AccessGUDID - DEVICE: SOOTHE-GUARD® (D0036619050001)

GUDID

Device Identifier (DI) Information

Brand Name: SOOTHE-GUARD®
Version or Model: 661905000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 661905000
Company Name: Dentsply International Inc.

Primary DI Number: D0036619050001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 795572718 *Terms of Use

Device Description: Soothe-Guard® Adult Apron with Collar .35mm - Light Blue

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?
38355	Radiation shielding apron	A full or half-length apron-like garment intended to shield portions of the body of an individual (i.e., a device operator, patient, or other attending person) from exposure to radiation during medical or dental procedures. Some include attached or detachable collars for neck and thyroid protection. The device typically consists of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Those used for neutron attenuation are composed of hydrogenous materials; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EAJ	Apron, leaded

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
Special Storage Condition, Specify: Models with magnetic closure may have potential magnetic interference with pacemakers, defibrillators, and other active implanted devices.
Special Storage Condition, Specify: Hang or store flat

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fb5e3b22-18cd-4a04-8c4f-9d36317cb70a
Public Version Date: December 02, 2022
Public Version Number: 1
DI Record Publish Date: November 24, 2022