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Peelaway Introducer Sheath, 14Fr

FDA UDI

Class II (US FDA UDI)

by Clarus Medical, Llc

Identity

Trade Name
Peelaway Introducer Sheath, 14Fr FDA UDI
Generic Name
Endoscope sheath, single-use FDA UDI
Device Name
Peelaway Introducer Sheath, 14 French, Dome Tipped FDA UDI
Model / Reference
1305-014 FDA UDI
Description
Peelaway Introducer Sheath, 14 French, Dome Tipped FDA UDI

Identifiers

Catalog Number
1305-014 FDA UDI
Primary DI / UDI-DI
00810004820746 FDA UDI
510(k) Number
K200925 FDA UDI
FDA Product Code
GWG FDA UDI
GMDN Term
Endoscope sheath, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1480 FDA UDI
Commercial Distribution
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

Yes

FDA UDI

Category: Endoscope sheath, single-use

Peelaway Introducer Sheath, 14Fr by Clarus Medical, Llc — Class II — 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
Clarus Medical, Llc

Sources (1)

  • FDA UDI 6088df92-1052-4dfc-b7c4-9484b54c7d08 35 fields · synced May 30, 2026