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Cereglide

FDA UDI

Class II (US FDA UDI)

by Cerenovus, Inc.

Identity

Trade Name
CEREGLIDE FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
CEREGLIDE 71 Intermediate Catheter 115 cm 0.071 in (1.80 mm) 0.0820 in (2.08 mm) 0.0825 in (2.10 mm) FDA UDI
Model / Reference
NIC71115U FDA UDI
Description
CEREGLIDE 71 Intermediate Catheter 115 cm 0.071 in (1.80 mm) 0.0820 in (2.08 mm) 0.0825 in (2.10 mm) FDA UDI

Identifiers

Catalog Number
NIC71115U FDA UDI
Primary DI / UDI-DI
10886704085355 FDA UDI
510(k) Number
K221930 FDA UDI
K221934 FDA UDI
FDA Product Code
QJP FDA UDI
NRY 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

Cereglide by Cerenovus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K221930 also covers:

K221934 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cerenovus, Inc.

Sources (1)

  • FDA UDI b3c3defc-8902-42d2-9ea5-fe90cf057885 36 fields · synced May 29, 2026