ChitoGauze®XR PRO 3" x 4 yds Prometheus 1089
GUDID 50870053000013
HemCon ChitoGauze®XR PRO is a haemostatic dressing for the external, temporary control of severely bleeding wounds.
TRICOL BIOMEDICAL, INC.
Chitosan haemostatic agent| Primary Device ID | 50870053000013 |
| NIH Device Record Key | 7c2f45a7-be42-4891-b5d7-9a3a04f1c2f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ChitoGauze®XR PRO 3" x 4 yds Prometheus |
| Version Model Number | 1 |
| Catalog Number | 1089 |
| Company DUNS | 080240553 |
| Company Name | TRICOL BIOMEDICAL, 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00870053000018 [Primary] |
| GS1 | 50870053000013 [Package] Contains: 00870053000018 Package: Case [50 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K102546
FDA Product Code
| FRO | Dressing, Wound, Drug |
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 | 2021-02-04 |
| Device Publish Date | 2021-01-27 |
Devices Manufactured by TRICOL BIOMEDICAL, INC.
| 20870053000562 - ChitoGauzeXR PRO, 3in x 4yds | 2024-06-07 HemCon ChitoGauzeXR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds. |
| 20870053000401 - HemCon® OneStop® Vascular, 2in x 2in | 2022-04-13 The OneStop™ Dressing is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop™ dress |
| 20870053000418 - HemCon® OneStop® Vascular, 1.5in x 1.5in, Pre-Slit | 2022-04-13 The OneStop™ Vascular Pre-Slit is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop |
| 20870053001033 - HemCon® Dental Dressing PRO, 10mm x 12mm | 2021-07-19 The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection o |
| 20870053001118 - HemCon® Dental Dressing PRO, 1in x 3in | 2021-07-19 The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection o |
| 00870053001268 - HemCon® Strip PRO, 1in x 4in | 2021-07-19 The HemCon® Strip PRO is a wound dressing manufactured from chitosan. When applied directly to the wound, the HemCon® Strip PR |
| 00870053000117 - GuardaCare®XR Surgical, 4in x 4in, 8ply | 2021-07-16 HemCon GuardaCareXR Surgical is a hemostatic temporary surgical dressing comprised of a chitosan coated polyester/rayon blend, n |
| 20870053000333 - HemCon® OneStop™ Bandage, 2in x 2in | 2021-05-13 The OneStop™ Bandage is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop™ Bandag |
Trademark Results [ChitoGauze]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CHITOGAUZE 77611455 3825898 Live/Registered |
TRICOL BIOMEDICAL, INC. 2008-11-10 |
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