FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925037045
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
005-5-401
Device description
SURGICAL CAUTERY, ELONGATED TIP, STERILE HIGH TEMPERATURE (10/Pk)
Published
2024-07-25
Public version status
Update
Distribution status
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
HQPUnit, Cautery, Thermal, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQPUnit, Cautery, Thermal, Battery-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121441000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121441000CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)Bovie Medical Corporation2012-07-20HQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925000490PackageGS110In Commercial Distribution
00821925037045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925000490008219250004908219250004900821925000490
00821925037045008219250370458219250370450821925037045

GMDN Terms#

Term, Definition table
TermDefinition
Electrocautery system handpieceAn electrode handpiece that functions as the holder for a detachable cautery electrode, which together become the conducting unit, providing a means of conducting an electrical current used to heat the electrode tip used during surgical intervention to burn or sear body tissue. It will typically be made of heat and electrical resistant materials and include the cables/plugs that connect to the generator. This device can be used for, e.g., to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions, e.g., the removal of warts. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
007198742
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925013964GYRUS ACMI, INC1400032015-10-24
00821925014039EVONOS GMBH & Co. Kg1400532015-10-24
00821925014060EVONOS GMBH & Co. Kg1400592015-10-24
00821925014176GYRUS ACMI, INC1400872015-10-24
00821925014190GYRUS ACMI, INC1401022015-10-24
00821925014497GYRUS ACMI, INC1401032015-10-24
00821925014534GYRUS ACMI, INC1400702015-10-24
00821925015449Gyrus ACMI1401812015-10-24
00821925015470Gyrus ACMI1401852015-10-24
00821925015487Gyrus ACMI1401862015-10-24
00821925015500GYRUS ACMI, INC1401882015-10-24
00821925016057Gyrus ACMI1401642015-10-24
00821925016064Gyrus ACMI1401652015-10-24
00821925016071Gyrus ACMI1401662015-10-24
00821925016088Gyrus ACMI1401672015-10-24
00821925016095GYRUS ACMI, INC1401682015-10-24
00821925016125Gyrus ACMI1401802015-10-24
00821925016934GYRUS ACMI, INC1401492015-10-24
00821925016965Gyrus ACMI1401622015-10-24
00821925017207GYRUS ACMI, INC1401082015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00886158106586BVIBeaver-Visitec International, Inc.HQP2025-09-10
00886158106593BVIBeaver-Visitec International, Inc.HQP2025-09-10
00886158106609BVIBeaver-Visitec International, Inc.HQP2025-08-11
00886158034247BVIBeaver-Visitec International, Inc.HQP2025-07-22
00886158034674BVIBeaver-Visitec International, Inc.HQP2025-07-22
00886158034681BVIBeaver-Visitec International, Inc.HQP2025-07-22
00886158037569BVIBeaver-Visitec International, Inc.HQP2025-07-22
00886158037576BVIBeaver-Visitec International, Inc.HQP2025-07-22
10887482175160BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177119BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177133BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177157BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177171BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177201BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177225BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177249BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177263BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177287BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177409BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177423BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177508BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
00887482177105BovieSYMMETRY SURGICAL INC.HQP2024-08-28
00887482177129BovieSYMMETRY SURGICAL INC.HQP2024-08-28
00887482177143BovieSYMMETRY SURGICAL INC.HQP2024-08-28
00887482177167BovieSYMMETRY SURGICAL INC.HQP2024-08-28
00887482177198BovieSYMMETRY SURGICAL INC.HQP2024-08-28
00887482177211BovieSYMMETRY SURGICAL INC.HQP2024-08-28
00887482177235BovieSYMMETRY SURGICAL INC.HQP2024-08-28
00887482177259BovieSYMMETRY SURGICAL INC.HQP2024-08-28
00887482177273BovieSYMMETRY SURGICAL INC.HQP2024-08-28