FDA UDI
In Commercial Distribution
🇺🇸 United States
DORO® Rod and Fixation Assembly
DI: 04250435502419
·
Model: 3037-04
·
pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DORO® Rod and Fixation Assembly
- Primary DI
- 04250435502419
- Version / Model
- 3037-04
- Company Name
- pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung
- Labeler DUNS
- 313517922
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-15
- Public Version
- 4
- Public Version Date
- 2021-03-11
- Public Version Status
- Update
- Public Device Record Key
- d333e227-bf84-4b23-81d6-81058b870889
Device Description
DORO® Rod and Fixation Assembly Radiolucent (Set), consists of: 3037-55 3037-08-001 3037-08-002
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | Neurology | 882.4460 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45181 | Surgical retraction system, reusable | A frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250435502419 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K063494 | 000 |