AccessGUDID - DEVICE: Health-Tec X-Ray Head Sleeves (D773660HT15261)

GUDID

Device Identifier (DI) Information

Brand Name: Health-Tec X-Ray Head Sleeves
Version or Model: 660-HT1526
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 660-HT1526
Company Name: Dental Health Products Inc

Primary DI Number: D773660HT15261
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 250
Labeler D-U-N-S® Number*: 623191194 *Terms of Use

Device Description: Health-Tec X-Ray Head Sleeves, 15" x 26"

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:	Yes
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?
61049	Instrument/equipment drape, single-use, non-sterile	A non-sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various instruments/equipment (e.g., dental chairs, treatment tables), to provide a barrier against cross-contamination in the home or healthcare facility. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
PEM	Dental Barriers And Sleeves

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160232	000

Device Exempt from Premarket Submission: No 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
Device Size Text, specify: 15" x 26"

Device Record Status

Public Device Record Key: 375a8241-8461-483b-ab64-7a992e542008
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 24, 2017