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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N/A
Conformis, Inc.
RCR101111201
In Commercial Distribution

  • M572RCR1011112011 ()

  • Patient Specific
RCR1011112

  • Total knee prosthesis implantation guide-instrument kit
  • Uncoated knee femur prosthesis, metallic
ITOTAL CR IPOLY XE LATERAL F INSERT KIT LEFT or right NO TRIAL
Conformis, Inc.
RCR020000F13
In Commercial Distribution

  • M572RCR020000F131 ()

  • Patient Specific
RCR020000F

  • Tibial insert
N/A
Conformis, Inc.
RCR010000K13
In Commercial Distribution

  • M572RCR010000K131 ()

  • Patient Specific
RCR010000K

  • Tibial insert
N/A
Conformis, Inc.
RCR010000J13
In Commercial Distribution

  • M572RCR010000J131 ()

  • Patient Specific
RCR010000J

  • Tibial insert
N/A
Conformis, Inc.
RCR010000I13
In Commercial Distribution

  • M572RCR010000I131 ()

  • Patient Specific
RCR010000I

  • Tibial insert
N/A
Conformis, Inc.
RCR010000H13
In Commercial Distribution

  • M572RCR010000H131 ()

  • Patient Specific
RCR010000H

  • Tibial insert
N/A
Conformis, Inc.
RCR010000G13
In Commercial Distribution

  • M572RCR010000G131 ()

  • Patient Specific
RCR010000G

  • Tibial insert
N/A
Conformis, Inc.
RCR010000E13
In Commercial Distribution

  • M572RCR010000E131 ()

  • Patient Specific
RCR010000E

  • Tibial insert
N/A
Conformis, Inc.
RCR010000D13
In Commercial Distribution

  • M572RCR010000D131 ()

  • Patient Specific
RCR010000D

  • Tibial insert
N/A
Conformis, Inc.
RCR010000A13
In Commercial Distribution

  • M572RCR010000A131 ()

  • Patient Specific
RCR010000A

  • Tibial insert
IDUO–TIBIAL TRAY KIT–LEFT or right MEDIAL or lateral
Conformis, Inc.
RBK101111302
In Commercial Distribution

  • M572RBK1011113021 ()

  • Patient Specific
RBK1011113

  • Bicompartmental knee prosthesis
CR JIGS, LEFT AND RIGHT
Conformis, Inc.
TCR000D00201
In Commercial Distribution

  • M572TCR000D002011 ()

  • Patient Specific
TCR-000-D002

  • Total knee prosthesis implantation guide-instrument kit
N/A
Conformis, Inc.
RUK101111302
In Commercial Distribution

  • M572RUK1011113021 ()

  • Patient Specific
RUK1011113

  • Uncoated unicondylar knee tibia prosthesis, metallic
N/A
Conformis, Inc.
RUK101111301
Not in Commercial Distribution

  • M572RUK1011113011 ()

  • Patient Specific
RUK1011113

  • Uncoated unicondylar knee femur prosthesis
N/A
Conformis, Inc.
RUK101111203
In Commercial Distribution

  • M572RUK1011112031 ()

  • Patient Specific
RUK1011112

  • Uncoated unicondylar knee femur prosthesis
N/A
Conformis, Inc.
RUK101111202
In Commercial Distribution

  • M572RUK1011112021 ()

  • Patient Specific
RUK1011112

  • Uncoated unicondylar knee femur prosthesis
iTotal® Posterior Stabilized (PS) Knee Tibial Kit
Conformis, Inc.
RPS101111302
In Commercial Distribution

  • M572RPS1011113021 ()

  • Patient Specific
RPS1011113

  • Total knee prosthesis implantation guide-instrument kit
  • Uncoated knee tibia prosthesis, metallic
N/A
Conformis, Inc.
RPS101111301
In Commercial Distribution

  • M572RPS1011113011 ()

