D-SEAL
GUDID 10862499000254
hemostatic dressing
Chitogen Inc
Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial| Primary Device ID | 10862499000254 |
| NIH Device Record Key | 5aec0ba4-e022-4de2-9f73-406e170a4661 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | D-SEAL |
| Version Model Number | 2010 |
| 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 |
Customer Support Contacts
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com | |
| Phone | 7635595670 |
| info@chitogen.com |
Device Dimensions
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00862499000257 [Primary] |
| GS1 | 10862499000254 [Package] Contains: 00862499000257 Package: [100 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 | 2020-11-06 Topical hemostatic pad |
| 10862499000254 - D-SEAL | 2020-11-06hemostatic dressing |
| 10862499000254 - D-SEAL | 2020-11-06 hemostatic dressing |
Trademark Results [D-SEAL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 D-SEAL 90142354 not registered Live/Pending |
CHITOGEN INC 2020-08-27 |
 D-SEAL 86785197 5115653 Live/Registered |
RED DEVIL, INC. 2015-10-12 |
 D-SEAL 74574750 not registered Dead/Abandoned |
ALKON CORPORATION 1994-09-16 |
 D-SEAL 74122244 not registered Dead/Abandoned |
Alkon Corporation 1990-12-10 |
 D-SEAL 74043538 1696764 Dead/Cancelled |
FOSTER OILFIELD EQUIPMENT CO. 1990-03-28 |
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