AEON

GUDID 00851574008660

Endoscopic Stapler 60mm Reload 3.25mm/1.5mm

LEXINGTON MEDICAL, INC.

Endoscopic manual linear cutting stapler, single-use

• Primary Device ID: 00851574008660
• NIH Device Record Key: 50bc506d-8af5-437c-afad-92a5027a9e00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AEON
• Version Model Number: AESR60R
• Company DUNS: 079881514
• Company Name: LEXINGTON MEDICAL, INC.
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851574008660 [Primary]
GS1	00851574008677 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171589

FDA Product Code

• GDW: Staple, Implantable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-20

On-Brand Devices [AEON]

• 00851574008868: Endoscopic Stapler 45mm Reload 4.0mm/1.8mm
• 00851574008820: Endoscopic Stapler 60mm Reload 2.5mm/1.0mm
• 00851574008806: Endoscopic Stapler 45mm Reload 3.25mm/1.5mm
• 00851574008783: Retrieval Bag - Large
• 00851574008745: Retrieval Bag - Small
• 00851574008721: Endoscopic Stapler 60mm Reload 4.0mm/1.8mm
• 00851574008707: Endoscopic Stapler 60mm Reload 5.0mm/2.2mm
• 00851574008684: Endoscopic Stapler 45mm Reload 2.5mm/1.0mm
• 00851574008660: Endoscopic Stapler 60mm Reload 3.25mm/1.5mm
• 00851574008080: Endoscopic Stapler 60mm Reload Purple
• 00851574008066: Endoscopic Stapler 60mm Reload Tan
• 00851574008028: Endoscopic Stapler Handle - Long
• 00851574008004: Endoscopic Stapler Handle - Medium
• 00851574008943: Endoscopic Stapler 45mm Curved Tip Reload 2.0mm/0.75mm
• 00851574008929: Endoscopic Stapler 45mm Curved Tip Reload 2.5mm/1.0mm
• 00851574008844: Endoscopic Stapler 45mm Reload 2.0mm/0.75mm
• 00851574008981: Endoscopic Stapler 45mm Curved Tip Reload 4.0mm/1.8mm
• 00851574008967: Endoscopic Stapler 45mm Curved Tip Reload 3.25mm/1.5mm
• 00851574008905: Endoscopic Stapler 60mm Reload 2.5mm/1.0mm
• 00851574008882: Endoscopic Stapler 45mm Reload 2.5mm/1.0mm
• 00851574008110: Endoscopic Stapler 45mm Curved Tip Reload 2.5mm/1.0mm
• 00851574008134: Endoscopic Stapler Handle - Short
• 00851574008271: Endoscopic Stapler 60mm Curved Tip Reload 3.25mm/1.5mm
• 00851574008257: Endoscopic Stapler 60mm Curved Tip Reload 2.5mm/1.0mm
• 00851574008172: Endoscopic Stapler 60mm Curved Tip Reload 4.0mm/1.8mm
• 00851574008233: Endoscopic Stapler 60mm Short Tip Reload 2.5mm/1.0mm
• 00851574008219: Endoscopic Stapler 60mm Short Tip Reload 3.25mm/1.5mm
• 00851574008196: Endoscopic Stapler 60mm Short Tip Reload 4.0mm/1.8mm
• 00851574008318: Endoscopic Stapler 30mm Curved Tip Reload 2.5mm/1.0mm
• 00851574008141: Endoscopic Stapler 30mm Reload 2.5mm/1.0mm
• 00851574008332: Endoscopic Stapler 30mm Short Tip Reload 2.5mm/1.0mm
• 00851574008592: Endoscopic Stapler 30mm Curved Tip Reload 3.25mm/1.5mm
• 00851574008578: Endoscopic Stapler 30mm Short Tip Reload 3.25mm/1.5mm
• 00851574008554: Endoscopic Stapler 30mm Reload 4.0mm/1.8mm
• 00851574008530: Endoscopic Stapler 30mm Curved Tip Reload 4.0mm/1.8mm
• 00851574008516: Endoscopic Stapler 30mm Short Tip Reload 4.0mm/1.8mm
• 00851574008455: Endoscopic Stapler 30mm Reload 3.25mm/1.5mm
• 00851574008431: Endoscopic Stapler 30mm Reload 2.0mm/0.75mm
• 00851574008417: Endoscopic Stapler 30mm Curved Tip Reload 2.0mm/0.75mm
• 00851574008394: Endoscopic Stapler 30mm Short Tip Reload 2.0mm/0.75mm
• 00851574008646: Endoscopic Stapler 45mm 5.0mm/2.2mm Black
• 00851574008752: AEON Endoscopic Stapler 45mm Curved Tip Reload- 5.0mm/2.2mm
• 00851574008653: Endoscopic Stapler Handle Plus Short
• 00851574008370: Endoscopic Stapler Handle Plus Long
• 00851574008486: Endoscopic Stapler Plus Handle Medium
• 00851574008059: Endoscopic Stapler Reload 60mm 2.00mm/0.75mm Grey
• 00851574008790: Endostapler 60mm Curved Reload 2.0nn/0.75mm
• 00851574008479: Endoscopic Powered Stapler - Medium
• 00851574008356: Endoscopic Powered Stapler - Short
• 00851574008639: Endoscopic Powered Stapler - Long