Desara Blue TVez 3.0

Basic Information

• Brand Name: Desara Blue TVez 3.0
• Primary DI: 00890594000087
• Version / Model: CAL-DS01BTV30
• Company Name: Caldera Medical, Inc.
• Labeler DUNS: 130341956
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-15
• Public Version: 3
• Public Version Date: 2022-07-19
• Public Version Status: Update
• Public Device Record Key: 95332348-6fb2-4f8c-b830-22a99f9d22a4

Device Description

Desara Blue TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	878.3300	2
PWJ	Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence	Obstetrics/Gynecology	884.4910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	Yes	Active
47441	Transvaginal needle, surgical	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 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 sling. The proximal end can have a handle made of metal or durable plastic. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00890594000087	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K211975	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.