AccessGUDID - DEVICE: AEON (00850060791055)

GUDID

Device Identifier (DI) Information

Brand Name: AEON
Version or Model: AEPH160
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LEXINGTON MEDICAL, INC.

Primary DI Number: 00850060791055
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 079881514 *Terms of Use

Device Description: Endoscopic Powered Stapler - Medium

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62383	Motorized cutting stapler handpiece	A hand-held, electrically-powered proximal component of a motorized cutting stapler designed to be used during endoscopic transection and resection of tissues and the creation of anastomoses, and/or during open surgery. It is typically a pistol-like device with battery pack, motor, and controls, and is intended to accept a separate connector endpiece/loading unit (neither are included) to cut the tissue and simultaneously apply surgical staples along the cut line. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAG	Stapler, Surgical
GDW	Staple, Implantable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K234039	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bb11cf8d-1995-49cf-8b12-05947a1247bc
Public Version Date: June 03, 2024
Public Version Number: 1
DI Record Publish Date: May 24, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00851574008479 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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