Cervos Lipo Pro Double Pack

Basic Information

• Brand Name: Cervos Lipo Pro Double Pack
• Primary DI: 00850023741578
• Version / Model: CER-LP-40
• Catalog Number: CER-LP-40
• Company Name: RANFAC CORP.
• Labeler DUNS: 121622872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-17
• Public Version: 2
• Public Version Date: 2022-09-15
• Public Version Status: Update
• Public Device Record Key: 8bdb58db-2f52-4293-bcfc-230104e4e8b5

Device Description

CER-LP PROCESS DISPOSABLE PACK PN: 69001-01M

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: Yes
• 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: No
• 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
MUU	System, Suction, Lipoplasty	General, Plastic Surgery	878.5040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63046	Autologous adipose tissue collection/injection set	A collection of sterile devices intended for both harvesting fat tissue from a patient and subsequently injecting the fat tissue into the patient from which it was taken (autologous) for aesthetic body contouring during reconstructive/cosmetic surgery. It typically consists of various needles/cannulae, syringes, and accessories (e.g., caps, connectors). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850023741575	GS1	BOX	15	Not in Commercial Distribution	2022-09-14
Primary	00850023741578	GS1
Package	10858690006805	GS1	Inner Box	1	Not in Commercial Distribution	2022-09-14
Package	20858690006802	GS1	Case	12	Not in Commercial Distribution	2022-09-14

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K150156	000

Device Sizes

Type	Value	Unit	Text
Total Volume	40	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 68 – 77 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Avoid excessive heat. Protect from freezing. Protect from direct sunlight.