Vertessa Lite Y 22x5x4cm

Basic Information

• Brand Name: Vertessa Lite Y 22x5x4cm
• Primary DI: 00890594000452
• Version / Model: CAL-VLY2254
• Company Name: Caldera Medical, Inc.
• Labeler DUNS: 130341956
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-27
• Public Version: 6
• Public Version Date: 2022-07-19
• Public Version Status: Update
• Public Device Record Key: 6ac20638-b545-484b-8836-4c11f29c26a0

Device Description

Vertessa® Lite Y 22x5x4cm polypropylene mesh for sacrocolpopexy .

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
OTO	Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	General, Plastic Surgery	878.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59676	Pelvic organ prolapse surgical mesh, composite-polymer	A woven/knitted or porous material comprised of both a bioabsorbable polymer (e.g., poliglecaprone 25) and a non-bioabsorbable polymer (e.g., polypropylene) intended to be permanently implanted into a female patient for reinforcement and/or bridging of the supporting tissues of the pelvic floor for the surgical treatment of vaginal pelvic organ prolapse (POP), including anterior, posterior, or apical prolapse repair. It is typically available with various material attributes (e.g., density, pore size, weave) and may be pre-configured for specific repair or cut to desired size/shape. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00890594000445	GS1	box	1	In Commercial Distribution
Primary	00890594000452	GS1
Package	00890594000438	GS1	box	3	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K150023	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			22x5x4cm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: 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.