Dryz™ S191
GUDID 20810000525168
Dryz Blu Syringe Gingival Retraction Paste Value Pack (Pkg. of 25 Syringes)
PARKELL, INC.
Gingival retraction cord, non-medicated| Primary Device ID | 20810000525168 |
| NIH Device Record Key | 3cd48e5e-4391-4e2e-8ecc-e68185437f18 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dryz™ |
| Version Model Number | S191 |
| Catalog Number | S191 |
| Company DUNS | 009900424 |
| Company Name | PARKELL, INC. |
| Device Count | 25 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 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. |
| Special Storage Condition, Specify | Between 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. |
| Special Storage Condition, Specify | Between 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. |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 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 Agency | Device ID |
|---|---|
| GS1 | 00810000525164 [Unit of Use] |
| GS1 | 20810000525168 [Primary] |
FDA Product Code
| MVL | Cord, Retraction |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-09-20 |
| Device Publish Date | 2018-09-21 |
On-Brand Devices [Dryz™]
| 00810000526819 | Dryz™ Unit-Dose Dispensing Gun |
| 00810000525089 | Dryz™ Syringe Gingival Retraction Paste Sample (Contains; 1- Syringe & 2-Tips) |
| 30810000525141 | Dryz BLU Gingival Retraction Paste Kit (Contains; 30-capsules & Dispensing Gun) |
| 20810000525168 | Dryz Blu Syringe Gingival Retraction Paste Value Pack (Pkg. of 25 Syringes) |
| 20810000525144 | Dryz™ BLU Unit-Dose Gingival Retraction Paste Sample (Contains; 3-Capsules) |
| 20810000525106 | Dryz™ Unit-Dose Gingival Retaction Paste Sample (Contains; 3-Capsules) |
| 20810000525083 | Dryz™ Syringe Gingival Retraction Paste Value Pack (Pkg. of 25 Syringes) |
| 10810000525161 | Dryz™ Blu Syringe Gingival Retraction Paste (Pkg. of 7 Syringes) |
| 10810000525147 | Dryz™ BLU Unit-Dose Gingival Retraction Paste (Pkg. of 30 Capsules) |
| 10810000525109 | Dryz™ Unit-Dose Gingival Retraction Paste (Pkg. of 30 Capsules) |
| 00810000525119 | Dryz™ Syringe Gingival Retraction Paste Sample (Contains; 1- Syringe & 2-Tips) |
| 00810000525386 | DryZ® Blu Syringe Gingival Retraction Paste Sample (Contains; 1- Syringe & 2-Tips) |
| 00810000525577 | Dryz™ Syringe Gingival Hemostatic Retraction Paste (Pkg. of 7 Syringes) for Korea |
| 00810000526802 | Dryz™ Syringe Luer-Lock Applicator Tips (Pkg. of 40 pcs.) |
| 10810000526809 | Dryz™ Syringe Luer-Lock Applicator Tips (Pkg. of 40 pcs.) |
| 00810000525355 | DryZ® Syringe Gingival Retraction Paste Sample (Contains; 1- Syringe & 2-Tips) with Japanese I |
| 10810000525086 | Dryz™ Syringe Gingival Hemostatic Retraction Paste (Pkg. of 7 Syringes) |
Trademark Results [Dryz]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DRYZ 87078429 5133020 Live/Registered |
Parkell Inc. 2016-06-21 |
 DRYZ 78690420 3120553 Live/Registered |
H.H. Brown Shoe Technologies, Inc. 2005-08-11 |
 DRYZ 75676536 2395113 Live/Registered |
H.H. Brown Shoe Technologies, Inc. 1999-04-06 |
 DRYZ 75546219 2432628 Live/Registered |
H.H. BROWN SHOE TECHNOLOGIES INC. 1998-08-24 |
 DRYZ 75541430 2426063 Dead/Cancelled |
H.H BROWN SHOE TECHNOLOGIES INC. 1998-08-24 |
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