Dryz™ S187

GUDID 10810000525147

Dryz™ BLU Unit-Dose Gingival Retraction Paste (Pkg. of 30 Capsules)

PARKELL, INC.

Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated
Primary Device ID10810000525147
NIH Device Record Key635e5bad-a75a-4ef2-b218-fcf16e0b9470
Commercial Distribution StatusIn Commercial Distribution
Brand NameDryz™
Version Model NumberS187
Catalog NumberS187
Company DUNS009900424
Company NamePARKELL, INC.
Device Count30
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.

Device Identifiers

Device Issuing AgencyDevice ID
GS100810000525140 [Unit of Use]
GS110810000525147 [Primary]

FDA Product Code

MVLCord, Retraction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-09-20
Device Publish Date2018-09-21

On-Brand Devices [Dryz™]

00810000526819Dryz™ Unit-Dose Dispensing Gun
00810000525089Dryz™ Syringe Gingival Retraction Paste Sample (Contains; 1- Syringe & 2-Tips)
30810000525141Dryz BLU Gingival Retraction Paste Kit (Contains; 30-capsules & Dispensing Gun)
20810000525168Dryz Blu Syringe Gingival Retraction Paste Value Pack (Pkg. of 25 Syringes)
20810000525144Dryz™ BLU Unit-Dose Gingival Retraction Paste Sample (Contains; 3-Capsules)
20810000525106Dryz™ Unit-Dose Gingival Retaction Paste Sample (Contains; 3-Capsules)
20810000525083Dryz™ Syringe Gingival Retraction Paste Value Pack (Pkg. of 25 Syringes)
10810000525161Dryz™ Blu Syringe Gingival Retraction Paste (Pkg. of 7 Syringes)
10810000525147Dryz™ BLU Unit-Dose Gingival Retraction Paste (Pkg. of 30 Capsules)
10810000525109Dryz™ Unit-Dose Gingival Retraction Paste (Pkg. of 30 Capsules)
00810000525119Dryz™ Syringe Gingival Retraction Paste Sample (Contains; 1- Syringe & 2-Tips)
00810000525386DryZ® Blu Syringe Gingival Retraction Paste Sample (Contains; 1- Syringe & 2-Tips)
00810000525577Dryz™ Syringe Gingival Hemostatic Retraction Paste (Pkg. of 7 Syringes) for Korea
00810000526802Dryz™ Syringe Luer-Lock Applicator Tips (Pkg. of 40 pcs.)
10810000526809Dryz™ Syringe Luer-Lock Applicator Tips (Pkg. of 40 pcs.)
00810000525355DryZ® Syringe Gingival Retraction Paste Sample (Contains; 1- Syringe & 2-Tips) with Japanese I
10810000525086Dryz™ Syringe Gingival Hemostatic Retraction Paste (Pkg. of 7 Syringes)

Trademark Results [Dryz]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DRYZ
DRYZ
87078429 5133020 Live/Registered
Parkell Inc.
2016-06-21
DRYZ
DRYZ
78690420 3120553 Live/Registered
H.H. Brown Shoe Technologies, Inc.
2005-08-11
DRYZ
DRYZ
75676536 2395113 Live/Registered
H.H. Brown Shoe Technologies, Inc.
1999-04-06
DRYZ
DRYZ
75546219 2432628 Live/Registered
H.H. BROWN SHOE TECHNOLOGIES INC.
1998-08-24
DRYZ
DRYZ
75541430 2426063 Dead/Cancelled
H.H BROWN SHOE TECHNOLOGIES INC.
1998-08-24

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