FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Katalyst™ Bipolar Radial Head System
DI: 10381780354604
·
Model: KATALYSTWANDIMP
·
Ascension Orthopedics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Katalyst™ Bipolar Radial Head System
- Primary DI
- 10381780354604
- Version / Model
- KATALYSTWANDIMP
- Catalog Number
- KATALYSTWANDIMP
- Company Name
- Ascension Orthopedics, Inc.
- Labeler DUNS
- 942377524
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-10
- Public Version
- 4
- Public Version Date
- 2023-05-02
- Public Version Status
- Update
- Public Device Record Key
- 2460095c-214f-40c5-a2cb-c63cd19e5242
- Distribution End Date
- 2023-03-31
Device Description
Katalyst Radial Head Sizing Wand Instruments
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| KWI | PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER | Orthopedic | 888.3170 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33701 | Elbow radius prosthesis | A sterile implantable device designed to replace the proximal radius typically as treatment for severe radial head fracture or degenerative disease (arthritis). The device includes a radial head or radial head with stem and is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] or metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) 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 |
|---|---|---|---|---|---|---|
| Secondary | M248KATALYSTWANDIMP1 | HIBCC | ||||
| Primary | 10381780354604 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K032806 | 000 |