FDA UDI
In Commercial Distribution
🇺🇸 United States
Nalu Medical, Inc.
DI: 00812537034737
·
Model: 23003-045
·
NALU MEDICAL, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Nalu Medical, Inc.
- Primary DI
- 00812537034737
- Version / Model
- 23003-045
- Catalog Number
- 23003-045
- Company Name
- NALU MEDICAL, INC.
- Labeler DUNS
- 067140761
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-21
- Public Version
- 2
- Public Version Date
- 2022-10-03
- Public Version Status
- Update
- Public Device Record Key
- 983afda8-c123-45d3-a107-ba1ee202ddfb
Device Description
Tearaway introducer assembly (10 cm sheath)
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | Neurology | 882.5870 | 2 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | Neurology | 882.5880 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44063 | Neurosurgical procedure kit, non-medicated, single-use | A collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812537034737 | GS1 |
Customer Contacts
- Phone
- 1-800-618-3402
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 10 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 140 Degrees Fahrenheit