FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925037014
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
005-5-101
Device description
OPHTHALMIC CAUTERY, FINE TIP, STERILE LOW 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
00821925000469PackageGS110In Commercial Distribution
00821925037014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925000469008219250004698219250004690821925000469
00821925037014008219250370148219250370140821925037014

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
00821925014206Gyrus ACMI1404202015-10-24
00821925014213Gyrus ACMI1404212015-10-24
00821925014237Gyrus ACMI1404232015-10-24
00821925014244Gyrus ACMI1404252015-10-24
00821925014251Gyrus ACMI1404262015-10-24
00821925014268Gyrus ACMI1404272015-10-24
00821925014299Gyrus ACMI1404342015-10-24
00821925014558Gyrus ACMI1403402015-10-24
00821925014565Gyrus ACMI1403412015-10-24
00821925014572Gyrus ACMI1404102015-10-24
00821925014589Gyrus ACMI1404112015-10-24
00821925014596Gyrus ACMI1404122015-10-24
00821925014619Gyrus ACMI1404152015-10-24
00821925014626Gyrus ACMI1404162015-10-24
00821925014640Gyrus ACMI1404182015-10-24
00821925014916Gyrus ACMI1403302015-10-24
00821925015210Gyrus ACMI1403312015-10-24
00821925015227Gyrus ACMI1403322015-10-24
00821925015234Gyrus ACMI1403332015-10-24
00821925015241Gyrus ACMI1403342015-10-24

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