AccessGUDID - DEVICE: CLEARSPLINT (D810PCSD2095ZBESB111)

GUDID

Device Identifier (DI) Information

Brand Name: CLEARSPLINT
Version or Model: PCSD2095ZBESB1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PCSD2095ZBESB1
Company Name: ASTRON DENTAL CORPORATION

Primary DI Number: D810PCSD2095ZBESB111
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 056624901 *Terms of Use

Device Description: Clearsplint Disc 95mm x 20mm Clover Edge Blue BES 1 Unit

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):	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?
46492	Mouthguard, single-use	A prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during surgery or intubation. It is made of standard, preformed materials or items for adaptation to/direct insertion into the mouth. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQC	Mouthguard, Prescription

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111828	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
No Device Sizes

Device Record Status

Public Device Record Key: c6194eaa-da65-470d-a9b3-ea8c95c7de64
Public Version Date: February 06, 2023
Public Version Number: 1
DI Record Publish Date: January 27, 2023