FDA.reportPublic FDA data

PEAK MEDICAL

Primary DI
G453335255540010
Brand
PEAK MEDICAL
Company
Peak Medical Distribution Inc.
Model
3352555-40-01
Device description
Type 1 Replacement Insulated Scissor and Biopsy Cup Handle w/ RF Post.
Published
2025-01-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G453335255540010PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078393632
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G453152901750PEAK MEDICAL15-29-1752026-07-14
G4533306290PEAK MEDICAL33-06292026-06-24
G4533312250PEAK MEDICAL33-12252026-06-08
G453PM1580030BC0PEAK MEDICALPM15800-30BC2026-06-08
G4533312BT0PEAK MEDICAL33-12BT2026-06-03
G4533352797GM8M50PEAK MEDICAL3352-797GM8M52026-05-27
G453332414200PEAK MEDICAL3324-14-202026-05-08
G45313110753150PEAK MEDICAL131-1075-3152026-05-06
G453332321055BC010PEAK MEDICAL33-23-21055BC-012026-05-06
G453BH72800PEAK MEDICALBH7-2802026-03-30
G453230117BCL0PEAK MEDICAL23-0117BC-L2026-03-23
G453230117BCR0PEAK MEDICAL23-0117BC-R2026-03-23
G453CFK1000PEAK MEDICALCFK-1002026-03-23
G453333481030PEAK MEDICAL3324-81032024-04-11
G453FA06160PEAK MEDICALFA0-6162026-03-19
G453AR130PEAK MEDICALAR-132026-03-11
G453PM11812CH1PEAK MEDICALPM11-812-CH2026-03-10
G453PM11815CH0PEAK MEDICALPM11-815-CH2026-03-10
G4532420530BC0PEAK MEDICAL24205-30-BC2026-02-24
G453335200112L0PEAK MEDICAL3352001-12L2026-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506092930ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506092947ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506093234ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
04250418748346Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
04250418753722Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
08800020100481POTENZA TipJeisys Medical Inc.GEI2026-07-21
08800020101754POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101761POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101778POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020110541INTRAcel PremiumJeisys Medical Inc.GEI2026-07-21
00190776402143MillenniumAvalign Technologies, Inc.GEI2026-07-19
00198506092756ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16