FDA.reportPublic FDA data

Bovie

Primary DI
10840113233547
Brand
Bovie
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
AA05X
Device description
Cautery High Temperature 2" Extended Shaft Loop Tip
Published
2026-09-21
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQPUnit, Cautery, Thermal, Battery-Powered

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840113233547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084011323354710840113233547

GMDN Terms#

Term, Definition table
TermDefinition
Electrocautery system generator, battery-poweredA battery-powered device that produces and delivers a regulated electrical current used to heat the electrode tip or wire loop of a cutting instrument used during surgical intervention to burn or sear body tissue. It is used to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions, e.g., the removal of warts, the removal of gastrointestinal polyps via an appropriate endoscope, or to occlude fallopian tubes during sterilization procedures. It will typically contain electronic circuits and have a built-in thermocoupler to help control the temperature at the electrode. This is not an electrosurgical diathermy system.

Contacts#

Phone, Email table
PhoneEmail
8883647004customerservice@aspensurgical.com

Regulatory Flags#

DUNS number
027680821
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840113232908BovieAA002026-09-21
10840113232922BovieAA00X2026-09-21
10840113232946BovieAA012026-09-21
10840113232960BovieAA01X2026-09-21
10840113232984BovieAA022026-09-21
10840113233004BovieAA032026-09-21
10840113233028BovieAA03X2026-09-21
10840113233042BovieAA042026-09-21
10840113233066BovieAA04X2026-09-21
10840113233080BovieAA052026-09-21
10840113233165BovieAA212026-09-21
10840113233189BovieAA21X2026-09-21
10840113233264BovieAA902026-09-21
10840113234407BovieES232026-09-21
10840113234414BovieES22-82026-09-21
10840113236838BovieES032026-09-21
10840113236845BovieES022026-09-21
10840113236852BovieES02T2026-09-21
10840113236876BovieES012026-09-21
10840113236883BovieES222026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840113232908BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113232922BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113232946BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113232960BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113232984BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113233004BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113233028BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113233042BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113233066BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113233080BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113233165BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113233189BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113233264BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
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