FDA.reportPublic FDA data

Accu-Temp®

Primary DI
30886158010242
Brand
Accu-Temp®
Company
BEAVER-VISITEC INTERNATIONAL, INC.
Model
8441000
Device description
Low Temperature Cautery
Published
2016-09-19
Public version status
Update
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
30886158010242PrimaryGS10
00886158010241Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3088615801024230886158010242
00886158010241008861580102418861580102410886158010241

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(866)906-8080customersupport@beaver-visitec
+1(866)906-8080customersupport@beaver-visitec.com

Regulatory Flags#

DUNS number
001406024
Device count
10
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886158106609BVIOME6000UOME6000U2025-08-11
00886158034247BVIFS6000FS60002025-07-22
00886158034674BVIELP19SU1ELP19SU12025-07-22
00886158034681BVIELP19CU1ELP19CU12025-07-22
00886158037569BVIFS6001FS60012025-07-22
00886158037576BVIOME6001UOME60012025-07-22
30886158032121CustomEyes®58001721580017212024-07-01
30886158032428CustomEyes®58001713580017132024-07-01
30886158032435CustomEyes®58001764580017642024-07-01
30886158032442CustomEyes®58001711580017112024-07-01
30886158032473CustomEyes®58001706580017062024-07-01
30886158032480CustomEyes®58001737580017372024-07-01
30886158032497CustomEyes®58001753580017532024-07-01
30886158032787CustomEyes®58001809580018092024-07-01
30886158032800CustomEyes®58001775580017752024-07-01
30886158032886CustomEyes®58001774580017742024-07-01
30886158032893CustomEyes®58001825580018252024-07-01
30886158032985CustomEyes®58001836580018362024-07-01
30886158033166CustomEyes®58001865580018652024-07-01
30886158033180CustomEyes®58001818580018182024-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00887482177297BovieSYMMETRY SURGICAL INC.HQP2024-08-28
00887482177419BovieSYMMETRY SURGICAL INC.HQP2024-08-28
00887482177433BovieSYMMETRY SURGICAL INC.HQP2024-08-28
00887482177518BovieSYMMETRY SURGICAL INC.HQP2024-08-28
00821925000469Gyrus ACMIGyrus Acmi, Inc.HQP2024-07-25
00821925000490Gyrus ACMIGyrus Acmi, Inc.HQP2024-07-25
00886158010180Accu-temp®Beaver-Visitec International, Inc.HQP2022-01-19
00886158010197Accu-temp®Beaver-Visitec International, Inc.HQP2022-01-19
00886158010234Accu-tempBeaver-Visitec International, Inc.HQP2022-01-19
10385640053706SUMMIT MEDICALSUMMIT MEDICAL, INC.HQP2021-04-15
00385640053693SUMMIT MEDICALSUMMIT MEDICAL, INC.HQP2021-03-10
00607151011895BovieBOVIE MEDICAL CORPORATIONHQP2020-03-12
M220P2120505Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.HQP2017-02-13
M220P2121005Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.HQP2017-02-13
50885380001411CARDINAL HEALTHCardinal Health 200, LLCHQP2016-12-29