AccessGUDID - DEVICE: N/A (04710810084478)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 70106
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Durable Water Trap 22M
Company Name: GALEMED CORPORATION

Primary DI Number: 04710810084478
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 656854379 *Terms of Use

Device Description: No description.

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":	Yes
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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Dental suction system, surgical	An assembly of devices used to evacuate water, blood, saliva, and tooth debris from the oral cavity by means of suction, to maintain a clear operative site during dental surgical and some orthodontic procedures. It generally consists of an electric-motor suction pump, sterile rubber/plastic tubing, plastic/glass collection container(s), a vacuum gauge, a vacuum control knob, an overflow trap, a moisture filter, and possibly a microbial filter; it may also include an amalgam separator. The pump creates a vacuum in the suction tubing, which is inserted into oral cavity for the removal of materials into the collection container. This GMDN code applies to a stand-alone unit.

GMDN Preferred Term Name

GMDN Definition

Dental suction system, surgical

An assembly of devices used to evacuate water, blood, saliva, and tooth debris from the oral cavity by means of suction, to maintain a clear operative site during dental surgical and some orthodontic procedures. It generally consists of an electric-motor suction pump, sterile rubber/plastic tubing, plastic/glass collection container(s), a vacuum gauge, a vacuum control knob, an overflow trap, a moisture filter, and possibly a microbial filter; it may also include an amalgam separator. The pump creates a vacuum in the suction tubing, which is inserted into oral cavity for the removal of materials into the collection container. This GMDN code applies to a stand-alone unit.

FDA Product Code

[?]

Product Code	Product Code Name
BYH	Drain, Tee (Water Trap)

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
Storage Environment Temperature: between -40 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cf2436a2-075c-4fc9-a008-2a7a9b3f2835
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 15, 2015