FDA UDI
In Commercial Distribution
🇺🇸 United States
STFR Radial Patch
DI: 00862499000264
·
Model: 2160
·
Chitogen Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- STFR Radial Patch
- Primary DI
- 00862499000264
- Version / Model
- 2160
- Company Name
- Chitogen Inc
- Labeler DUNS
- 010307324
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-18
- Public Version
- 1
- Public Version Date
- 2024-03-26
- Public Version Status
- New
- Public Device Record Key
- 9c1cd7bd-f315-44b5-81b1-d0142dfec31a
Device Description
Topical hemostatic pad
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
- Yes
- 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 |
|---|---|---|---|---|
| 46855 | Wound-nonadherent dressing, permeable, non-antimicrobial | A wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin upon removal; it does not contain an antimicrobial agent. Its pores permit the drainage of exudates from, and application of medication to, the wound. It may be used with other wound-care products for chronic and postoperative wounds, burns, skin graft fixation/cultured-cell carrier, cuts, or abrasions; it is neither a dedicated burn dressing nor 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 | 10862499000261 | GS1 | Box | 1000 | In Commercial Distribution | |
| Primary | 00862499000264 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090100 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 1.25 | Inch | |
| Width | 1.25 | Inch |