FDA.reportPublic FDA data

Greenwald Surgical Company, Inc.

Primary DI
10801334011901
Brand
Greenwald Surgical Company, Inc.
Company
GRACE MANUFACTURING, INC.
Model
51200-00
Catalog number
U530
Device description
Stamey Dorsal Vein Apical Retractor. Stainless steel throughout. Handle flange provides secure control and cephaled retraction. Retractor blades provide a wide space on both sides of the dorsal vein complex for placing a controlling suture.
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
FGNRetractor, Non-Self-Retaining

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGNRetractor, Non-Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801334011901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080133401190110801334011901

GMDN Terms#

Term, Definition table
TermDefinition
Vessel retractorA hand-held, surgical instrument used for separating/drawing aside vascular structures to permit examination or intervention during a surgical procedure. It is typically a shaft-like instrument with an inwardly curved, saddle hook at the distal end and a handle at the proximal end. It may also be known as a vein retractor. It is made of high-grade stainless steel. This is a reusable device.

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
10801334000134Greenwald Surgical Company, Inc.53230-06U3232016-10-31

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