FDA.reportPublic FDA data

PEAK MEDICAL

Primary DI
G453GA18540
Brand
PEAK MEDICAL
Company
Peak Medical Distribution Inc.
Model
GA1-854
Device description
"Iris Micro Dissecting Scr, 4"" (10.2 Cm), Str"
Published
2024-04-11
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
G453GA18540PrimaryHIBCC0

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
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
00190776395483MillenniumAvalign Technologies, Inc.GAD2026-07-14
00190776395575MillenniumAvalign Technologies, Inc.LRW2026-07-14
00190776395582MillenniumAvalign Technologies, Inc.LRW2026-07-14
B382SD123750Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD123760Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD123780Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD124326191140Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD209910FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD209920FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD209923FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907126105T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907247080T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907247112T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD90724711T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907249100Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907284670Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907337510Surgical DirectSurgical Direct, Inc.GAD2026-07-14
G453152901750PEAK MEDICALPeak Medical Distribution Inc.GAD2026-07-14
04059453162618Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRW2026-07-13
00198506091872ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-10
00810158211193PRINCETONPrinceton Medical Group, Inc.GAD2026-07-10
00810158219861PRINCETONPrinceton Medical Group, Inc.GAD2026-07-10
00850088713022PRINCETONPrinceton Medical Group, Inc.LRW2026-07-10
00850088713060PRINCETONPrinceton Medical Group, Inc.LRW2026-07-10
00850088713077PRINCETONPrinceton Medical Group, Inc.LRW2026-07-10
00850088713084PRINCETONPrinceton Medical Group, Inc.LRW2026-07-10
00850088713091PRINCETONPrinceton Medical Group, Inc.LRW2026-07-10
00888937033687ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033694ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033700ONETRACCoopersurgical, Inc.GAD2026-07-10