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Endo-Scrub®

FDA UDI

Class II (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name
ENDO-SCRUB® FDA UDI
Generic Name
Optical medical device procedural cover FDA UDI
Device Name
SHEATH 1912024 5PK 2.7MM/0DEG SMITH-NEPH FDA UDI
Model / Reference
1912024 FDA UDI
Description
SHEATH 1912024 5PK 2.7MM/0DEG SMITH-NEPH FDA UDI

Identifiers

Primary DI / UDI-DI
20681490050948 FDA UDI
510(k) Number
K982594 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

Dimensions & Sizes

Size
Lumen/Inner Diameter — 2.7 Millimeter FDA UDI
Angle — 0.0 degree FDA UDI

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

Cleared under the same submission

K982594 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Xomed, Inc.

Sources (1)

  • FDA UDI 5cfd1fc8-8a47-4bc5-a512-0fd10b214799 37 fields · synced May 31, 2026