FDA UDI
In Commercial Distribution
🇺🇸 United States
Align
DI: 00841506134154
·
Model: ALIGN Radial Stem, Long Trial 7.0mm
·
SKELETAL DYNAMICS L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Align
- Primary DI
- 00841506134154
- Version / Model
- ALIGN Radial Stem, Long Trial 7.0mm
- Catalog Number
- ALN-STL-070
- Company Name
- SKELETAL DYNAMICS L.L.C.
- Labeler DUNS
- 869056148
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-11
- Public Version
- 1
- Public Version Date
- 2023-08-21
- Public Version Status
- New
- Public Device Record Key
- 4a516103-25d3-4b19-9ae5-58f15dffce0e
Device Description
ALIGN Radial Stem, Long Trial 7.0mm
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
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00841506134154 | GS1 |
Customer Contacts
- Phone
- +1(305)596-7585
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092721 | 000 |