AccessGUDID - DEVICE: ProLube (D716MCPLBOX1001)

GUDID

Device Identifier (DI) Information

Brand Name: ProLube
Version or Model: MCPLBOX100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCPLBOX100
Company Name: TULSA DENTAL PRODUCTS LLC

Primary DI Number: D716MCPLBOX1001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 942778564 *Terms of Use

Device Description: PROLUBE 100 BOX

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?
45480	Dental root surface conditioner	A dental material, typically of neutral pH, used for topical application on exposed/scaled root surfaces for the removal of the smear layer (adherent debris produced when cutting the enamel or dentin in cavity or endodontic preparation, Circa 1 micron thick) during dental/periodontal surgery. The material is removed (washed off) after the recommended period to expose the collagenous matrix of dentine surfaces. It is typically presented in the form of a gel and consists of, e.g., edetate disodium (EDTA) and carboxymethylcellulose (CMC) with a neutral pH. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIC	SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 0f9c51ff-daa7-453f-9e86-6609f8ab87dd
Public Version Date: September 14, 2022
Public Version Number: 1
DI Record Publish Date: September 06, 2022