AccessGUDID - DEVICE: Desara Blue TVez 3.0 (00890594000087)

GUDID

Device Identifier (DI) Information

Brand Name: Desara Blue TVez 3.0
Version or Model: CAL-DS01BTV30
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Caldera Medical, Inc.

Primary DI Number: 00890594000087
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 130341956 *Terms of Use

Device Description: Desara Blue TVez 3.0mm for the treatment of female 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
47441	Transvaginal mesh-sling introduction needle	A hand-held manual surgical instrument with a sharp pyramidal or conical point designed to create a puncture in the vaginal wall for the surgical positioning of a mesh-sling typically used in the treatment of stress urinary incontinence (SUI) associated with bladder prolapse. The distal working end is typically made of a high-grade stainless steel curved rod with a pointed tip and an eye or notch to help position the mesh-sling. The proximal end can have a handle made of metal or durable plastic. This is a reusable device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211975	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 TVez is recommended to be stored at room temperature in a clean, dry location.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 95332348-6fb2-4f8c-b830-22a99f9d22a4
Public Version Date: August 07, 2024
Public Version Number: 4
DI Record Publish Date: November 15, 2021