FDA.reportPublic FDA data

Greenwald Surgical Company, Inc.

Primary DI
10801334001544
Brand
Greenwald Surgical Company, Inc.
Company
GRACE MANUFACTURING, INC.
Model
77000-07
Catalog number
M25H
Device description
Plug that fits Birtcher Hyfrecator, National (Statham) Electricator
Published
2016-09-23
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
FBJCord, Electric For Transurethral Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBJCord, Electric For Transurethral Surgical InstrumentGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801334001544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080133400154410801334001544

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reprocessedA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a single-use device previously used that has been reprocessed for an additional single-use patient application.

Sterilization Methods#

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

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
10801334012830Greenwald Surgical Company, Inc.GRACE MANUFACTURING, INC.FBJ2017-07-21
10801334013967Greenwald Surgical Company, Inc.GRACE MANUFACTURING, INC.FBJ2016-09-30
10801334001278Greenwald Surgical Company, Inc.GRACE MANUFACTURING, INC.FBJ2016-09-23
10801334005726Greenwald Surgical Company, Inc.GRACE MANUFACTURING, INC.FBJ2016-09-23
10801334005740Greenwald Surgical Company, Inc.GRACE MANUFACTURING, INC.FBJ2016-09-23
10801334005962Greenwald Surgical Company, Inc.GRACE MANUFACTURING, INC.FBJ2016-09-23
10801334009977Greenwald Surgical Company, Inc.GRACE MANUFACTURING, INC.FBJ2016-09-23
10801334011703Greenwald Surgical Company, Inc.GRACE MANUFACTURING, INC.FBJ2016-09-23