AccessGUDID - DEVICE: AESCULAP (04046963398996)

GUDID

Device Identifier (DI) Information

Brand Name: AESCULAP
Version or Model: FE312K
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FE312K
Company Name: Aesculap AG

Primary DI Number: 04046963398996
Issuing Agency: GS1
Commercial Distribution End Date: April 19, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 315018218 *Terms of Use

Device Description: YASARGIL Clip Applier Forceps, bayonet, 9 3/4", (245 mm), working length: 4 3/8", (110 mm), bayonet-shaped, with ratchet, mini, stainless steel, non-sterile, reusable

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	No
For Single-Use:	No
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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Aneurysm clip applier	A surgical instrument designed for the application/insertion of aneurysm clips (devices for approximating the edges of the neck of an aneurysm or for the prevention of bleeding from small individual blood vessels). This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
HCI	APPLIER, ANEURYSM CLIP

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 53dc0d12-ec70-4d8b-80b6-aa1073d150d1
Public Version Date: June 27, 2018
Public Version Number: 3
DI Record Publish Date: May 19, 2016