BIO MINI-REVO C6170HP

GUDID 20845854030926

3.1 X 11MM BIO MINI-REVO, PRELOADED WITH ONE SIZE 2 (5 METRIC) HI-FI SUTURE

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
Primary Device ID20845854030926
NIH Device Record Key50518151-f573-4eb5-9e56-77d18cdeb82b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIO MINI-REVO
Version Model NumberC6170HP
Catalog NumberC6170HP
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(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM

Device Dimensions

Outer Diameter3.1 Millimeter
Length11 Millimeter
Outer Diameter3.1 Millimeter
Length11 Millimeter
Outer Diameter3.1 Millimeter
Length11 Millimeter
Outer Diameter3.1 Millimeter
Length11 Millimeter
Outer Diameter3.1 Millimeter
Length11 Millimeter
Outer Diameter3.1 Millimeter
Length11 Millimeter
Outer Diameter3.1 Millimeter
Length11 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween 0 and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween 0 and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween 0 and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween 0 and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween 0 and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS120845854030926 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

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 Date2016-09-24

On-Brand Devices [BIO MINI-REVO]

208458540309263.1 X 11MM BIO MINI-REVO, PRELOADED WITH ONE SIZE 2 (5 METRIC) HI-FI SUTURE
208458540143153.1 X 11MM BIO MINI-REVO, PRELOADED WITH ONE SIZE 2 (5 METRIC) HI-FI SUTURE

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