SoftSeal
GUDID 00862499000202
Topical hemostatic pad
Chitogen Inc
Wound-nonadherent dressing, permeable, non-antimicrobial| Primary Device ID | 00862499000202 |
| NIH Device Record Key | ab1a14af-2b88-4c59-97a8-0cfce2b21d2b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SoftSeal |
| Version Model Number | 2150 |
| Company DUNS | 010307324 |
| Company Name | Chitogen Inc |
| 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 | true |
| 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 |
Device Dimensions
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
| Length | 2 Inch |
| Width | 2 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00862499000202 [Primary] |
| GS1 | 10862499000209 [Package] Package: [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K090100
FDA Product Code
| FRO | Dressing, Wound, Drug |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics |
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 | 2020-11-06 |
| Device Publish Date | 2020-10-29 |
Devices Manufactured by Chitogen Inc
| 10862499000261 - STFR Radial Patch | 2024-03-26 Topical hemostatic pad |
| 00862499000202 - SoftSeal | 2020-11-06Topical hemostatic pad |
| 00862499000202 - SoftSeal | 2020-11-06 Topical hemostatic pad |
| 10862499000254 - D-SEAL | 2020-11-06 hemostatic dressing |
Trademark Results [SoftSeal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOFTSEAL 97127496 not registered Live/Pending |
CHITOGEN INC 2021-11-16 |
 SOFTSEAL 90525213 not registered Live/Pending |
C1 EQUIPMENT LLC 2021-02-11 |
 SOFTSEAL 88117548 not registered Live/Pending |
12th Man Technologies, Inc. 2018-09-14 |
 SOFTSEAL 87577204 5442772 Live/Registered |
William Prym GmbH & Co. KG 2017-08-21 |
 SOFTSEAL 85543121 4739369 Live/Registered |
12th Man Technologies, Inc. 2012-02-15 |
 SOFTSEAL 79024483 3247806 Dead/Cancelled |
William Prym GmbH & Co. KG 2006-02-24 |
 SOFTSEAL 78508702 3058855 Live/Registered |
Oregon Aero, Inc. 2004-10-29 |
 SOFTSEAL 78122975 2823028 Dead/Cancelled |
CALIGEN FOAM LIMITED 2002-04-19 |
 SOFTSEAL 77849870 3884101 Dead/Cancelled |
Water Pik, Inc. 2009-10-15 |
 SOFTSEAL 77843778 not registered Dead/Abandoned |
PACKERS PLUS ENERGY SERVICES INC. 2009-10-07 |
 SOFTSEAL 77522633 3948176 Live/Registered |
Chitogen Inc 2008-07-15 |
 SOFTSEAL 76697070 not registered Dead/Abandoned |
Fezza, John P. 2009-04-24 |
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