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Morpheus

FDA UDI

Class II (US FDA UDI)

by Angiodynamics, Inc.

Identity

Trade Name
Morpheus FDA UDI
Generic Name
Vascular catheter introduction set, nonimplantable FDA UDI
Device Name
Splittable Sheath Dilator Assembly FDA UDI
Model / Reference
06508403 FDA UDI
Description
Splittable Sheath Dilator Assembly FDA UDI

Identifiers

Primary DI / UDI-DI
H787065084030 FDA UDI
510(k) Number
K051655 FDA UDI
FDA Product Code
DQX FDA UDI
DRC FDA UDI
DYB FDA UDI
DQR FDA UDI
GMDN Term
Vascular catheter introduction set, nonimplantable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1330 FDA UDI
870.1390 FDA UDI
870.1340 FDA UDI
870.1300 FDA UDI
Commercial Distribution
Not 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

Dimensions & Sizes

Size
Catheter Gauge — 5 French FDA UDI

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

Cleared under the same submission

K051655 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Angiodynamics, Inc.

Sources (1)

  • FDA UDI 406c927f-8999-457b-b42b-7d9f80e7700a 38 fields · synced Jun 8, 2026