Cytoflex Mesh C02-4101

GUDID D767C0241010

Cytoflex® Mesh is made of pure implantable Titanium with a precision mesh profile. This product is designed for use to ensure three-dimensional reconstruction of alveolar bone defects and to facilitate bone augmentation through adequate fixation of the augmentation material. The thin, supple mesh conforms easily to tissue contours, and yet presents sufficient stiffness to maintain space over the bony defect.

UNICARE BIOMEDICAL INC.

Dental bone matrix implant, metallic
Primary Device IDD767C0241010
NIH Device Record Key75ce23df-4138-479e-b814-e98b6ac9ee5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCytoflex Mesh
Version Model NumberM4-100
Catalog NumberC02-4101
Company DUNS038023573
Company NameUNICARE BIOMEDICAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, well ventilated environment. Keep out of sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD767C0241010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JEYPlate, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-07-27
Device Publish Date2016-11-23

On-Brand Devices [Cytoflex Mesh]

D767C0245010Cytoflex® Mesh is made of pure implantable Titanium with a precision mesh profile. This product
D767C0244010Cytoflex® Mesh is made of pure implantable Titanium with a precision mesh profile. This product
D767C0241010Cytoflex® Mesh is made of pure implantable Titanium with a precision mesh profile. This product
D767C0243010Cytoflex® Mesh is made of pure implantable Titanium with a precision mesh profile. This product
D767C0242010Cytoflex® Mesh is made of pure implantable Titanium with a precision mesh profile. This product

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