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Reprocessed 4mm EndoScrub Sheath, 70 deg

FDA UDI

Class I (US FDA UDI)

by Suretek Medical

Identity

Trade Name
Reprocessed 4mm EndoScrub Sheath, 70 deg FDA UDI
Generic Name
Paranasal sinus irrigation catheter FDA UDI
Model / Reference
191220 FDA UDI

Identifiers

Primary DI / UDI-DI
B3901912201 FDA UDI
FDA Product Code
KAM FDA UDI
GMDN Term
Paranasal sinus irrigation catheter FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Paranasal sinus irrigation catheter

Reprocessed 4mm EndoScrub Sheath, 70 deg by Suretek Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Paranasal sinus irrigation catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Suretek Medical

Sources (1)

  • FDA UDI 82d4ef6c-c690-438c-82cb-00d6f028ed9e 32 fields · synced Jun 1, 2026