ULTRAFIX RC 10175

GUDID 20845854015657

ULTRAFIX RC STITCHPAK , SUTURE ANCHOR WITH ATTACHED No. 2 (5MM) POLYESTER SUTURE, ROTATOR CUFF

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 Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID20845854015657
NIH Device Record Key7e63b129-74ce-4d2a-b154-699238a2157e
Commercial Distribution StatusIn Commercial Distribution
Brand NameULTRAFIX RC
Version Model Number10175
Catalog Number10175
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
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 Diameter2.9 Millimeter
Outer Diameter2.9 Millimeter
Outer Diameter2.9 Millimeter
Outer Diameter2.9 Millimeter
Outer Diameter2.9 Millimeter
Outer Diameter2.9 Millimeter
Outer Diameter2.9 Millimeter
Outer Diameter2.9 Millimeter
Outer Diameter2.9 Millimeter
Outer Diameter2.9 Millimeter
Outer Diameter2.9 Millimeter
Outer Diameter2.9 Millimeter
Outer Diameter2.9 Millimeter
Outer Diameter2.9 Millimeter
Outer Diameter2.9 Millimeter
Outer Diameter2.9 Millimeter
Outer Diameter2.9 Millimeter
Outer Diameter2.9 Millimeter
Outer Diameter2.9 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
GS120845854015657 [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 RC]

20845854040291ULTRAFIX RC SUTURE ANCHOR, ROTATOR CUFF
20845854040284ULTRAFIX RC SUTURE ANCHOR AND DISPOSABLE INSERTER
10845854037096ULTRAFIX RC SUTURE ANCHOR, ROTATOR CUFF, 5 EA
10845854015971ULTRAFIX RC STITCHPAK, SUTURE ANCHOR WITH ATTACHED #2 (5MM) POLYESTER SUTURE, ROTATOR CUFF, 5 EA
20845854015657ULTRAFIX RC STITCHPAK , SUTURE ANCHOR WITH ATTACHED No. 2 (5MM) POLYESTER SUTURE, ROTATOR CUFF

Trademark Results [ULTRAFIX RC]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ULTRAFIX RC
ULTRAFIX RC
75216995 2182910 Live/Registered
CONMED CORPORATION
1996-12-23
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.