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Desara Blue TV

FDA UDI

Class II (US FDA UDI)

by Caldera Medical, Inc.

Identity

Trade Name
Desara Blue TV FDA UDI
Generic Name
Female stress urinary incontinence surgical mesh-sling, synthetic polymer FDA UDI
Device Name
Desara Blue TV for the treatment of Stress Urinary Incontinence (SUI) or mixed incontinence. FDA UDI
Model / Reference
CAL-DS01BTV FDA UDI
Description
Desara Blue TV for the treatment of Stress Urinary Incontinence (SUI) or mixed incontinence. FDA UDI

Identifiers

Catalog Number
CAL-DS01BTV FDA UDI
Primary DI / UDI-DI
00890594000858 FDA UDI
510(k) Number
K162201 FDA UDI
FDA Product Code
OTN FDA UDI
GMDN Term
Female stress urinary incontinence surgical mesh-sling, synthetic polymer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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: Female stress urinary incontinence surgical mesh-sling, synthetic polymer

Desara Blue TV by Caldera Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Female stress urinary incontinence surgical mesh-sling, synthetic polymer.

Cleared under the same submission

K162201 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Caldera Medical, Inc.

Sources (1)

  • FDA UDI 84eece7a-399b-4271-8a6f-15a0a11e14ad 38 fields · synced Jun 6, 2026