FreeClimb 70 reperfusion catheter, 132cm with Tenzing 7

FDA UDIEUDAMED

Class II (US FDA UDI)

by Route 92 Medical, Inc.

Identity

Trade Name: FreeClimb 70 reperfusion catheter, 132cm with Tenzing 7 FDA UDI
Generic Name: Thrombectomy suction catheter FDA UDI
Device Name: FreeClimb 70 reperfusion catheter, 132cm with Tenzing 7; Contains Tenzing 7 Delivery Catheter (00853799007541) and FreeClimb 70 reperfusion catheter, 132cm (00853799007183) FDA UDI
Model / Reference: Gen 1 FDA UDI
Description: FreeClimb 70 reperfusion catheter, 132cm with Tenzing 7; Contains Tenzing 7 Delivery Catheter (00853799007541) and FreeClimb 70 reperfusion catheter, 132cm (00853799007183) FDA UDI

Identifiers

Catalog Number: REF 7001-70-132R FDA UDI
Primary DI / UDI-DI: 00853799007497 FDA UDI
FDA Product Code: NRY FDA UDI
GMDN Term: Thrombectomy suction catheter 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Thrombectomy suction catheter

FreeClimb 70 reperfusion catheter, 132cm with Tenzing 7 by Route 92 Medical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Route 92 Medical, Inc.

Sources (2)

FDA UDI 020bd99e-320b-4c24-9ddf-c043a2f2ecaa 35 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced Jun 2, 2026