwald Surgical Company, Inc.
Company
GRACE MANUFACTURING, INC.
Model
53230-06
Catalog number
U323
Device description
Guyon Catheter Stylet. Stainless steel throughout, polished finish.
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
EZBStylet For Catheter, Gastro-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZBStylet For Catheter, Gastro-UrologyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801334000134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080133400013410801334000134

GMDN Terms#

Term, Definition table
TermDefinition
Urethral dilator, reusableA slender, solid or hollow, flexible or semi-flexible, surgical instrument designed to dilate the urethra, mainly to treat strictures of the urethra, to facilitate the extraction of stones (renal calculi), and/or to facilitate catheter placement. It is typically made of metal or plastics and is available in a range of sizes; it may include a mechanical expanding mechanism. The device may also include a dial to show the degree of expansion of the urethra and as such is usually considered a urethrometer. Urethral bougies are also used for urethral dilatation. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French

Sterilization Methods#

Method table
Method
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
10801334000387Greenwald Surgical Company, Inc.C8120-302016-10-31

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