FDA UDI
In Commercial Distribution
🇺🇸 United States
Davida Neurosurgery Retractor and Hand Stabilization Systems
DI: 00842102114748
·
Model: 38055
·
FLEXBAR MACHINE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Davida Neurosurgery Retractor and Hand Stabilization Systems
- Primary DI
- 00842102114748
- Version / Model
- 38055
- Company Name
- FLEXBAR MACHINE CORPORATION
- Labeler DUNS
- 047644935
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-12
- Public Version
- 1
- Public Version Date
- 2021-10-20
- Public Version Status
- New
- Public Device Record Key
- 96511b5f-880b-436f-8f93-c8743c3203df
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GZT | Retractor, Self-Retaining, For Neurosurgery | Neurology | 882.4800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62772 | Neurosurgical retraction system, brain | A frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism dedicated to the temporary parting of brain tissue during neurosurgery. It includes a mounting frame, mountable retracting blades, and may be intended to attach to a skull clamp (not included). It is typically made of high-grade stainless steel and synthetic polymer materials. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842102114748 | GS1 |