AccessGUDID - DEVICE: AED (00848657015585)

GUDID

Device Identifier (DI) Information

Brand Name: AED
Version or Model: 27028BU
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Primary DI Number: 00848657015585
Issuing Agency: GS1
Commercial Distribution End Date: February 12, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 839138955 *Terms of Use

Device Description: Visual Obturator

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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58753	Arthroscopic obturator	A non-sterile, hand-held manual surgical instrument designed to fill the lumen of an arthroscopic sleeve (not included) to facilitate insertion of the sleeve into a joint (e.g., shoulder, knee) during arthroscopic examination or surgery. It is typically cannulated, made of metal, and available in a variety of sizes. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBH	ACCESSORIES,ARTHROSCOPIC

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 6d7e8bd3-ed45-4a42-93b6-9cc5a3f1ce00
Public Version Date: February 13, 2019
Public Version Number: 3
DI Record Publish Date: November 22, 2017