FDA UDI
In Commercial Distribution
🇺🇸 United States
Discectomy Set
DI: M7403030113
·
Model: 15-02-08
·
SPINEOLOGY INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Discectomy Set
- Primary DI
- M7403030113
- Version / Model
- 15-02-08
- Catalog Number
- 303-0113
- Company Name
- SPINEOLOGY INC.
- Labeler DUNS
- 033014361
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-12
- Public Version
- 1
- Public Version Date
- 2024-01-22
- Public Version Status
- New
- Public Device Record Key
- c2deacda-2fb3-48a9-a7cb-e22c20acf710
Device Description
8x10mm L 30 degrees Curette w/ Teeth
Device Characteristics
- Single Use
- Yes
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47735 | Orthopaedic cement curette | A sterile, hand-held, manual surgical instrument designed to remove excess orthopaedic bone cement from an implantation site during the cementing of a prosthesis. It is typically made of plastic materials and consists of a handle proximally and a concave, spoon-like tip that is angled at the distal end, or it may be double-ended with the handle placed centrally. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M7403030113 | HIBCC |
Customer Contacts
- Phone
- 651-256-8500
- [email protected]