AccessGUDID - DEVICE: ERGO-VAC (110 DEGREE H.V.E. HANDPIECE)WITHOUT SWIVEL ADAPTOR (STATIONARY) (D248B11181S0)

GUDID

Device Identifier (DI) Information

Brand Name: ERGO-VAC (110 DEGREE H.V.E. HANDPIECE)WITHOUT SWIVEL ADAPTOR (STATIONARY)
Version or Model: B11181S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HAGER WORLDWIDE, INC.

Primary DI Number: D248B11181S0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009277971 *Terms of Use

Device Description: Ergo Vac (110 Degree HVE Handpiece) without swivel (Stationary Head)

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):	No
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?
34859	Dental suction system	An assembly of devices designed to aspirate water, blood, saliva, and tooth debris from the oral cavity by means of suction, to maintain a clear operative site during dental surgical, professional hygiene, and orthodontic procedures. It consists of an electrically-powered suction pump with a control knob and patient contact devices (typically suction handpiece/tip); collection containers, spittoon, tubing, and amalgam separator are also often included.	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: 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: 0a1cafa5-061b-4d24-b315-fee14aae87f1
Public Version Date: August 24, 2023
Public Version Number: 1
DI Record Publish Date: August 16, 2023