FDA.reportPublic FDA data

PEAK MEDICAL

Primary DI
G45333551118BCAL0
Brand
PEAK MEDICAL
Company
Peak Medical Distribution Inc.
Model
3355-1118BC-AL
Device description
Instrument tray for suture, reusable
Published
2023-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G45333551118BCAL0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. 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
07613327602241NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602296NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602302NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602326NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602418NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663518NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663525NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663532NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663549NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663556NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663563NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
18257200028177PHOENIX SFSOrthofix US LLCFSM2026-07-17
18257200028207PHOENIX SFSOrthofix US LLCFSM2026-07-17
18257200028917FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028924FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028931FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028948FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028955FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028979FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028986FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028993FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029006FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029013FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029020FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029280FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029846FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029853FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029860FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029877FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029884FIREBIRD SFSOrthofix US LLCFSM2026-07-17