AccessGUDID - DEVICE: Desara Blue TV (00890594000858)

GUDID

Device Identifier (DI) Information

Brand Name: Desara Blue TV
Version or Model: CAL-DS01BTV
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CAL-DS01BTV
Company Name: Caldera Medical, Inc.

Primary DI Number: 00890594000858
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 130341956 *Terms of Use

Device Description: Desara Blue TV for the treatment of Stress Urinary Incontinence (SUI) or mixed incontinence.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47986	Female stress urinary incontinence surgical mesh-sling, synthetic polymer	A woven/knitted or porous strip of material made of non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted (via transobturator, transvaginal, retropubic or suprapubic approach) to support the urethra for the treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). It typically includes an integral adjustment suture which may contain bioabsorbable polymer materials. It may also be referred to as a tape or subfascial hammock. Disposable devices associated with implantation may be supplied with the mesh-sling.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162201	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Desara Blue TV for SUI is recommended to be stored at room temperature in a clean dry place.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1.1 x 45 cm

Device Record Status

Public Device Record Key: 84eece7a-399b-4271-8a6f-15a0a11e14ad
Public Version Date: July 19, 2022
Public Version Number: 4
DI Record Publish Date: September 30, 2019