FDA.reportPublic FDA data

PEAK MEDICAL

Primary DI
G4533352505380
Brand
PEAK MEDICAL
Company
Peak Medical Distribution Inc.
Model
335250538
Device description
ENDO CABOT NEEDLE HOLDER LAPAROSCOPIC STRAIGHT T/C NEEDLE HOLDER ACCORDING TO SEMM STAINLESS STEEL SHAFT, SCISSOR STYLE RING HANDEL W / SPRING
Published
2024-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GCILaryngoscope, Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCILaryngoscope, EndoscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G4533352505380PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic tissue manipulation forceps, reusableA rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. 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
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
G4533352003290PEAK MEDICAL3352003-292026-01-05
G4533353003310PEAK MEDICAL3353003-312026-01-05
G453333553810PEAK MEDICAL3335-53812026-01-02
G453CD351170PEAK MEDICALCD3-51172025-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.GCI2026-04-30
10850048763194Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763200Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763217Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763224Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763231Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763248Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763255Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763262Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763279Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763286Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763309Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763354Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763613Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763620Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763637Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763651Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10884523000948Endo Catch IICovidien LPGCI2016-09-24
10884523000955Endo Catch GoldCovidien LPGCI2016-09-24
20884523000945Endo Catch IICovidien LPGCI2016-09-24
20884523000952Endo Catch GoldCovidien LPGCI2016-09-24
30884521164820SurgiSleeveCovidien LPGCI2016-09-24
30884521164837SurgiSleeveCovidien LPGCI2016-09-24
20884521164816SurgiSleeveCovidien LPGCI2016-09-24