FDA UDI
In Commercial Distribution
🇺🇸 United States
ClearFit
DI: 00855113008098
·
Model: 171708
·
LONGEVITI NEURO SOLUTIONS LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ClearFit
- Primary DI
- 00855113008098
- Version / Model
- 171708
- Catalog Number
- 171708
- Company Name
- LONGEVITI NEURO SOLUTIONS LLC
- Labeler DUNS
- 070659539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-09
- Public Version
- 1
- Public Version Date
- 2020-03-17
- Public Version Status
- New
- Public Device Record Key
- 0a0f66a8-5123-4942-bf97-263d2e798c0f
Device Description
Extra Small Curved
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
- Yes
- 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 |
|---|---|---|---|---|
| PJN | Filler, Bone Void, Non-Alterable Compound For Cranioplasty | Neurology | 882.5330 | 2 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | Neurology | 882.5330 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16131 | Cranial resinous compound | A substance used to reconstitute cranial bone after neurosurgery (i.e., cranioplasty). It typically consists of a self-curing resin [e.g., polymethylmethacrylate (PMMA)] or a two part resinous material made of several compositions. It may be conformed as an inert implant in an appropriate shape (e.g., a plate) needed to repair the defect of the skull, either using an intraoperatively cured solid composition, or a preoperatively fabricated, porous, custom-made, implant. After application, this device cannot be reused. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00855113008098 | GS1 |
Customer Contacts
- Phone
- 410-527-1803
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170410 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Area/Surface Area | 37 | Square centimeter |