FDA.reportPublic FDA data

PEAK MEDICAL

Primary DI
G453332786800
Brand
PEAK MEDICAL
Company
Peak Medical Distribution Inc.
Model
3327-8680
Device description
Retrograde Valvulotomes Blade 9.5"
Published
2023-05-01
Public version status
Update
Distribution status
Not 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
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G453332786800PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Valvulotome, reusableA hand-held manual surgical instrument designed for cutting an anatomical valve or valves in situ (e.g., to slit a heart valve or to cut the valves within a vein to allow blood flow in the opposite direction). It is typically a flexible, plastic-coated metal shaft with a proximal handle and an extremely sharp cutting edge at the distal tip (e.g., the distal tip may terminate in a blade which is curved at 90 degrees to the shaft, or an assembly of several thin helicoidal blades that are rotated). 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
G4531121L0PEAK MEDICAL1121L2026-10-28
G4531121M0PEAK MEDICAL1121M2026-10-28
G4531121S0PEAK MEDICAL1121S2026-10-28
G453521954312M0PEAK MEDICAL52105-43-12M2026-10-20
G4533310960PEAK MEDICAL33-10962026-10-19
G453521053112M0PEAK MEDICAL52105-31-12M2025-10-01
G4533352105310PEAK MEDICAL335210-5312025-08-13
G4533310930PEAK MEDICAL33-10932026-08-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD903260200Surgical DirectSurgical Direct, Inc.DWS2026-10-28
00724995264819Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264826Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264833Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264840Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264857Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995265564Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995265571Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995265588Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995278977V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279004V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279042V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279059V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279066V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279080V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280093V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280826V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280871V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280895V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280901V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280918V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280925V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280987V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995281045V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995281229V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995281243V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995281250V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995281267V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995281274V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995281281V. MuellerSTERIS Deutschland GmbHDWS2026-10-27