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SuperDART® ONE PASS™ Validated Channel Cleaning Kit

FDA UDI

Class I (US FDA UDI)

by Primed Instruments Inc

Identity

Trade Name
SuperDART® ONE PASS™ Validated Channel Cleaning Kit FDA UDI
Generic Name
Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
Device Name
KIT BRUSH CLEANING 3 TO 4.5MM SuperDART SQUEEGEE SUCTION WELL (9293 + 9990). HIBC/UPN: M45393992 FDA UDI
Model / Reference
9399 FDA UDI
Description
KIT BRUSH CLEANING 3 TO 4.5MM SuperDART SQUEEGEE SUCTION WELL (9293 + 9990). HIBC/UPN: M45393992 FDA UDI

Identifiers

Catalog Number
9399-25 FDA UDI
Primary DI / UDI-DI
00666416121311 FDA UDI
FDA Product Code
MNL FDA UDI
GMDN Term
Surgical instrument/endoscope cleaning utensil, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.1500 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

Yes

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical instrument/endoscope cleaning utensil, single-use

SuperDART® ONE PASS™ Validated Channel Cleaning Kit by Primed Instruments Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument/endoscope cleaning utensil, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Primed Instruments Inc

Sources (1)

  • FDA UDI c198600d-10c5-4590-9ea1-34bb0fe559e6 36 fields · synced Jun 6, 2026