← Back to catalogue

Desara Blue Short Suture Sling

FDA UDI

Class II (US FDA UDI)

by Caldera Medical, Inc.

Identity

Trade Name
Desara Blue Short Suture Sling FDA UDI
Generic Name
Female stress urinary incontinence surgical mesh-sling, synthetic polymer FDA UDI
Device Name
Desara® Blue Short Suture Sling for female stress urinary incontinence FDA UDI
Model / Reference
CAL-DS01BS FDA UDI
Description
Desara® Blue Short Suture Sling for female stress urinary incontinence FDA UDI

Identifiers

Primary DI / UDI-DI
00890594000735 FDA UDI
510(k) Number
K140843 FDA UDI
FDA Product Code
OTO 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 Short Suture Sling 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

K140843 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Caldera Medical, Inc.

Sources (1)

  • FDA UDI b8c2d348-4ac2-450f-b613-bc657a1c25fd 37 fields · synced May 30, 2026