FDA UDI
In Commercial Distribution
🇺🇸 United States
EPIPHANY
DI: B528100418021023020
·
Model: 1
·
PANTHEON SPINAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EPIPHANY
- Primary DI
- B528100418021023020
- Version / Model
- 1
- Catalog Number
- 1004-1802 1023-02
- Company Name
- PANTHEON SPINAL, LLC
- Labeler DUNS
- 071012634
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-21
- Public Version
- 6
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 25d5652e-3ff6-44a9-b45f-92ecbba8a8f0
Device Description
CURVED 15 DEGREE UP/DOWN RASP 18MM
Device Characteristics
- Single Use
- No
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | 888.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35559 | Bone file/rasp, manual, reusable | A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B528100418021023020 | HIBCC |
Customer Contacts
- Phone
- 5122154888
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113781 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Angle | 15 | degree | |
| Height | 18 | Millimeter |