FDA UDI
In Commercial Distribution
🇺🇸 United States
V. Mueller
DI: 10885403139901
·
Model: U-2224
·
STERIS CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- V. Mueller
- Primary DI
- 10885403139901
- Version / Model
- U-2224
- Catalog Number
- U2224
- Company Name
- STERIS CORPORATION
- Labeler DUNS
- 021599373
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-18
- Public Version
- 6
- Public Version Date
- 2024-09-13
- Public Version Status
- Update
- Public Device Record Key
- 7ef0a7c3-94bf-4f82-9c7a-4880155f25a8
Device Description
V. Mueller Neuro/Spine CHROMA-LINE MICRO SPINAL CURETTE, AXIAL STRAIGHT UP, 2-0, GOLD OVERALL LENGTH 9-1/4 inches 235MM
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 |
|---|---|---|---|---|
| HAO | INSTRUMENT, SURGICAL, NON-POWERED | Neurology | 882.4535 | 1 |
| GZX | INSTRUMENT, MICROSURGICAL | Neurology | 882.4525 | 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 | 10885403139901 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]