FDA.report

Accu-Temp®

Primary DI
30886158010259
Brand
Accu-Temp®
Company
BEAVER-VISITEC INTERNATIONAL, INC.
Model
8441500
Device description
High 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

Related Records

Contact Domains

Product Codes

CodeName
HQPUnit, cautery, thermal, battery-powered

Product Code Classifications

CodeDeviceSpecialtyClass
HQPUnit, Cautery, Thermal, Battery-PoweredOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30886158010259PrimaryGS10
00886158010258Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3088615801025930886158010259
00886158010258008861580102588861580102580886158010258

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place.

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
+1(866)906-8080customersupport@beaver-visitec
+1(866)906-8080customersupport@beaver-visitec.com
+1(866)906-8080customersupport@bvimedical.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

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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 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
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M220P2121005Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.HQP2017-02-13
50885380001411CARDINAL HEALTHCardinal Health 200, LLCHQP2016-12-29