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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
00850012846222 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

Yes

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

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Manufacturer

Manufacturer
LSI Solutions, Inc.

Sources (1)

  • FDA UDI 2a2ac0f3-b44d-4ad0-95fd-875e7469e93b 36 fields · synced Jun 1, 2026