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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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iTotal® CR iPoly® XE Insert Kit - M572RCR020000G131

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

Microfill SuperBrite Kit - D7796011053

Microfill SuperBrite Kit includes 5 (4 g) Microfill SuperBrite syringes in the Tray.
COSMEDENT, INC.
601105
In Commercial Distribution

  • D7796011053 ()
601105

  • Dental composite resin

Microhybrid SuperBrite Kit - D7796130053

Microhybrid SuperBrite Kit includes 5 (5 g) Microhybrid SuperBrite syringes in the Tray.
COSMEDENT, INC.
613005
In Commercial Distribution

  • D7796130053 ()
613005

  • Dental composite resin

Renamel Gingafill Kit - D7796090053

Renamel Gingafill Kit includes 5 (3.5 g) Renamel Gingafill syringes in the Tray.
COSMEDENT, INC.
609005
In Commercial Distribution

  • D7796090053 ()
609005

  • Dental composite resin

Surgical Direct - B382SD14138210

5mm 36cm Atraumatic Grasper, with Diamond Serrations, Non-Locking Reinforced, Carbon Fiber Comfort G
Surgical Direct, Inc.
SD14138-21
In Commercial Distribution

  • B382SD14138210 ()
SD14138-21

  • Flexible endoscopic tissue manipulation forceps, single-use

HELMUT ZEPF - EZPF19274130

REPLACEM.KIT F. CROWN TRACTOR/REMOVER: 40 PLASTIC-POLYMER TIPS, 10 G DIATRAC ADHESIVE POWDER
Helmut Zepf Medizintechnik GmbH
19.274.13
In Commercial Distribution

  • EZPF19274130 ()
19.274.13

  • Dental prosthesis removal instrument

Ena HFO ® - EMICEHTUD31

Ena HFO Dentin UD3 12 tips x 0.3 g each Light Curing Composite
MICERIUM SPA
EHTUD3
In Commercial Distribution

  • EMICEHTUD31 ()
  • EMICCOSVITU30 ()

  • Weight: 3.6 Gram
EHTUD3

  • Dental composite resin

Ena HRI ® - EMICEHRTUE31

Ena HRi Enamel UE3 12 tips x 0.3 g each Light Curing Composite
MICERIUM SPA
EHRTUE3
In Commercial Distribution

  • EMICEHRTUE31 ()
  • EMICCOSVITUE30 ()

  • Weight: 3.6 Gram
EHRTUE3

  • Dental composite resin

Ena HRI ® - EMICEHRTUE21

Ena HRi Enamel UE2 12 tips x 0.3 g each Light Curing Composite
MICERIUM SPA
EHRTUE2
In Commercial Distribution

  • EMICEHRTUE21 ()
  • EMICCOSVITUE20 ()

  • Weight: 3.6 Gram
EHRTUE2

  • Dental composite resin

Ena HRI ® - EMICEHRTUE11

Ena HRi Enamel UE1 12 tips x 0.3 g each Light Curing Composite
MICERIUM SPA
EHRTUE1
In Commercial Distribution

  • EMICEHRTUE11 ()
  • EMICCOSVITUE10 ()

  • Weight: 3.6 Gram
EHRTUE1

  • Dental composite resin
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