Desara SL

GUDID 00089059400766

Desara® SL sling system for female stress urinary incontinence.

CALDERA MEDICAL, INC.

Stress urinary incontinence surgical mesh, female
Primary Device ID00089059400766
NIH Device Record Key3cd586e4-d99c-4dd2-aca1-5968f672dacc
Commercial Distribution StatusIn Commercial Distribution
Brand NameDesara SL
Version Model NumberCAL-DS01SL
Company DUNS130341956
Company NameCALDERA MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1.866.422.5337
Emailinfo@calderamedical.com

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.

Device Identifiers

Device Issuing AgencyDevice ID
GS100089059400766 [Primary]
GS100890594000742 [Package]
Package: box [5 Units]
In Commercial Distribution
GS100890594000759 [Package]
Package: box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OTOMesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-23
Device Publish Date2016-05-27

On-Brand Devices [Desara SL]

00089059400766Desara® SL sling system for female stress urinary incontinence.
00890594000766Desara® SL sling system for female stress urinary incontinence.

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