FDA.reportPublic FDA data

AMERICAN BIOSURGICAL

Primary DI
00852028007093
Brand
AMERICAN BIOSURGICAL
Company
AMERICAN BIOSURGICAL, LLC
Model
AB 5003 (S)
Catalog number
AB 5003 (S)
Device description
Monopolar Cable, 10', Right Angle Socket, Disposable, Green, 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
Sterile
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
K971540000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971540000AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR CABLE/CORDAmerican Biosurgical, Inc.1997-08-14GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852028007093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852028007093008520280070938520280070930852028007093

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
00197998302718Solventum™Solventum US LLCGEI2026-09-25
00724995269586Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269951Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269968Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00190776432300MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432317MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432324MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432430MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432447MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432454MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776431457MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432041MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432195MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432201MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776431181MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431198MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431204MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431211MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431228MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431235MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431242MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431259MillenniumAvalign Technologies, Inc.GEI2026-09-21
10840113236852BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236890BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236937BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237040BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237064BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237101BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237118BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237132BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21