Identity
- Trade Name
- Natus® FDA UDI
- Generic Name
- Subcutaneous tunneller, single-use FDA UDI
- Device Name
- PERITONEAL INTRODUCER SHEATHS, 61 cm FDA UDI
- Model / Reference
- NT901124 FDA UDI
- Description
- PERITONEAL INTRODUCER SHEATHS, 61 cm FDA UDI
Identifiers
- Catalog Number
- NT901124 FDA UDI
- Primary DI / UDI-DI
- 00382830053624 FDA UDI
- 510(k) Number
- K771529 FDA UDI
- FDA Product Code
- GYK FDA UDI
- GMDN Term
- Subcutaneous tunneller, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 882.4545 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Subcutaneous tunneller, single-use
Natus® by Natus Medical Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Subcutaneous tunneller, single-use.
- AVANOS — Avanos Medical, Inc. · Class II
- CORTRAK* 2 Enteral Access System — Avanos Medical, Inc. · Class II
- AESCULAP — AESCULAP, INC. · Class I
- PMT® CORPORATION — Pmt Corp. · Class I
- Halyard — Avanos Medical, Inc. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
- Halyard — Avanos Medical, Inc. · Class II
- Mainstay Tunneler — MAINSTAY MEDICAL LIMITED · Class III
Cleared under the same submission
K771529 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Natus Medical Incorporated
Sources (1)
- FDA UDI 14863c8f-f079-4162-b0e3-e136f29b16bc 37 fields · synced May 30, 2026