FlexGuard Fiber with Sheath

GUDID B14527750200U13FS1

200 micrometer FlexGuard Fiber with Sheath

OPTICAL INTEGRITY INC

General/multiple surgical laser system beam guide, reusable

Primary Device ID	B14527750200U13FS1
NIH Device Record Key	22a2b29c-cdc0-48e9-a2b1-440c925e2281
Commercial Distribution Discontinuation	2017-03-28
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	FlexGuard Fiber with Sheath
Version Model Number	27750200U1FS
Company DUNS	024050887
Company Name	OPTICAL INTEGRITY INC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(850)233-5512
Email	customercare@opticalintegrity.
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com
Phone	+1(850)233-5512
Email	customercare@opticalintegrity.com

Device Dimensions

Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer
Device Size Text, specify	0
Outer Diameter	200 Micrometer

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *store at room temperature
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B14527750200U13FS1 [Package] Contains: B14527750200U1FS0 Package: box [3 Units] Discontinued: 2017-03-28 Not in Commercial Distribution
HIBCC	B14527750200U1FS0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K100194

FDA Product Code

GEX	Powered laser surgical instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

[B14527750200U13FS1]

Ethylene Oxide

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2018-07-06
Device Publish Date	2016-07-28

On-Brand Devices [FlexGuard Fiber with Sheath]

B14527750300U13FS1	300 micrometer FlexGuard Fiber with Sheath
B14527750272U13FS1	272 micrometer FlexGuard Fiber with Sheath
B14527750200U13FS1	200 micrometer FlexGuard Fiber with Sheath