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Natus®

FDA UDI

Class I (US FDA UDI)

by Natus Medical Incorporated

Identity

Trade Name
Natus® FDA UDI
Generic Name
Subcutaneous tunneller, reusable FDA UDI
Device Name
PERITONEAL INTRODUCER SHEATH, 70 cm (27.5 Inches) FDA UDI
Model / Reference
NT9MD170 FDA UDI
Description
PERITONEAL INTRODUCER SHEATH, 70 cm (27.5 Inches) FDA UDI

Identifiers

Catalog Number
NT9MD170 FDA UDI
Primary DI / UDI-DI
00382830054140 FDA UDI
510(k) Number
K771529 FDA UDI
FDA Product Code
GYK FDA UDI
GMDN Term
Subcutaneous tunneller, reusable 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, reusable

Natus® by Natus Medical Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Subcutaneous tunneller, reusable.

Cleared under the same submission

K771529 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Natus Medical Incorporated

Sources (1)

  • FDA UDI 4bdb8d79-317f-4394-81c9-c8b85c20be05 37 fields · synced May 30, 2026