Tissue Goo™ Hemostatic Gel Big Shot Syringe Kit 641960
GUDID 00359883005672
Gingival Retraction Solution
DEN-MAT HOLDINGS, LLC
Gingival retraction solution| Primary Device ID | 00359883005672 |
| NIH Device Record Key | e7f3bdab-5aa1-4b1c-b189-85ca3f4472f4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tissue Goo™ Hemostatic Gel Big Shot Syringe Kit |
| Version Model Number | 641960 |
| Catalog Number | 641960 |
| Company DUNS | 809857704 |
| Company Name | DEN-MAT HOLDINGS, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com |
Device Dimensions
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store in cool, well-ventilated area. |
| Handling Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store in cool, well-ventilated area. |
| Handling Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store in cool, well-ventilated area. |
| Handling Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store in cool, well-ventilated area. |
| Handling Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store in cool, well-ventilated area. |
| Handling Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store in cool, well-ventilated area. |
| Handling Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store in cool, well-ventilated area. |
| Handling Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store in cool, well-ventilated area. |
| Handling Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store in cool, well-ventilated area. |
| Handling Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store in cool, well-ventilated area. |
| Handling Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store in cool, well-ventilated area. |
| Handling Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store in cool, well-ventilated area. |
| Handling Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store in cool, well-ventilated area. |
| Handling Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store in cool, well-ventilated area. |
| Handling Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store in cool, well-ventilated area. |
| Handling Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store in cool, well-ventilated area. |
| Handling Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store in cool, well-ventilated area. |
| Handling Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00359883005672 [Primary] |
FDA Product Code
| MVL | CORD, RETRACTION |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-26 |
| Device Publish Date | 2025-03-18 |
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Trademark Results [Tissue Goo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TISSUE GOO 76575183 2999897 Live/Registered |
Clinician's Choice Dental Products, Inc. 2004-02-10 |
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