FDA.report

PEAK MEDICAL

Primary DI
G453FJ23310
Brand
PEAK MEDICAL
Company
Peak Medical Distribution Inc.
Model
FJ2-331
Device description
Yasargil Mic Bynt Scr, Flat Bynt Hndl, Cvd, Vannas Bld, 9" (23.0 Cm)
Published
2024-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GADRetractor
LRWScissors, General, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G453FJ23310PrimaryHIBCC0

GMDN Terms

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
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 DIBrandModelCatalogPublished
G453230117BCL0PEAK MEDICAL23-0117BC-L2026-03-23
G453230117BCR0PEAK MEDICAL23-0117BC-R2026-03-23
G453CFK1000PEAK MEDICALCFK-1002026-03-23
G453FA06160PEAK MEDICALFA0-6162026-03-19
G453AR130PEAK MEDICALAR-132026-03-11
G453PM11812CH1PEAK MEDICALPM11-812-CH2026-03-10
G453PM11815CH0PEAK MEDICALPM11-815-CH2026-03-10
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
G453CD455160PEAK MEDICALCD4-55162025-12-07
G453CD467140PEAK MEDICALCD4-67142025-12-07
G453335243001H0PEAK MEDICAL3352430-01H2025-08-20
G453335243002H0PEAK MEDICAL3352430-02H2025-08-20
G453335243003H0PEAK MEDICAL3352430-03H2025-08-20
G4533352105310PEAK MEDICAL335210-5312025-08-13
G453PM57246210PEAK MEDICALPM57246-212025-07-29

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