FDA UDI
In Commercial Distribution
🇺🇸 United States
DORO® Extensionbar Horseshoe
DI: 04250435501320
·
Model: 3009-25
·
Black Forest Medical GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DORO® Extensionbar Horseshoe
- Primary DI
- 04250435501320
- Version / Model
- 3009-25
- Company Name
- Black Forest Medical GmbH
- Labeler DUNS
- 313517922
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-11
- Public Version
- 3
- Public Version Date
- 2026-01-29
- Public Version Status
- Update
- Public Device Record Key
- 5fa1010a-b429-4d7e-8cd3-250ec56ee407
Device Description
DORO® Extensionbar Horseshoe incl. Screw
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
- MR Unsafe
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | Neurology | 882.4460 | 2 |
| HBM | Headrest, Neurosurgical | Neurology | 882.4440 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58055 | Operating/examination/treatment table headrest, reusable | A device designed to be attached to an operating/examination/treatment table to support the head, and sometimes shoulders, of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations conducted on such tables. It is available in various shapes and sizes and might include mechanisms to enable adjustments in relation to the table top. It does not include components intended for immobilization of the head (i.e., not a positioner). This is a reusable device after appropriate cleaning. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250435501320 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K001808 | 000 |