FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SV BOLSTER Medium
DI: 00856525007136
·
Model: SP2355
·
SUN SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SV BOLSTER Medium
- Primary DI
- 00856525007136
- Version / Model
- SP2355
- Catalog Number
- SP2355
- Company Name
- SUN SCIENTIFIC, INC.
- Labeler DUNS
- 609397224
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-26
- Public Version
- 3
- Public Version Date
- 2025-01-01
- Public Version Status
- Update
- Public Device Record Key
- feac492d-d05a-4915-89c3-87e320f64126
- Distribution End Date
- 2025-01-01
Device Description
SAPHENOUS VEIN COMPRESSION FOAM DRESSING WITH AIR BOLSTER MEDIUM
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
- 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 |
|---|---|---|---|---|
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | 878.4018 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44970 | Exudate-absorbent dressing, non-gel, non-antimicrobial | A wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856525007136 | GS1 |
Customer Contacts
- Phone
- 9144795108
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070457 | 000 |