FDA.reportPublic FDA data

SUMMIT MEDICAL

Primary DI
10385640053706
Brand
SUMMIT MEDICAL
Company
SUMMIT MEDICAL, INC.
Model
20-HM-2000
Published
2021-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
10385640053706PackageGS110In Commercial Distribution
00385640053709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038564005370610385640053706
00385640053709003856400537093856400537090385640053709

GMDN Terms#

Term, Definition table
TermDefinition
Electrocautery system, battery-poweredAn assembly of battery-powered devices designed to regulate an electrical current used to heat the electrode tip or wire loop of a cutting instrument intended to burn or sear body tissues during surgery. It is typically used to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions (e.g., removal of warts, removal of gastrointestinal polyps via an appropriate endoscope), or to occlude fallopian tubes during sterilization procedures. It typically consists of a generator, a handpiece, and electrodes. Unlike electrosurgical diathermy, electrocautery does not involve electrical current passing through the patient.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
965484699
Device count
1
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00385640091183INSTRUSAFEIN-2020-75582026-03-24
00385640091190INSTRUSAFEIN-3030-02542026-03-24
00385640091206INSTRUSAFEIN-3030-02532026-03-24
00385640091152INSTRUSAFEIN-2020-76872026-03-23
00385640091169INSTRUSAFEIN-2020-77092026-03-23
00385640091176INSTRUSAFEIN-2020-77212026-03-23
00385640091114INSTRUSAFEIN-2020-75572026-03-20
00385640091121INSTRUSAFEIN-2020-75562026-03-20
00385640091138INSTRUSAFEIN-2020-76112026-03-20
00385640091145INSTRUSAFEIN-2020-75882026-03-20
00385640090872INSTRUSAFEIN-2300-10-EN-1012026-03-19
00385640090889INSTRUSAFEIN-2300-10-EN-1022026-03-19
00385640090896INSTRUSAFEIN-2300-10-EN-1032026-03-19
00385640090902INSTRUSAFEIN-2300-10-EN-1042026-03-19
00385640090919INSTRUSAFEIN-2300-10-EN-1052026-03-19
00385640090926INSTRUSAFEIN-2300-10-EN-1062026-03-19
00385640090933INSTRUSAFEIN-2300-10-EN-1072026-03-19
00385640090940INSTRUSAFEIN-2300-10-EN-1082026-03-19
00385640090957INSTRUSAFEIN-2300-10-EN-1092026-03-19
00385640090964INSTRUSAFEIN-2300-10-EN-1102026-03-19

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
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
50885380001435CARDINAL HEALTHCardinal Health 200, LLCHQP2016-12-29