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Tenzing 8 Delivery Catheter

FDA UDI

Class II (US FDA UDI)

by Route 92 Medical, Inc.

Identity

Trade Name
Tenzing 8 Delivery Catheter FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
Tenzing 8 Delivery Catheter FDA UDI
Model / Reference
Gen 1 FDA UDI
Description
Tenzing 8 Delivery Catheter FDA UDI

Identifiers

Primary DI / UDI-DI
00853799007299 FDA UDI
FDA Product Code
QJP FDA UDI
GMDN Term
Vascular guide-catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Vascular guide-catheter, single-use

Tenzing 8 Delivery Catheter by Route 92 Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular guide-catheter, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Route 92 Medical, Inc.

Sources (1)

  • FDA UDI 2e2fa2b6-85a9-4743-9e6c-da67d56c357e 34 fields · synced Jun 1, 2026