FDA UDI
In Commercial Distribution
🇺🇸 United States
Spark
DI: 00082161404170
·
Model: 40417
·
BROWNMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Spark
- Primary DI
- 00082161404170
- Version / Model
- 40417
- Company Name
- BROWNMED, INC.
- Labeler DUNS
- 091999771
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-18
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 89fd0354-487f-4b1e-837a-69d7130928bf
Device Description
Spark Kinetic Elbow
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IOY | Support, Arm | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42782 | Elbow joint orthosis component | A prefabricated (non-customized) externally applied and wearable orthopaedic device designed as a component of an upper limb orthosis to allow or control motion of the elbow joint. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00082161404170 | GS1 |