FDA UDI
In Commercial Distribution
🇺🇸 United States
HemCon ChitoGauze XR2 Pro, 3in x 4yd
DI: 00870053000315
·
Model: 1
·
TRICOL BIOMEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HemCon ChitoGauze XR2 Pro, 3in x 4yd
- Primary DI
- 00870053000315
- Version / Model
- 1
- Catalog Number
- 1101
- Company Name
- TRICOL BIOMEDICAL, INC.
- Labeler DUNS
- 080240553
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-14
- Public Version
- 1
- Public Version Date
- 2021-04-22
- Public Version Status
- New
- Public Device Record Key
- 29d5037c-b8b5-4424-b9b2-678e0508769a
Device Description
HemCon® ChitoGauze® XR2 Pro is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46922 | Chitosan haemostatic agent, professional | A non-bioabsorbable device that includes chitosan (a polysaccharide derived from chitin, the structural element in the exoskeleton of crustaceans) as a principal component, intended to be applied exclusively by healthcare professionals in a clinical setting to traumatic wounds in emergency situations (e.g., road accidents, combat, emergency rescue) or during surgical intervention to produce a rapid haemostasis by forming a robust plug of gel which is removed after use. The chitosan may be intended to provide antibacterial activity, and is available in a variety of forms (e.g., fine particles in a pouch, coated on gauze). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50870053000310 | GS1 | Case | 50 | In Commercial Distribution | |
| Primary | 00870053000315 | GS1 |
Customer Contacts
- Phone
- 9712231000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102546 | 000 |