FDA UDI
In Commercial Distribution
🇺🇸 United States
Oxiplex
DI: 00854395004507
·
Model: FPC-09010
·
Fziomed, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Oxiplex
- Primary DI
- 00854395004507
- Version / Model
- FPC-09010
- Company Name
- Fziomed, Inc.
- Labeler DUNS
- 966718371
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-11
- Public Version
- 1
- Public Version Date
- 2025-09-19
- Public Version Status
- New
- Public Device Record Key
- cdf15c75-2683-48c1-b75d-8e4400256b8b
Device Description
Absorbable gel for spine surgery
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
- MR Safe
- 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 |
|---|---|---|---|---|
| QVL | Absorbable Gel For Intraoperative Use In Spine Surgery | Orthopedic | 888.3047 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34212 | Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated | A bioabsorbable, surgically-implanted device intended to prevent the abnormal fibrous union (adhesion) between one internal body part/tissue and another following a surgical procedure; neither antimicrobials nor pharmaceuticals are included. It may be supplied as a barrier membrane, hydratable gel, or fluid dressing and is made of appropriate material (e.g., collagen- or hyaluronic acid-based) to reduce adhesion between adjacent anatomical structures. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10854395004504 | GS1 | Secondary (carton) | 1 | In Commercial Distribution | |
| Primary | 00854395004507 | GS1 |
Customer Contacts
- Phone
- 8055460610
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN240038 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 3 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius