AccessGUDID - DEVICE: Dryz™ (30810000525141)

GUDID

Device Identifier (DI) Information

Brand Name: Dryz™
Version or Model: S186
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: S186
Company Name: PARKELL, INC.

Primary DI Number: 30810000525141
Issuing Agency: GS1
Commercial Distribution End Date: April 15, 2024
Device Count: 30
Labeler D-U-N-S® Number*: 009900424 *Terms of Use

Device Description: Dryz BLU Gingival Retraction Paste Kit (Contains; 30-capsules & Dispensing Gun)

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?
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
Special Storage Condition, Specify: Refrigeration will prolong shelf life, but avoid freezing. Bring to room temperature before use.
Storage Environment Temperature: between 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cf999200-5d7a-4e12-9511-08ea6f8c59d0
Public Version Date: May 29, 2024
Public Version Number: 7
DI Record Publish Date: September 21, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00810000525140 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 6312491134
Email: customerservice@parkell.com

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