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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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OnPoint Reusable Instrument Kit #2 with 2 Fixed Adapters, 2 Rotating Adapters, and 2 Power Adapters
OnPoint Surgical, Inc.
1
In Commercial Distribution

  • 00850051682201 ()
TK0210201

  • Orthopaedic stereotactic surgery system
Custom Suture Pack, (4) 8886196752, (2) 8886326062, (3) CL953, (2) CL974, (1) S317, (3) SM5627, (2) VP521X, (2) VP522X, (2) VP581X
Covidien LP
US1738
Not in Commercial Distribution

  • 20884521746814 ()
  • 10884521746817 ()


  • Suture kit, medicated
Custom Suture Pack,(1) 88861967-52;(2) 88863182-51;(2) CL-801;(2) CL-803;(5) GS-834;(1) S-243;(1) S-318;(2) SM-691;(2) SN-775
Covidien LP
US1547
Not in Commercial Distribution

  • 20884521160856 ()
  • 10884521160859 ()


  • Suture kit, medicated
(4) 88862631-51;(2) 88863256-51;(3) 88863260-62;(2) CL-813;(1) CL-904;(2) CLS-843;(1) CLS-954;(1) S-305;(1) S-317;(2) SL-5679;(2) VP-511-X;(2) VP-556-X;(4) VP-557-X
Covidien LP
US1501
Not in Commercial Distribution

  • 20884521160610 ()
  • 10884521160613 ()


  • Suture kit, medicated
(3) 88863167-51;(2) 88863205-61;(2) CL-865;(2) CS-793;(1) S-246;(1) S-317;(2) SL-642;(1) SS-648;(1) VP-556-X;(1) VP-557-X;(2) VP-707-X;(2) VP-735-X;(1) VP-977
Covidien LP
US1469
Not in Commercial Distribution

  • 20884521160450 ()
  • 10884521160453 ()


  • Suture kit, medicated
Custom Suture Pack,(1) 88863008-31;(2) 88863090-61;(2) CL-925;(1) GL-127;(2) S-608;(2) SL-632;(1) SS-678G;(2) VLOCL0023;(1) VP-75-X;(4) VP-76-X;(3) VP-521-X;(2) VP-522-X;(3) VP-557-X;(2) VP-872-X
Covidien LP
US1636
Not in Commercial Distribution

  • 20884521174594 ()
  • 10884521174597 ()


  • Suture kit, medicated
Custom Suture Pack,(2) 88863227-51;(3) 88863256-51;(3) CL-843;(2) CL-975;(2) CS-10-M;(1) GS-33-M;(2) S-303;(2) S-305;(1) S-318;(3) SL-613;(4) VP-733-X;(3) VP-772-X;(2) VP-902-X;(2) VP-747-MX
Covidien LP
US1535
Not in Commercial Distribution

  • 20884521160771 ()
  • 10884521160774 ()


  • Suture kit, medicated
Custom Suture Pack,(2) 88863167-41;(2) 88863202-51;(2) CL-924;(4) CL-953;(2) CL-965;(2) GLS-322;(3) GS-66-M;(1) S-317;(2) S-608;(1) VP-522-X;(1) VP-702-MX;(1) VP-720-MX;(1) VP-728-MX;(2) VP-925-X
Covidien LP
US1159
Not in Commercial Distribution

  • 20884521159508 ()
  • 10884521159501 ()


  • Suture kit, medicated
B-P KNEE TIBIA PLATFORM COMPONENT, W/O BIOCOAT, W/ULTRACOAT, TYPE 2, SIZE 2
ENDOTEC, INC.
04-32-0412
Not in Commercial Distribution

  • 00814193021397 ()

  • SIZE 2, TYPE 2
04-32-0412

  • Cruciate-retaining total knee prosthesis
B-P KNEE THICK MODULAR TIBIAL PLATFORM W/SCREW, W/BIOCOAT, W/ULTRACOAT, TYPE 2, SIZE 2
ENDOTEC, INC.
04-32-0312
Not in Commercial Distribution

  • 00814193021151 ()

  • SIZE 2, TYPE 2
04-32-0312

  • Cruciate-retaining total knee prosthesis
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