  • Patient Specific
RPS1011113

  • Total knee prosthesis implantation guide-instrument kit
  • Uncoated knee tibia prosthesis, metallic
iTotal® Posterior Stabilized (PS) Knee Tibial Kit
Conformis, Inc.
RPS101111202
In Commercial Distribution

  • M572RPS1011112021 ()

  • Patient Specific
RPS1011112

  • Total knee prosthesis implantation guide-instrument kit
  • Uncoated knee femur prosthesis, metallic
N/A
Conformis, Inc.
RPS101111201
In Commercial Distribution

  • M572RPS1011112011 ()

  • Patient Specific
RPS1011112

  • Total knee prosthesis implantation guide-instrument kit
  • Uncoated knee femur prosthesis, metallic
ITOTAL CR IPOLY XE LATERAL K INSERT KIT LEFT or right NO TRIAL
Conformis, Inc.
RCR020000K13
In Commercial Distribution

  • M572RCR020000K131 ()

  • Patient Specific
RCR020000K

  • Tibial insert
ITOTAL CR IPOLY XE LATERAL J INSERT KIT LEFT or right NO TRIAL
Conformis, Inc.
RCR020000J13
In Commercial Distribution

  • M572RCR020000J131 ()

  • Patient Specific
RCR020000J

  • Tibial insert
ITOTAL CR IPOLY XE LATERAL I INSERT KIT LEFT or right NO TRIAL
Conformis, Inc.
RCR020000I13
In Commercial Distribution

  • M572RCR020000I131 ()

  • Patient Specific
RCR020000I

  • Tibial insert
N/A
Conformis, Inc.
RCR020000H13
Not in Commercial Distribution

  • M572RCR020000H131 ()

  • Patient Specific
RCR020000H

  • Tibial insert
ITOTAL CR IPOLY XE LATERAL G INSERT KIT LEFT or right NO TRIAL
Conformis, Inc.
RCR020000G13
In Commercial Distribution

  • M572RCR020000G131 ()

  • Patient Specific
RCR020000G

  • Tibial insert
ITOTAL CR IPOLY XE LATERAL E INSERT KIT LEFT NO TRIAL
Conformis, Inc.
RCR020000E13
In Commercial Distribution

  • M572RCR020000E131 ()

  • Patient Specific
RCR020000E

  • Tibial insert
ITOTAL CR IPOLY XE LATERAL D INSERT KIT LEFT NO TRIAL
Conformis, Inc.
RCR020000D13
In Commercial Distribution

  • M572RCR020000D131 ()

  • Patient Specific
RCR020000D

  • Tibial insert
N/A
Conformis, Inc.
RCR020000C13
In Commercial Distribution

  • M572RCR020000C131 ()

  • Patient Specific
RCR020000C

  • Tibial insert
ITOTAL CR IPOLY XE LATERAL B INSERT KIT LEFT or right NO TRIAL
Conformis, Inc.
RCR020000B13
In Commercial Distribution

  • M572RCR020000B131 ()

  • Patient Specific
RCR020000B

  • Tibial insert
ITOTAL CR IPOLY XE LATERAL A INSERT KIT LEFT NO TRIAL
Conformis, Inc.
RCR020000A13
In Commercial Distribution

  • M572RCR020000A131 ()

  • Patient Specific
RCR020000A

  • Tibial insert
N/A
Conformis, Inc.
RCR010000F13
In Commercial Distribution

  • M572RCR010000F131 ()

  • Patient Specific
RCR010000F

  • Tibial insert
N/A
Conformis, Inc.
RCR010000C13
In Commercial Distribution

  • M572RCR010000C131 ()

  • Patient Specific
RCR010000C

  • Tibial insert
N/A
Conformis, Inc.
RCR010000B13
In Commercial Distribution

  • M572RCR010000B131 ()

  • Patient Specific
RCR010000B

  • Tibial insert
N/A
Conformis, Inc.
RBK101111301
Not in Commercial Distribution

  • M572RBK1011113011 ()

