FDA.reportPublic FDA data

American Biosurgical

Primary DI
10849593024805
Brand
American Biosurgical
Company
AMC
Model
AB 6002
Catalog number
CB-AB 6002-2 (S)
Device description
Disposable Bipolar Cord Wolf to Wolf Green 12 ft
Published
2021-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00849593024815PackageGS15In Commercial Distribution
10849593024805PackageGS110In Commercial Distribution
00849593024808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849593024815008495930248158495930248150849593024815
1084959302480510849593024805
00849593024808008495930248088495930248080849593024808

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
080242300
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20849593005344LifeSyncLS-238B2022-11-21
00084959302521GoldSelect™DGE-602022-11-18
20849593005764LifeSyncLS-2292022-11-20
20849593005801LifeSyncLS-229D2022-11-20
00849593017381AMCLW-329DS120/5AT2020-06-10
00849593024860AMCLWM-341DS120/5A2021-06-30
10849593019993American Biosurgical22-7000-CCB-AB 1000-1 (S)2021-06-23
10849593020821American BiosurgicalAB 1000 CB-AB 1000-2 (S)2021-06-23
10849593024645American BiosurgicalBA520CB-AB 1000-3 (S)2021-06-23
10849593024669American BiosurgicalM2401CB-AB 1000-4 (S)2021-06-23
10849593024683American Biosurgical4530CB-AB 1000-6 (S)2021-06-23
10849593024706American Biosurgical201102CB-AB 1000-7 (S)2021-06-23
10849593024720American BiosurgicalAB 5003CB-AB 5003-2 (S)2021-06-23
10849593024744American Biosurgical99-AB5003SCB-AB 5003-4 (S)2021-06-23
10849593024768American BiosurgicalAB 5003CB-AB 5003-5 (S)2021-06-23
10849593024782American Biosurgical4130CB-AB 5003-6 (S)2021-06-23
10849593024829American BiosurgicalAB 6003CB-AB 6003-2 (S)2021-06-23
10849593024843American BiosurgicalAB 6003 CB-AB 6003-5 (S)2021-06-23
10849593019573American BiosurgicalCB-AB 1000 (S)2021-06-03
00849593019606American BiosurgicalCB-AB 5003-G-NS2021-06-03

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Primary DI, Brand, Company table
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