FDA.reportPublic FDA data

AMERICAN BIOSURGICAL

Primary DI
30852028007162
Brand
AMERICAN BIOSURGICAL
Company
AMERICAN BIOSURGICAL, LLC
Model
AB 6003-G-NS
Catalog number
AB 6003-G-NS
Device description
Disposable, 12 foot, Bipolar, Green Cable, Wolf to Banana, Non-Sterile
Published
2017-03-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K953889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953889000AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORDAmerican Biosurgical, Inc.1995-10-18GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30852028007162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085202800716230852028007162

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, single-useA 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. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.

Sterilization Methods#

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

Regulatory Flags#

DUNS number
926239781
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration 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
10852028007007AMERICAN BIOSURGICALAB 1000-B-NSAB 1000-B-NS2017-03-17
10852028007014AMERICAN BIOSURGICALAB 1000-G-NSAB 1000-G-NS2017-03-17
10852028007021AMERICAN BIOSURGICALAB 1000-C-NSAB 1000-C-NS2017-03-17
10852028007038AMERICAN BIOSURGICALAB 5003-G-NSAB 5003-G-NS2017-03-17
10852028007106AMERICAN BIOSURGICALAB 2000 B AAB 2000 B A2017-03-17
10852028007113AMERICAN BIOSURGICALAB 2001 B AAB 2001 B A2017-03-17
10852028007120AMERICAN BIOSURGICALAB 5004 AAB 5004 A2017-03-17
10852028007137AMERICAN BIOSURGICALAB 5005 BAB 5005 B2017-03-17
10852028007144AMERICAN BIOSURGICALAB 6004 AAB 6004 A2017-03-17
10852028007151AMERICAN BIOSURGICALAB 6005 AAB 6005 A2017-03-17
10852028007168AMERICAN BIOSURGICALAB 6003 (S)AB 6003 (S)2017-03-17
10852028007175AMERICAN BIOSURGICALAB 6002(S)AB 6002(S)2018-01-05
20852028007165AMERICAN BIOSURGICALAB 6003 (S)AB 6003 (S)2017-03-17
20852028007172AMERICAN BIOSURGICALAB 6002(S)AB 6002(S)2018-01-05
00852028007000AMERICAN BIOSURGICALAB 1000-B-NSAB 1000-B-NS2017-03-17
00852028007017AMERICAN BIOSURGICALAB 1000-G-NSAB 1000-G-NS2017-03-17
00852028007024AMERICAN BIOSURGICALAB 1000-C-NSAB 1000-C-NS2017-03-17
00852028007031AMERICAN BIOSURGICALAB 5003-G-NSAB 5003-G-NS2017-03-17
00852028007048AMERICAN BIOSURGICALAB 1000(S)AB 1000(S)2017-03-17
00852028007055AMERICAN BIOSURGICALAB 1000(S)AB 1000(S)2017-03-17

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