FDA UDI
In Commercial Distribution
🇺🇸 United States
Natus®
DI: 00382830058162
·
Model: NT999007
·
NATUS MEDICAL INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Natus®
- Primary DI
- 00382830058162
- Version / Model
- NT999007
- Catalog Number
- NT999007
- Company Name
- NATUS MEDICAL INCORPORATED
- Labeler DUNS
- 081325959
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-03
- Public Version
- 1
- Public Version Date
- 2020-04-13
- Public Version Status
- New
- Public Device Record Key
- 9cbb2ae9-2d4a-4b77-b183-815d63b67a54
Device Description
Radiopaque Silicone Suturable Tubing Clamps For Natus F8 Catheter
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
- Yes
- MRI Safety
- MR Safe
- 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 |
|---|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | Neurology | 882.5550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61111 | Intracranial catheter holder | A small, sterile device designed to secure an intracranial catheter (e.g., intracerebral sensor catheter, intracerebral infusion/drainage catheter, epidural sensor catheter) to the skin; it may also be used as a marker for the planned depth of the catheter insertion. It typically has a gripping mechanism which creates a right angle bend in the tube, and is intended to be held in place with sutures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00382830055727 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00382830058162 | GS1 | ||||
| Previous | 10381780034469 | GS1 |
Customer Contacts
- Phone
- 1-800-356-0007
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101381 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 2.65mm O.D. (F8) |