FDA.reportPublic FDA data

PEAK MEDICAL

Primary DI
G453FF80810
Brand
PEAK MEDICAL
Company
Peak Medical Distribution Inc.
Model
FF8-081
Device description
"Mills Circumflex Scr, W/ 1.0 Mm Ball Tip, 125° Ang, 7 1/4"" (18.5 Cm)"
Published
2024-04-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GADRetractor
LRWScissors, General, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G453FF80810PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
G4533352003290PEAK MEDICAL3352003-292026-01-05
G4533353003310PEAK MEDICAL3353003-312026-01-05
G453333553810PEAK MEDICAL3335-53812026-01-02
G453CD351170PEAK MEDICALCD3-51172025-12-07
G453CD433180PEAK MEDICALCD4-33182025-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841536147810ThompsonThompson Surgical Instruments, Inc.GAD2026-05-27
00846159039702SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039719SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039726SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039733SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039740SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039757SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039764SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039771SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
G425050183SCD0My MedicalMy Medical Store LLCLRW2026-05-04
G453BH72800PEAK MEDICALPeak Medical Distribution Inc.GAD2026-03-30
G425050933SC0My MedicalMy Medical Store LLCLRW2026-03-27
07640332476321SCARLET AL-T INSTRUMENTATIONSpineArt SAGAD2025-11-10
07640375234681PERLA ® TL MISSpineArt SAGAD2025-11-10
07640375234698PERLA ® TL MISSpineArt SAGAD2025-11-10
07640375234704PERLA ® TL MISSpineArt SAGAD2025-11-10
07640375234711PERLA ® TL MISSpineArt SAGAD2025-11-10
G453CA306140PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-28
G453CA303160PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21
G453CA331700PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21
G453CA350670PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21
G453CA351670PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21
G453CA357670PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21
G453CA413680PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21
G453CA433680PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21
G453CA433700PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21
G453CA435700PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21
G453CA455660PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21
G453CA463680PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21
G453CA467170PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21