← Back to catalogue

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 225101 20PK ENT 1000 FDA UDI
Model / Reference
225101 FDA UDI
Description
SHEATH 225101 20PK ENT 1000 FDA UDI

Identifiers

Primary DI / UDI-DI
20613994394693 FDA UDI
510(k) Number
K012543 FDA UDI
FDA Product Code
EOB FDA UDI
GMDN Term
Optical medical device procedural cover FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4760 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

Cleared under the same submission

K012543 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medtronic Xomed, Inc.

Sources (1)

  • FDA UDI 0573ef5f-5921-4c38-9169-4fe1899c2932 36 fields · synced Jun 8, 2026