FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOCERAM AZUL HEAD
DI: 04547898308260
·
Model: GMH04-400078
·
KYOCERA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BIOCERAM AZUL HEAD
- Primary DI
- 04547898308260
- Version / Model
- GMH04-400078
- Catalog Number
- GMH04-400078
- Company Name
- KYOCERA CORPORATION
- Labeler DUNS
- 690557624
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-21
- Public Version
- 4
- Public Version Date
- 2020-05-21
- Public Version Status
- Update
- Public Device Record Key
- d47515ef-9cf8-4437-b199-beeaed68efa6
Device Description
AZUL HEAD 44 +3.5
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
- No
- 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 |
|---|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | 888.3353 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33715 | Ceramic-on-polyethylene total hip prosthesis | A sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a ceramic-on-polyethylene or cross-linked polyethylene (PE) interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04547898308260 | GS1 |
Customer Contacts
- Phone
- 909-557-2360
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Taper: 12/14 | ||
| Device Size Text, specify | Offset: +3.5mm | ||
| Device Size Text, specify | Size: φ44MM O.D. |