FDA.reportPublic FDA data

AccuMedx

Primary DI
00850059707814
Brand
AccuMedx
Company
Accumedx, LLC
Model
AMSR10-200
Device description
200ml Detachable Retrieval Bag 10mm x 330mm
Published
2024-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850059707821PackageGS110In Commercial Distribution
00850059707838PackageGS110In Commercial Distribution
00850059707814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850059707821008500597078218500597078210850059707821
00850059707838008500597078388500597078380850059707838
00850059707814008500597078148500597078140850059707814

GMDN Terms#

Term, Definition table
TermDefinition
Tissue extraction bagAn impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
096236324
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850059707548AccuMedxAMMSC-332024-01-23
00850059707579AccuMedxAMMSS-332024-01-23
00850059707005AccuMedxAMVN-1202024-01-23
00850059707012AccuMedxAMVN-1502024-01-23
00850059707067AccuMedxAM5-1002024-01-23
00850059707098AccuMedxAM5-1502024-01-23
00850059707128AccuMedxAM12-1002024-01-23
00850059707159AccuMedxAM12-1502024-01-23
00850059707180AccuMedxAM15-1002024-01-23
00850059707210AccuMedxAM15-1502024-01-23
00850059707241AccuMedxAMO5-1002024-01-23
00850059707272AccuMedxAMO5-1502024-01-23
00850059707302AccuMedxAMO12-1002024-01-23
00850059707333AccuMedxAMO12-1502024-01-23
00850059707364AccuMedxAMO15-1002024-01-23
00850059707395AccuMedxAMO15-1502024-01-23
00850059707425AccuMedxAMSI-332024-01-23
00850059707456AccuMedxAMSI-452024-01-23
00850059707487AccuMedxAMSI-33S2024-01-23
00850059707517AccuMedxAMSI-45S2024-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995268312Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268329Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268336Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268343Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268350Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268374Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268381Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268398Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268404Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268411Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268428Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268435Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268442Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268459Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268466Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268473Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268480Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268497Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268503Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269517Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269531Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269548Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269555Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269562Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269579Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269593Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
04995047072416CuratOREIZO CORPORATIONGCJ2026-09-25
00190776432348MillenniumAvalign Technologies, Inc.GCJ2026-09-24
00190776432386MillenniumAvalign Technologies, Inc.GCJ2026-09-24
00190776432416MillenniumAvalign Technologies, Inc.GCJ2026-09-24