FDA.reportPublic FDA data

AMERICAN BIOSURGICAL

Primary DI
00852028007024
Brand
AMERICAN BIOSURGICAL
Company
AMERICAN BIOSURGICAL, LLC
Model
AB 1000-C-NS
Catalog number
AB 1000-C-NS
Device description
"Bipolar Cable, 12"" Disposable, Clear, Non-sterile, ea"
Published
2017-03-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
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
00852028007024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852028007024008520280070248520280070240852028007024

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
30852028007162AMERICAN BIOSURGICALAB 6003-G-NSAB 6003-G-NS2017-03-17
00852028007000AMERICAN BIOSURGICALAB 1000-B-NSAB 1000-B-NS2017-03-17
00852028007017AMERICAN BIOSURGICALAB 1000-G-NSAB 1000-G-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
00190776402143MillenniumAvalign Technologies, Inc.GEI2026-07-19
00198506092756ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105004DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105059DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105066DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105073DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020106827DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020107626DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020107633DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110565INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110640FootswitchJeisys Medical Inc.GEI2026-07-16