FDA UDI
In Commercial Distribution
🇺🇸 United States
NuStat
DI: 00850392006155
·
Model: N-0404NT
·
BEEKEN BIOMEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- NuStat
- Primary DI
- 00850392006155
- Version / Model
- N-0404NT
- Company Name
- BEEKEN BIOMEDICAL LLC
- Labeler DUNS
- 028807882
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-01
- Public Version
- 2
- Public Version Date
- 2024-05-16
- Public Version Status
- Update
- Public Device Record Key
- c0f67809-18a5-4f50-ad36-2a2a5b75c4c9
Device Description
NuStat 4x4
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62744 | Wound dressing kit, non-medicated | A collection of instruments and dressings intended to be used to dress a wound. Items typically include scissors, forceps, gauze, and cotton-tip applicators; it does not contain a pharmaceutical. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850392006155 | GS1 | ||||
| Package | 10850392006152 | GS1 | Shelf Pack | 50 | In Commercial Distribution | |
| Package | 20850392006159 | GS1 | Shelf Pack | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160578 | 000 |