FDA UDI
In Commercial Distribution
🇺🇸 United States
Natus®
DI: 00382830055239
·
Model: NT901218
·
NATUS MEDICAL INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Natus®
- Primary DI
- 00382830055239
- Version / Model
- NT901218
- Catalog Number
- NT901218
- 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
- 9b54ee7f-d7aa-452d-80b6-6bdf62c8b3bc
Device Description
STAINLESS STEEL PERITONEAL INTRODUCER, 46 cm
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
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PIY | Stainless Steel Instrument, Shunt System Implantation | Neurology | 882.4545 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46800 | Subcutaneous tunneller, reusable | A hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt, retinal chip). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382830055239 | GS1 | ||||
| Previous | 10381780033318 | GS1 |
Customer Contacts
- Phone
- 1-800-356-0007
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 46cm Length |