FDA UDI
In Commercial Distribution
🇺🇸 United States
General Instruments
DI: 00840180528679
·
Model: CI-11601-01
·
ALPHATEC SPINE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- General Instruments
- Primary DI
- 00840180528679
- Version / Model
- CI-11601-01
- Company Name
- ALPHATEC SPINE, INC.
- Labeler DUNS
- 602465783
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-02
- Public Version
- 1
- Public Version Date
- 2024-06-10
- Public Version Status
- New
- Public Device Record Key
- 1bb1a4ab-0294-4594-8406-ae8127edbb69
Device Description
LIF Cup Curette, Size 1, Push
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
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HTF | CURETTE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47022 | Neurosurgical curette, single-use | A hand-held manual surgical instrument intended to be used to scrape and debride tissue from a bone surface (e.g., cancellous vertebral bone of the spine) or a cavity wall during a neurosurgical procedure. It consists of a long, thin, metal shaft that terminates distally into a spoon-, scoop- or mushroom-like cutting head, that can be set at alternative angles, which enables a smooth scoring action for the creation of grooves or channels. It is typically used during percutaneous kyphoplasty to treat vertebral compression fractures (VCFs), or during craniotomy or brain microsurgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840180528679 | GS1 |
Customer Contacts
- Phone
- +1(760)431-9286
- [email protected]