AccessGUDID - DEVICE: AED-SLT KIT (00848657069441)

GUDID

Device Identifier (DI) Information

Brand Name: AED-SLT KIT
Version or Model: AED-SLT KIT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AED-SLT KIT
Company Name: NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Primary DI Number: 00848657069441
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 839138955 *Terms of Use

Device Description: A complete set of AED-SLT hermetic seal testers for Midas Rex, Stryker, Dyonics, Conmed Linvatec and Arthrex medical power tools including a hand-held aneroid sphygmomanometer with pressure inflation bulb

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:	Yes
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?
47856	Surgical power tool maintenance unit	A device used for the automatic internal lubrication and maintenance of surgical power tools (e.g., pneumatically or electrically driven motors, turbines, or attachments). This device will automatically run programs for the lubrication of the internal components with service oil and flushing with compressed air after external cleansing, but prior to sterilization. This process is intended to improve performance and safety of the surgical instruments. The unit is designed to accept different handpieces which are connected directly or via adaptors to the unit's processing chamber.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEY	Motor, Surgical Instrument, Ac-Powered

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: 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: 8d2d8c84-59fb-4bfc-8c59-57c435a1b337
Public Version Date: August 06, 2020
Public Version Number: 1
DI Record Publish Date: July 29, 2020