FDA.reportPublic FDA data

GEM BiPolar Cord

Primary DI
00844735006117
Brand
GEM BiPolar Cord
Company
SYNOVIS MICRO COMPANIES ALLIANCE, INC
Model
GEM41105-FP
Catalog number
521441105010
Device description
Electrosurgical Cords designed to conduct electrical power from the output of a high frequency generator to a BiPolar instrument.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111262000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111262000ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOPOlsen Medical2012-05-23GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844735006117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844735006117008447350061178447350061170844735006117

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA 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 reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303Medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
031284586
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00844735006230GEM BIOVER Microvascular ClampTKFV-1TKFV-12022-04-19
00844735006247GEM BIOVER Microvascular ClampTKSV-1TKSV-12022-04-19
00844735006254GEM BIOVER Microvascular ClampTKMV-1TKMV-12022-04-19
00844735006261GEM BIOVER Microvascular ClampTKLV-1TKLV-12022-04-19
00844735006278GEM BIOVER Microvascular ClampTKS-1TKS-12022-04-19
00844735006285GEM BIOVER Microvascular ClampTKM-1TKM-12022-04-19
00844735006292GEM BIOVER Microvascular ClampTKL-1TKL-12022-04-19
00844735006308GEM BIOVER Microvascular ClampTKFV-2TKFV-22022-04-19
00844735006315GEM BIOVER Microvascular ClampTKSV-2TKSV-22022-04-19
00844735006322GEM BIOVER Microvascular ClampTKMV-2TKMV-22022-04-19
00844735006339GEM BIOVER Microvascular ClampTKLV-2TKLV-22022-04-19
00844735006346GEM BIOVER Microvascular ClampTKS-2TKS-22022-04-19
00844735006353GEM BIOVER Microvascular ClampTKM-2TKM-22022-04-19
00844735006360GEM BIOVER Microvascular ClampTKL-2TKL-22022-04-19
00844735002607GEM Microvascular Anastomotic COUPLERGEM27505111001000602015-10-08
00844735002621GEM Microvascular Anastomotic COUPLERGEM27515111001500602015-10-08
00844735002645GEM Microvascular Anastomotic COUPLERGEM27525111002000602015-10-08
00844735002669GEM Microvascular Anastomotic COUPLERGEM27535111002500602015-10-08
00844735002683GEM Microvascular Anastomotic COUPLERGEM27545111003000602015-10-08
00844735002706GEM Microvascular Anastomotic COUPLERGEM27555121003500602015-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429140MillenniumAvalign Technologies, Inc.GEI2026-09-04
00840113233281BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233304BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233328BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233342BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233366BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233380BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233403BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233427BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233441BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233465BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233489BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233502BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233526BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237326BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237340BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237593BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237623BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237661BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237692BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00190776428006MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428037MillenniumAvalign Technologies, Inc.GEI2026-08-27
B4193533010Maxtown MedicalModern Surgical Instruments LLCGEI2026-08-27
ESUMARS980010SutterSutter Medizintechnik GmbHGEI2026-08-27
00190776427436MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427542MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427573MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427672MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427689MillenniumAvalign Technologies, Inc.GEI2026-08-26
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDGEI2026-08-26