TissueLink 32031775
GUDID 30009336010043
TissueLink - Flex
GRAPHIC CONTROLS ACQUISITION CORP
Skin-approximation adhesive| Primary Device ID | 30009336010043 |
| NIH Device Record Key | aec50097-2834-48b0-90fa-ccf07d62be85 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TissueLink |
| Version Model Number | 32031775 |
| Catalog Number | 32031775 |
| Company DUNS | 002111896 |
| Company Name | GRAPHIC CONTROLS ACQUISITION CORP |
| Device Count | 1 |
| 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 | true |
| 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
Device Dimensions
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Temperature: less than 72 degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00009336010042 [Primary] |
| GS1 | 30009336010043 [Package] Contains: 00009336010042 Package: Box [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K140343
FDA Product Code
| MPN | Tissue Adhesive For The Topical Approximation Of Skin |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-18 |
| Device Publish Date | 2021-01-08 |
On-Brand Devices [TissueLink]
| 30009336010043 | TissueLink - Flex |
| 30009336010036 | TissueLink - Blue |
| 00009336010028 | TissueLink - Clear |
Trademark Results [TissueLink]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TISSUELINK 88664265 not registered Live/Pending |
Graphic Controls Acquisition Corp. 2019-10-22 |
 TISSUELINK 78218964 2944941 Dead/Cancelled |
TissueLink Medical, Inc. 2003-02-26 |
 TISSUELINK 76012385 2772023 Dead/Cancelled |
SALIENT SURGICAL TECHNOLOGIES, INC. 2000-03-29 |
 TISSUELINK 76012378 2782263 Dead/Cancelled |
TISSUELINK MEDICAL, INC. 2000-03-29 |
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