Slide-On®

FDA UDI

Class II (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name: SLIDE-ON® FDA UDI
Generic Name: Optical medical device procedural cover FDA UDI
Device Name: SHEATH 445601 10PK SENSORY ENT-5000 FDA UDI
Model / Reference: 445601 FDA UDI
Description: SHEATH 445601 10PK SENSORY ENT-5000 FDA UDI

Identifiers

Primary DI / UDI-DI: 20613994657828 FDA UDI
510(k) Number: K031790 FDA UDI
FDA Product Code: EOB FDA UDI
EOX FDA UDI
GMDN Term: Optical medical device procedural cover FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.4760 FDA UDI
874.4710 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

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Optical medical device procedural cover

Slide-On® by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Optical medical device procedural cover.

EndoSheath Technology — COGENTIX MEDICAL, INC. · Class II
VELscope — Led Dental, Inc. · Class II
ML 830® — MICROLIGHT CORPORATION OF AMERICA · Class II
EndoSheath Technology — COGENTIX MEDICAL, INC. · Class II
EndoSheath Technology — COGENTIX MEDICAL, INC. · Class II
Sterile Sheath for CONVIVO — Carl Zeiss Meditec AG · Class II
Clear Guide SteriMASK — Clear Guide Medical · Class II
Clear Guide SteriMASK — Clear Guide Medical · Class II

Cleared under the same submission

K031790 also covers:

SLIDE-ON® — MEDTRONIC XOMED, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medtronic Xomed, Inc.

Sources (1)

FDA UDI 9fc95937-8da4-4123-8b37-148628b27087 35 fields · synced May 31, 2026