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GlideScope®

FDA UDI

Class I (US FDA UDI)

by Verathon Medical (Canada) ULC

Identity

Trade Name
GlideScope® FDA UDI
Generic Name
Endoscope sheath, single-use FDA UDI
Device Name
GlideScope® ClearFit™ MAC 4 Cover FDA UDI
Model / Reference
ClearFit™ MAC 4 Cover FDA UDI
Description
GlideScope® ClearFit™ MAC 4 Cover FDA UDI

Identifiers

Catalog Number
0574-0246 FDA UDI
Primary DI / UDI-DI
00879123008466 FDA UDI
FDA Product Code
CCW FDA UDI
GMDN Term
Endoscope sheath, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscope sheath, single-use

GlideScope® by Verathon Medical (Canada) ULC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscope sheath, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Verathon Medical (Canada) ULC

Sources (1)

  • FDA UDI a5868043-7845-437a-9618-ed844442f073 34 fields · synced May 30, 2026