GENESYS PRESSFT, HI-FI NB212

GUDID 10845854027875

GENESYS PRESSFT 2.1 W/TWO #0 (3.5 METRIC) HI-FI SUTURES (1 WHITE/BLACK AND 1 WHITE/BLUE)

Conmed Corporation

Tendon/ligament bone anchor, bioabsorbable

Primary Device ID	10845854027875
NIH Device Record Key	5808e8ed-b3e9-4938-81ea-828d4baa4e9d
Commercial Distribution Status	In Commercial Distribution
Brand Name	GENESYS PRESSFT, HI-FI
Version Model Number	NB212
Catalog Number	NB212
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(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM

Device Dimensions

Outer Diameter	2.1 Millimeter
Outer Diameter	2.1 Millimeter
Outer Diameter	2.1 Millimeter
Outer Diameter	2.1 Millimeter
Outer Diameter	2.1 Millimeter
Outer Diameter	2.1 Millimeter
Outer Diameter	2.1 Millimeter
Outer Diameter	2.1 Millimeter
Outer Diameter	2.1 Millimeter
Outer Diameter	2.1 Millimeter
Outer Diameter	2.1 Millimeter
Outer Diameter	2.1 Millimeter
Outer Diameter	2.1 Millimeter
Outer Diameter	2.1 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10845854027875 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K121890

FDA Product Code

MAI	FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	6
Public Version Date	2024-08-13
Device Publish Date	2015-10-24

On-Brand Devices [GENESYS PRESSFT, HI-FI]

30845854027893	GENESYS PressFT 2.6 w/One #2 (5 metric) Hi-Fi Suture, HIP (1 White/Black)
30845854027862	GENESYS PressFT 2.1 w/One #2 (5 metric) Hi-Fi Suture, HIP (1 White/Black)
10845854027905	GENESYS PRESSFT 2.6 W/TWO #1 (4 METRIC) HI-FI SUTURES (1 WHITE/BLACK AND 1 WHITE/BLUE)
10845854027882	GENESYS PRESSFT 2.6 W/ONE #2 (5 METRIC) HI-FI SUTURE (1 WHITE/BLACK)
10845854027875	GENESYS PRESSFT 2.1 W/TWO #0 (3.5 METRIC) HI-FI SUTURES (1 WHITE/BLACK AND 1 WHITE/BLUE)
10845854027851	GENESYS PRESSFT 2.1 W/ONE #2 (5 METRIC) HI-FI SUTURE (1 WHITE/BLACK)