ULTRAFIX MINIMITE 10215A

GUDID 10845854016251

ULTRAFIX MINIMITE STITCHPAK, SUTURE ANCHOR WITH ATTACHED #2 (5MM) POLYESTER SUTURE, 5 EA

Conmed Corporation

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID10845854016251
NIH Device Record Key8dcfd75f-e368-479f-ae6f-1a44ad9ba60a
Commercial Distribution StatusIn Commercial Distribution
Brand NameULTRAFIX MINIMITE
Version Model Number10215A
Catalog Number10215A
Company DUNS071595540
Company NameConmed Corporation
Device Count5
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
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
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 Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 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
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY

Device Identifiers

Device Issuing AgencyDevice ID
GS100845854016254 [Unit of Use]
GS110845854016251 [Package]
Contains: 20845854016258
Package: BOX [5 Units]
In Commercial Distribution
GS120845854016258 [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 [ULTRAFIX MINIMITE]

20845854040314ULTRAFIX MINIMITE STITCHPAK, SUTURE ANCHOR WITH ATTACHED #2 (5MM) POLYESTER SUTURE
20845854040307ULTRAFIX MINIMITE, SUTURE ANCHOR
10845854016251ULTRAFIX MINIMITE STITCHPAK, SUTURE ANCHOR WITH ATTACHED #2 (5MM) POLYESTER SUTURE, 5 EA

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