  • Patient Specific
RBK1011113

  • Bicompartmental knee prosthesis
N/A
Conformis, Inc.
RBK101111202
Not in Commercial Distribution

  • M572RBK1011112021 ()

  • Patient Specific
RBK1011112

  • Bicompartmental knee prosthesis
No Description
Conformis, Inc.
RBK101111201
Not in Commercial Distribution

  • M572RBK1011112011 ()

  • Patient Specific
RBK1011112

  • Bicompartmental knee prosthesis
No Description
Biomet Orthopedics, LLC
110046598
In Commercial Distribution

  • 00887868555732 ()

  • PATIENT MATCHED
110046598

  • Custom-made organ/bone anatomy model/surgical guide kit
AirLife™ Infant Skin Temperature Probe, Single Patient Use (Lullaby™, Care Plus™)
AirLife Finland Oy
6600-0208-700
In Commercial Distribution

  • 20889483587901 ()
  • 10889483587904 ()
  • 10190752181205 ()
6600-0208-700

  • General-purpose patient temperature probe, single-use
AirLife™ Infant Skin Temperature Probe, Single Patient Use (Lullaby™, Care Plus™)
AirLife Finland Oy
6600-0196-700
In Commercial Distribution

  • 20889483587888 ()
  • 10889483587881 ()
  • 30889483587885 ()
  • 10190752181199 ()
6600-0196-700

  • General-purpose patient temperature probe, single-use
SKIN PACK
MEDLINE INDUSTRIES, INC.
DYNJ57693A
In Commercial Distribution

  • 10888277761742 ()
DYNJ57693A

  • General surgical procedure kit, non-medicated, single-use
Skin Protector
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1023
In Commercial Distribution

  • 05391529582364 ()
INS-1023

  • Orthopaedic implantation sleeve, reusable
SKIN PACK
MEDLINE INDUSTRIES, INC.
DYNJ62181
In Commercial Distribution

  • 10193489636338 ()
  • 40193489636339 ()
DYNJ62181

  • General surgical procedure kit, non-medicated, single-use
SKIN PACK
MEDLINE INDUSTRIES, INC.
DYNJ69232A
In Commercial Distribution

  • 40195327045266 ()
  • 10195327045265 ()
DYNJ69232A

  • General surgical procedure kit, non-medicated, single-use
SKIN ONLY
MEDLINE INDUSTRIES, INC.
DYNJ905666D
In Commercial Distribution

  • 10193489939149 ()
DYNJ905666D

  • General surgical procedure kit, non-medicated, single-use
SKIN PACK
MEDLINE INDUSTRIES, INC.
DYNJ69146
In Commercial Distribution

  • 40193489894012 ()
  • 10193489894011 ()
DYNJ69146

  • General surgical procedure kit, non-medicated, single-use
SKIN PACK
MEDLINE INDUSTRIES, INC.
DYNJ57693C
In Commercial Distribution

  • 10193489943733 ()
  • 40193489943734 ()
DYNJ57693C

  • General surgical procedure kit, non-medicated, single-use
SKIN PACK
MEDLINE INDUSTRIES, INC.
DYNJ57693
In Commercial Distribution

  • 10889942768134 ()
DYNJ57693

  • General surgical procedure kit, non-medicated, single-use
SKIN PACK
MEDLINE INDUSTRIES, INC.
DYNJ57445
In Commercial Distribution

  • 10889942740758 ()
  • 40889942740759 ()
DYNJ57445

  • General surgical procedure kit, non-medicated, single-use
SKIN PACK
MEDLINE INDUSTRIES, INC.
DYNJ902389A
In Commercial Distribution

  • 10889942131181 ()
  • 40889942131182 ()
DYNJ902389A

  • General surgical procedure kit, non-medicated, single-use
SKIN PACK
MEDLINE INDUSTRIES, INC.
DYNJ62181A
In Commercial Distribution

  • 10193489796285 ()
  • 40193489796286 ()
DYNJ62181A

  • General surgical procedure kit, non-medicated, single-use
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