FDA UDI
In Commercial Distribution
🇺🇸 United States
Access & Cavity Creation Kit
DI: 30850004171012
·
Model: 4.6mm (7G)
·
Lenoss Medical, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Access & Cavity Creation Kit
- Primary DI
- 30850004171012
- Version / Model
- 4.6mm (7G)
- Catalog Number
- 100.300
- Company Name
- Lenoss Medical, Inc.
- Labeler DUNS
- 066512552
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-12
- Public Version
- 1
- Public Version Date
- 2023-01-20
- Public Version Status
- New
- Public Device Record Key
- fb6a1e24-1011-424b-a5c3-29c1b4f4aae4
Device Description
Single use access and cavity creation instrument kit. Kit includes: cavity creator; diamond tip trocar-access cannula assembly; beveled tip trocar-access cannula assembly; bone tamp
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OCJ | Spinal Channeling Instrument, Vertebroplasty | Orthopedic | 888.4540 | 1 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58031 | Bone access channel kit | A collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create a bone space during kyphoplasty/osteoplasty. It typically consists of bone access needles/cannulae, orthopaedic bone wires (Kirschner wires), a drill, and a curette. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat a patient diagnosed with compression fractures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50850004171016 | GS1 | Shipper | 3 | In Commercial Distribution | |
| Primary | 30850004171012 | GS1 |
Customer Contacts
- Phone
- 1-844-553-6677
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 4.6 | Millimeter |