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Desara One

FDA UDI

Class II (US FDA UDI)

by Caldera Medical, Inc.

Identity

Trade Name
Desara One FDA UDI
Generic Name
Female stress urinary incontinence surgical mesh-sling, synthetic polymer FDA UDI
Device Name
Single Incision Sling System (3/box) FDA UDI
Model / Reference
CAL-DS2113 FDA UDI
Description
Single Incision Sling System (3/box) FDA UDI

Identifiers

Primary DI / UDI-DI
00890594000971 FDA UDI
510(k) Number
K191416 FDA UDI
FDA Product Code
PAH FDA UDI
PWJ 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
884.4910 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 One 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

K191416 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 5b2b677c-3212-4516-873c-d22f53253f42 36 fields · synced May 29, 2026