AccessGUDID - DEVICE: Adapter 11 to 16mm for HVE Air Protect XL, XL Plus (E247A7000600251)

GUDID

Device Identifier (DI) Information

Brand Name: Adapter 11 to 16mm for HVE Air Protect XL, XL Plus
Version or Model: A700060025
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DÜRR DENTAL SE

Primary DI Number: E247A7000600251
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315563684 *Terms of Use

Device Description: Dental Accessory

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?
38759	Dental suction system cannula, reusable	A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is made of metal or plastic materials that can be sterilized. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHZ	Evacuator, Oral Cavity

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: b2e3d9e1-1c0e-4e7a-afe9-81503e188000
Public Version Date: March 26, 2021
Public Version Number: 1
DI Record Publish Date: March 18, 2021