GENESYS CROSSFT CFBC-4502

GUDID 20845854034566

4.5MM GENESYS CROSSFT SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) HI-FI SUTURES

Conmed Corporation

Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable

Primary Device ID	20845854034566
NIH Device Record Key	53a9344d-ac93-46f7-875e-c0d88b6da4f9
Commercial Distribution Status	In Commercial Distribution
Brand Name	GENESYS CROSSFT
Version Model Number	CFBC-4502
Catalog Number	CFBC-4502
Company DUNS	071595540
Company Name	Conmed Corporation
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	false
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(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com
Phone	+1(866)426-6633
Email	CustomerExperience@conmed.com

Device Dimensions

Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter
Outer Diameter	4.5 Millimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY
Storage Environment Temperature	Between 0 and 40 Degrees Celsius
Storage Environment Temperature	Between 0 and 104 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *KEEP DRY

Device Identifiers

Device Issuing Agency	Device ID
GS1	10845854034569 [Package] Package: Carton [1 Units] In Commercial Distribution
GS1	20845854034566 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K101100

FDA Product Code

MAI	FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

[20845854034566]

Ethylene Oxide

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-03-21
Device Publish Date	2016-09-24

On-Brand Devices [GENESYS CROSSFT]

30845854042483	5.5MM GENESYS CROSSFT SUTURE ANCHOR WITH THREE NO. 2 (5 METRIC) HI-FI SUTURES
20845854042721	GENESYS CROSSFT 6.5MM SUTURE ANCHOR, W/ 3 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES
20845854042714	GENESYS CROSSFT 6.5MM SUTURE ANCHOR, W/ 2 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES
20845854042707	GENESYS CROSSFT 5.5MM SUTURE ANCHOR, W/ 3 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES
20845854042691	GENESYS CROSSFT 5.5MM SUTURE ANCHOR, W/ 2 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES
20845854042684	GENESYS CROSSFT 4.5MM SUTURE ANCHOR, W/ 3 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES
20845854042677	GENESYS CROSSFT 4.5MM SUTURE ANCHOR, W/ 2 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES
20845854042509	6.5MM GENESYS CROSSFT SUTURE ANCHOR WITH THREE NO. 2 (5 METRIC) HI-FI SUTURES
20845854042493	6.5MM GENESYS CROSSFT SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) HI-FI SUTURES
20845854042479	5.5MM GENESYS CROSSFT SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) HI-FI SUTURES
20845854042462	4.5MM GENESYS CROSSFT SUTURE ANCHOR WITH THREE NO. 2 (5 METRIC) HI-FI SUTURES
20845854042455	GENESYS CROSSFT 4.5MM SUTURE ANCHOR, WITH TWO #2 (5METRIC) HI-FI SUTURES
20845854034597	GENESYS CROSSFT 5.5MM SUTURE ANCHOR, W/ 2 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES
20845854034580	GENESYS CROSSFT 4.5MM SUTURE ANCHOR, W/ 3 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES
20845854034573	GENESYS CROSSFT 4.5MM SUTURE ANCHOR, W/ 2 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES
20845854034566	4.5MM GENESYS CROSSFT SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) HI-FI SUTURES
20845854026783	5.5MM GENESYS CROSSFT SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) HI-FI SUTURES
20845854026776	4.5MM GENESYS CROSSFT SUTURE ANCHOR WITH THREE NO. 2 (5 METRIC) HI-FI SUTURES
10845854032664	GENESYS CROSSFT TAP, 6.5MM
10845854032640	GENESYS CROSSFT TAP, 5.5MM
10845854032626	GENESYS CROSSFT TAP, 4.5MM
10845854034620	GENESYS CROSSFT 6.5MM SUTURE ANCHOR, W/ 3 HI-FI #2 (5 METRIC) SUTURES W/NEEDLES
10845854028223	GENESYS CROSSFT PUNCH, 5.5MM
10845854034613	GENESYS CROSSFT 6.5MM SUTURE ANCHOR, W/ 2 HI-FI (5 METRIC) SUTURES W/NEEDLES
10845854034606	GENESYS CROSSFT 5.5MM SUTURES ANCHOR, W/ 3 HI-FI #2 (5 METRIC) SUTURES W/NEEDLES
10845854026816	6.5MM CROSSFT-BC ANCHOR, W/DISP, TRP
10845854026809	6.5MM CROSSFT-BC ANCHOR, W/DISP, DBL
10845854026793	5.5MM CROSSFT-BC ANCHOR, W/DISP, TRP