FDA.reportPublic FDA data

AEON

Primary DI
00851574008745
Brand
AEON
Company
LEXINGTON MEDICAL, INC.
Model
ARBS300
Device description
Retrieval Bag - Small
Published
2018-06-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180114000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180114000AEON Retrieval BagLexington Medical, Inc.2018-03-27GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851574008745PrimaryGS10
00851574008752Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851574008745008515740087458515740087450851574008745
00851574008752008515740087528515740087520851574008752

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
079881514
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850060791147AEONASR45PS2025-05-01
00850060791154AEONASR45PS2025-05-01
00850060791130AEONASR45WS2025-02-18
00850060791116AEONASR45RS2025-01-09
00850060791109AEONASR45RS2025-01-09
00850060791062AEONAEPH0602024-06-05
00850060791079AEONAEPH1602024-06-05
00850060791086AEONAEPH2602024-06-05
00850060791031AEONAEPH2602024-05-24
00850060791048AEONAEPH0602024-05-24
00850060791055AEONAEPH1602024-05-24
00851574008639AEONAEPH2602024-05-24
00851574008356AEONAEPH0602024-05-24
00851574008479AEONAEPH1602024-05-24
00851574008783AEONARBL9992018-06-01
00851574008042AEONAESC60G2024-01-01
00851574008097AEONAESR60G2024-01-01
00851574008790AEONASR60GC2024-01-01
00851574008059AEONAESR60G2024-01-01
00851574008363AEONAETH1602023-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435493MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435547MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435295MillenniumAvalign Technologies, Inc.GCJ2026-10-19
00190776435455MillenniumAvalign Technologies, Inc.GCJ2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
04548736175013OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175068OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175112OLYMPUSSONY CORPORATIONGCJ2026-10-15
00190776434922MillenniumAvalign Technologies, Inc.GCJ2026-10-14
00190776434823MillenniumAvalign Technologies, Inc.GCJ2026-10-13
00190776434854MillenniumAvalign Technologies, Inc.GCJ2026-10-13
B382SD56300680Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
B382SD563006820Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
00190776434250MillenniumAvalign Technologies, Inc.GCJ2026-10-09
00848657078481AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00848657078498AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00190776433697MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433703MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433710MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433727MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433338MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433345MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433031MillenniumAvalign Technologies, Inc.GCJ2026-10-01
00190776433079MillenniumAvalign Technologies, Inc.GCJ2026-10-01