FDA UDI
In Commercial Distribution
🇺🇸 United States
Cushing Elevator 19cm
DI: G25012089190
·
Model: 12-089-19
·
N S SURGICAL COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cushing Elevator 19cm
- Primary DI
- G25012089190
- Version / Model
- 12-089-19
- Catalog Number
- 12-089-19
- Company Name
- N S SURGICAL COMPANY
- Labeler DUNS
- 645681649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-27
- Public Version
- 1
- Public Version Date
- 2023-05-05
- Public Version Status
- New
- Public Device Record Key
- 66d7c12f-0877-4d31-bf89-7a7979c07f45
Device Description
A hand-held, manually-operated surgical instrument used to pry up, lift, and position a bone flap in a neurosurgical procedure upon the skull. Also known as a bone flap elevator it is typically a one-piece instrument that consists of a robust, long, round-nosed, dull blade at the distal working end and a handle at the proximal end. It is typically made of high-grade stainless steel. This is a reusable device.
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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Ethylene Oxide", "Moist Heat or Steam Sterilization", "Ultraviolet Light"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HTE | Elevator | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11507 | Neurosurgical bone flap elevator | A hand-held, manually-operated surgical instrument used to pry up, lift, and position a bone flap in a neurosurgical procedure upon the skull. Also known as a bone flap elevator it is typically a one-piece instrument that consists of a robust, long, round-nosed, dull blade at the distal working end and a handle at the proximal end. It is typically made of high-grade stainless steel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G25012089190 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 19 | Centimeter |