AccessGUDID - DEVICE: Dryz™ (00810000525386)

GUDID

Device Identifier (DI) Information

Brand Name: Dryz™
Version or Model: S192SP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S192SP
Company Name: PARKELL, INC.

Primary DI Number: 00810000525386
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009900424 *Terms of Use

Device Description: DryZ® Blu Syringe Gingival Retraction Paste Sample (Contains; 1- Syringe & 2-Tips)

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):	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?
35861	Gingival retraction cord, non-medicated	A non-medicated cotton string intended to be used to temporarily push gum tissue (gingiva) away from prepared tooth margins to help make an accurate dental impression. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVL	Cord, Retraction

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
Storage Environment Temperature: between 2 and 25 Degrees Celsius
Special Storage Condition, Specify: Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ec5b54e3-f9c7-4cbf-b0e6-b55694ade9f9
Public Version Date: April 03, 2024
Public Version Number: 4
DI Record Publish Date: February 07, 2020