Desara One

Basic Information

• Brand Name: Desara One
• Primary DI: 00890594000971
• Version / Model: CAL-DS2113
• Company Name: Caldera Medical, Inc.
• Labeler DUNS: 130341956
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-25
• Public Version: 4
• Public Version Date: 2022-07-19
• Public Version Status: Update
• Public Device Record Key: 5b2b677c-3212-4516-873c-d22f53253f42

Device Description

Single Incision Sling System (3/box)

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
PAH	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling	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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00890594000971	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K191416	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures.