FDA.reportPublic FDA data

A&E Medical / Disposable Suction Coagulator

Primary DI
10841291104957
Brand
A&E Medical / Disposable Suction Coagulator
Company
A & E MEDICAL CORPORATION
Model
050-080
Device description
Suction Coagulator, 1 per pouch
Published
2016-11-23
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
K881413000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K881413000ELECTRO-CAUTERY SUCTION TUBEAlto Development Corp.1988-04-21GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20841291104954PackageGS110In Commercial Distribution
10841291104957PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084129110495420841291104954
1084129110495710841291104957

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, monopolar, single-useA rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device intended to be used in a sterile condition.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429140MillenniumAvalign Technologies, Inc.GEI2026-09-04
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00840113233304BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233328BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233342BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233366BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233380BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233403BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233427BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233441BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233465BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233489BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233502BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233526BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237326BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237340BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237593BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237623BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237661BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237692BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00190776428006MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428037MillenniumAvalign Technologies, Inc.GEI2026-08-27
B4193533010Maxtown MedicalModern Surgical Instruments LLCGEI2026-08-27
ESUMARS980010SutterSutter Medizintechnik GmbHGEI2026-08-27
00190776427436MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427542MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427573MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427672MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427689MillenniumAvalign Technologies, Inc.GEI2026-08-26
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDGEI2026-08-26