FDA UDI
In Commercial Distribution
🇺🇸 United States
EPIX AntiRotation Device
DI: B2213315000001
·
Model: 3315-00000
·
Epix Orthopaedics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EPIX AntiRotation Device
- Primary DI
- B2213315000001
- Version / Model
- 3315-00000
- Catalog Number
- 3315-00000
- Company Name
- Epix Orthopaedics Inc.
- Labeler DUNS
- 084913303
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-05
- Public Version
- 2
- Public Version Date
- 2023-02-03
- Public Version Status
- Update
- Public Device Record Key
- 9bbb04f2-3d27-4e97-8706-9d024f3711cc
Device Description
Intramedullary And Accessories
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
- Yes
- 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 |
|---|---|---|---|---|
| HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | Orthopedic | 888.3020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55851 | Flexible bone nail | A bendable metallic rod intended to be implanted into the intramedullary canal of a long bone for fracture fixation where flexibility of the implant is desired. It is available in various lengths and diameters for use on lower and upper extremity diaphyseal fractures and some metaphyseal fractures of paediatrics and small-statured/normal adults to provide temporary stabilization of the bone segments/fragments until bone consolidation has been achieved. It is intended to splint the cortices and maintain elastic energy to continually brace against rotational/angular forces of the muscles. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B2213315000001 | HIBCC |
Customer Contacts
- Phone
- +1(844)710-9105
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133104 | 000 |