FDA.reportPublic FDA data

A&E Medical / Disposable Laparoscopic Cords

Primary DI
10841291105114
Brand
A&E Medical / Disposable Laparoscopic Cords
Company
A & E MEDICAL CORPORATION
Model
050-307
Device description
Disposable Laparoscopic Cords, 1 per pouch
Published
2016-12-01
Public version status
Update
Distribution status
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
K930528000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930528000A&E MEDICAL ELECTROSURGICAL CONNECTING CORDSAlto Development Corp.1993-05-17GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20841291105111PackageGS150In Commercial Distribution
10841291105114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084129110511120841291105111
1084129110511410841291105114

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.

Regulatory Flags#

DUNS number
173770868
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841291105305Myo/Wire021-0112016-03-21
08718627410004MYO/Wire® Ultra-Thin Temporary Pacing Wires AU0101022015-11-05
08718627410028MYO/Wire® Ultra-Thin Temporary Pacing Wires BM1804ABB2015-11-10
08718627410042MYO/Wire® Ultra-Thin Temporary Pacing Wires BM1804ABBN2015-11-10
08718627410066MYO/Wire® Ultra-Thin Temporary Pacing Wires BM2004ABB2015-11-10
08718627410080MYO/Wire® Ultra-Thin Temporary Pacing Wires BM2004ABBD2015-11-10
08718627410103MYO/Wire® Ultra-Thin Temporary Pacing Wires BM2008ABBSN2015-11-10
08718627410127MYO/Wire® Ultra-Thin Temporary Pacing Wires BM2504ABB2015-11-10
08718627410141MYO/Wire® Ultra-Thin Temporary Pacing Wires BM2504ABBD2015-11-10
08718627410165MYO/Wire® Ultra-Thin Temporary Pacing Wires BM2504AWWD2015-11-10
08718627410189MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604ABB2015-11-10
08718627410226MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604ABBDS2015-11-10
08718627410264MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604ABBSTR2015-11-10
08718627410288MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604ABW2015-11-10
08718627410301MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604ACBBGSTR2015-11-10
08718627410325MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604ACWWStr2015-11-10
08718627410349MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604PBB2015-11-10
08718627410363MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604PWWMSTR2015-11-10
08718627410387MYO/Wire® Ultra-Thin Temporary Pacing Wires BM608-12ABBG2015-11-05
08718627410400MYO/Wire® Ultra-Thin Temporary Pacing Wires BM608-8ACBB2015-11-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190776432430MillenniumAvalign Technologies, Inc.GEI2026-09-24
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00190776431457MillenniumAvalign Technologies, Inc.GEI2026-09-22
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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