FDA.reportPublic FDA data

PEAK MEDICAL

Primary DI
G4533310930
Brand
PEAK MEDICAL
Company
Peak Medical Distribution Inc.
Model
33-1093
Device description
Penfield hand held dissector, 7.5" long (19cm), blunt tip, Stainless Steel
Published
2026-08-27
Public version status
Update
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
GDIDissector, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDIDissector, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G4533310930PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078393632
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
false
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
G453521954312M0PEAK MEDICAL52105-43-12M2026-10-20
G4533310960PEAK MEDICAL33-10962026-10-19
G453521053112M0PEAK MEDICAL52105-31-12M2025-10-01
G4533352105310PEAK MEDICAL335210-5312025-08-13
G453FCE2004SI0PEAK MEDICALFCE-2004-SI2026-08-25
G453FCE2005SI0PEAK MEDICALFCE-2005-SI2026-08-25
G453FCE2006SI0PEAK MEDICALFCE-2006-SI2026-08-25
G453FCE2007SI0PEAK MEDICALFCE-2007-SI2026-08-25
G453333630140PEAK MEDICAL3336-30142026-08-14
G4533315010BC0PEAK MEDICAL33-15010-BC2026-08-07
G4533315012BC0PEAK MEDICAL33-15012-BC2026-08-07
G453PM1840W0PEAK MEDICALPM-1840W2026-07-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435363MillenniumAvalign Technologies, Inc.GDI2026-10-19
00190776433765MillenniumAvalign Technologies, Inc.GDI2026-10-08
00190776433758MillenniumAvalign Technologies, Inc.GDI2026-10-07
G141530254210Carnegie Surgical LLCCarnegie Surgical LLCGDI2026-10-07
G14155805410Carnegie Surgical LLCCarnegie Surgical LLCGDI2026-10-07
G14155805420Carnegie Surgical LLCCarnegie Surgical LLCGDI2026-10-07
G14167216050Carnegie Surgical LLCCarnegie Surgical LLCGDI2026-10-07
G1415530254210Carnegie Surgical LLCCarnegie Surgical LLCGDI2026-09-30
00190776432461MillenniumAvalign Technologies, Inc.GDI2026-09-24
00190776419110MillenniumAvalign Technologies, Inc.GDI2026-08-23
00840217910286Wiggins MedicalEBNER MEDICAL, LLCGDI2026-08-13
00190776424367MillenniumAvalign Technologies, Inc.GDI2026-08-07
00190776408626MillenniumAvalign Technologies, Inc.GDI2026-08-03
B382SD914709040Surgical DirectSurgical Direct, Inc.GDI2026-07-29
00810068850765Biocore9 Acetabular Bearing SystemBiocore9, LLCGDI2026-06-26
07898789390121ENDOFOREHEAD DISSECTOR 5MM ANGLEDTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-06-09
07898789390138ENDOFOREHEAD DISSECTOR WITH SUCTION STRAIGHT 30CMTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-06-09
07898789390039GRAIVIER MID-FACE DISSECTOR LEFTTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390046GRAIVIER MID-FACE DISSECTOR RIGHTTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390060FRONTO MARTINS 2 ENDOFOREHEAD DISSECTORTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
00196449034512Anatomic Access LLIFTyber Medical, LLCGDI2025-10-22
00840217909570Wiggins MedicalEBNER MEDICAL, LLCGDI2025-04-08
00840217909587Wiggins MedicalEBNER MEDICAL, LLCGDI2025-04-08
00840217909358Ace Medical CompanyEBNER MEDICAL, LLCGDI2024-12-09
00840217909365Ace Medical CompanyEBNER MEDICAL, LLCGDI2024-12-09
00840217909372Ace Medical CompanyEBNER MEDICAL, LLCGDI2024-12-09
00840217909389Ace Medical CompanyEBNER MEDICAL, LLCGDI2024-12-09
10840199523402DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533302DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533319 DissectorKOROS U.S.A., INC.GDI2024-02-06