FDA.reportPublic FDA data

AEON

Primary DI
00850060791109
Brand
AEON
Company
LEXINGTON MEDICAL, INC.
Model
ASR45RS
Device description
Endoscopic Stapler 45mm Short Tip Reload 3.25mm/1.5mm
Published
2025-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GDWStaple, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDWStaple, ImplantableGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850060791116PrimaryGS10
00850060791109Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850060791116008500607911168500607911160850060791116
00850060791109008500607911098500607911090850060791109

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic manual linear cutting stapler, single-useA sterile, hand-held, manual surgical instrument intended to be used during abdominal, gynaecologic, paediatric, and thoracic endoscopic (i.e., endotherapy) surgery for the expeditious transection/resection of tissues and creation of anastomoses; it may also be used during open surgery. The device operates by a manual mechanism (e.g., trigger mechanism) whereby it cuts the tissues (e.g., colon) and simultaneously applies single or multiple linear rows of surgical staples to the resulting ends, eliminating the need for temporary clamping. The staples and cutting blade may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079881514
Device count
6
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850060791147AEONASR45PS2025-05-01
00850060791154AEONASR45PS2025-05-01
00850060791130AEONASR45WS2025-02-18
00850060791116AEONASR45RS2025-01-09
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
00851574008745AEONARBS3002018-06-01
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
10884521703827Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703834Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703841Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703858Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703797Tri-Staple 2.0Covidien LPGDW2026-07-31
10884521703810Tri-Staple 2.0Covidien LPGDW2026-07-31
16953886000033TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000040TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000057TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000064TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000071TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000088TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000095TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000101TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000330TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000347TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000354TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000408TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000415TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000422TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000439TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000446TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000453TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000460TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000477TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000484TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000491TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000514TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000521TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000569TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27