← Back to catalogue

Jnw Urtrac

FDA UDI

Class I (US FDA UDI)

by LSI Solutions, Inc.

Identity

Trade Name
JNW URTRAC FDA UDI
Generic Name
Endoscope sheath, single-use FDA UDI
Device Name
JNW URTRAC INSTRUMENT GUIDE FDA UDI
Model / Reference
081300 FDA UDI
Description
JNW URTRAC INSTRUMENT GUIDE FDA UDI

Identifiers

Catalog Number
081300 FDA UDI
Primary DI / UDI-DI
00850012846451 FDA UDI
FDA Product Code
GEA FDA UDI
GMDN Term
Endoscope sheath, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Endoscope sheath, single-use

Jnw Urtrac by LSI Solutions, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscope sheath, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
LSI Solutions, Inc.

Sources (1)

  • FDA UDI e88ac6e0-9ae6-4cf1-9950-4f2e7ddd54ce 35 fields · synced Jun 8, 2026