FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BlastX™
DI: 00370858000072
·
Model: MC-WG-0011-30
·
NEXT SCIENCE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
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Basic Information
- Brand Name
- BlastX™
- Primary DI
- 00370858000072
- Version / Model
- MC-WG-0011-30
- Company Name
- NEXT SCIENCE, LLC
- Labeler DUNS
- 043989331
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2018-09-25
- Public Version
- 3
- Public Version Date
- 2026-01-06
- Public Version Status
- Update
- Public Device Record Key
- ea41db00-d3db-412d-a190-ed7a8a768cea
- Distribution End Date
- 2025-12-31
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| 59522 | Wound hydrogel dressing, antimicrobial | A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, 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. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00370858000072 | GS1 | ||||
| Unit of Use | 00370858000065 | GS1 |
Customer Contacts
- Phone
- 855-564-2762
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163188 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 3.5 | Milliliter |