FDA.reportPublic FDA data

AMERICAN BIOSURGICAL

Primary DI
00852028007277
Brand
AMERICAN BIOSURGICAL
Company
AMERICAN BIOSURGICAL, LLC
Model
AB 0503 (S)
Catalog number
AB 0503 (S)
Device description
"Bipolar Cable, 12"" Disposable, Blue, Sterile Inner Pack"
Published
2018-04-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00852028007277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852028007277008520280072778520280072770852028007277

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

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506092930ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506092947ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506093234ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
04250418748346Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
04250418753722Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
08800020100481POTENZA TipJeisys Medical Inc.GEI2026-07-21
08800020101754POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101761POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101778POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020110541INTRAcel PremiumJeisys Medical Inc.GEI2026-07-21
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