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DirectVision

FDA UDI

Class II (US FDA UDI)

by Percuvision, LLC

Identity

Trade Name
DirectVision FDA UDI
Generic Name
Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
Device Name
14 Fr. Coude tip catheter for DirectVision system FDA UDI
Model / Reference
MA100282 FDA UDI
Description
14 Fr. Coude tip catheter for DirectVision system FDA UDI

Identifiers

Primary DI / UDI-DI
00855308006007 FDA UDI
510(k) Number
K110214 FDA UDI
FDA Product Code
EZL FDA UDI
GMDN Term
Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5130 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

No

FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 14 French FDA UDI

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

DirectVision by Percuvision, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.

Cleared under the same submission

K110214 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Percuvision, LLC

Sources (1)

  • FDA UDI d13bd72d-6e57-490e-a09c-529c953821bb 35 fields · synced May 31, 2026