SUPER REVO CF6140HB

GUDID 20845854042516

5.0MM SUPER REVO-FT SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) HI-FI SUTURES

Conmed Corporation

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID20845854042516
NIH Device Record Key96f2fd65-de02-480a-9f27-3876595d6aa1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSUPER REVO
Version Model NumberCF6140HB
Catalog NumberCF6140HB
Company DUNS071595540
Company NameConmed Corporation
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

Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com

Device Dimensions

Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY

Device Identifiers

Device Issuing AgencyDevice ID
GS110845854042519 [Package]
Package: Carton [1 Units]
In Commercial Distribution
GS120845854042516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-03-21
Device Publish Date2015-10-24

On-Brand Devices [SUPER REVO]

20845854042530SUPER REVO-FT 5.0MM SUTURE ANCHOR W/ 2 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES
208458540425165.0MM SUPER REVO-FT SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) HI-FI SUTURES
208458540198225MM SUPER REVO ANCHOR, PRETHREADED, NO. 2 HIFI
208458540198155MM SUPER REVO IMPLANT ONLY, TWO USP NO. 2 BRAIDED SUTURES
20845854018948SUPER REVO-FT 5.0MM SUTURE ANCHOR W/ 2 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES
208458540158485MM SUPER REVO WITH DISPOSABLE DRIVER, TWO NO. 2 HI-FI SUTURES
208458540142545.0MM THREVO-FT SUTURE ANCHOR WITH THREE NO. 2 (5 METRIC) HI-FI SUTURES
208458540134625.0MM SUPER REVO-FT SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) HI-FI SUTURES
208458540123115MM SUPER REVO WITH DISPOSABLE DRIVER, TWO USP NO. 2 BRAIDED SUTURES
10845854030844SUPER REVO REUSABLE DRIVER
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