FDA UDI
In Commercial Distribution
🇺🇸 United States
TRAUMAGEL ®
DI: 00860007891144
·
Model: TG-0001
·
Cresilon, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- TRAUMAGEL ®
- Primary DI
- 00860007891144
- Version / Model
- TG-0001
- Company Name
- Cresilon, Inc.
- Labeler DUNS
- 035745047
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-08
- Public Version
- 4
- Public Version Date
- 2025-06-13
- Public Version Status
- Update
- Public Device Record Key
- 51a41f09-8700-4fe5-8b0e-fde94f55bc11
Device Description
Hemostatic Gel
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
- No
- 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 |
|---|---|---|---|---|
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47764 | Wound hydrogel dressing, non-antimicrobial | A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860007891144 | GS1 | ||||
| Package | 00860007891151 | GS1 | Carton | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- 3474352226
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240713 | 000 |