DEVICE: Desara SL (00089059400766)

Device Identifier (DI) Information

Desara SL
CAL-DS01SL
In Commercial Distribution

CALDERA MEDICAL, INC.
00089059400766
GS1

1
130341956 *Terms of Use
Desara® SL sling system for female stress urinary incontinence.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Female stress urinary incontinence surgical mesh A sterile woven/knitted or porous material made of non-bioabsorbable synthetic polymer [e.g., polypropylene, polyethylene (PE)] intended to be permanently implanted to apply pressure to the urethra for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). May be referred to as a sling or subfascial hammock, it may include an adjusting suture and be positioned with a transobturator needle. It is typically available with various material attributes and may be pre-configured or cut to a desired size/shape. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.
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FDA Product Code

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Product Code Product Code Name
OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K121928 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: 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.
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 1.1cm x 12cm
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Device Record Status

3cd586e4-d99c-4dd2-aca1-5968f672dacc
July 06, 2018
3
May 27, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00890594000759 1 00089059400766 In Commercial Distribution box
00890594000742 5 00089059400766 In Commercial Distribution box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
1.866.422.5337
info@calderamedical.com
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