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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EVOL®SI, 22mm x 100mm Fixed Port Dilator
Cutting Edge Spine, LLC
CES-293
In Commercial Distribution

  • 00841193122441 ()
CES-293

  • Laparoscopic dilation guide rod
CONICAL OBTURATOR 7MM 100MM
Aesculap AG
EJ807R
In Commercial Distribution

  • 04038653153008 ()

  • Diameter (mm) : 7.000 MM
  • Working length (mm) : 100.000 MM
EJ807R

  • Laparoscopic dilation guide rod
TROCAR TAPERED-TIP 12.5MM 110MM
Aesculap AG
EJ786R
Not in Commercial Distribution

  • 04038653152902 ()

  • Diameter (mm) : 12.500 MM
  • Working length (mm) : 110.000 MM
EJ786R

  • Laparoscopic dilation guide rod
TROCAR TRI-TIP 12.5MM 110MM
Aesculap AG
EJ785R
Not in Commercial Distribution

  • 04038653152896 ()

  • Diameter (mm) : 12.500 MM
  • Working length (mm) : 110.000 MM
EJ785R

  • Laparoscopic dilation guide rod
TROCAR TAPERED-TIP 10MM 150MM
Aesculap AG
EJ766R
Not in Commercial Distribution

  • 04038653152803 ()

  • Diameter (mm) : 10.000 MM
  • Working length (mm) : 150.000 MM
EJ766R

  • Laparoscopic dilation guide rod
TROCAR TAPERED-TIP 10MM 110MM
Aesculap AG
EJ756R
Not in Commercial Distribution

  • 04038653152735 ()

  • Diameter (mm) : 10.000 MM
  • Working length (mm) : 110.000 MM
EJ756R

  • Laparoscopic dilation guide rod
TROCAR TRI-TIP 10MM 110MM
Aesculap AG
EJ755R
Not in Commercial Distribution

  • 04038653152728 ()

  • Diameter (mm) : 10.000 MM
  • Working length (mm) : 110.000 MM
EJ755R

  • Laparoscopic dilation guide rod
TROCAR TRI-TIP 5.5MM 150MM
Aesculap AG
EJ725R
Not in Commercial Distribution

  • 04038653152575 ()

  • Diameter (mm) : 5.500 MM
  • Working length (mm) : 150.000 MM
EJ725R

  • Laparoscopic dilation guide rod
BLUNT CONICAL OBTURATOR 5.5MM110MM LGTH
Aesculap AG
EJ718R
Not in Commercial Distribution

  • 04038653152544 ()

  • Diameter (mm) : 5.500 MM
  • Working length (mm) : 110.000 MM
EJ718R

  • Laparoscopic dilation guide rod
TROCAR TAPERED-TIP 5.5MM 110MM
Aesculap AG
EJ716R
Not in Commercial Distribution

  • 04038653152537 ()

  • Diameter (mm) : 5.500 MM
  • Working length (mm) : 110.000 MM
EJ716R

  • Laparoscopic dilation guide rod
TROCAR TRI-TIP 5.5MM 110MM
Aesculap AG
EJ715R
Not in Commercial Distribution

  • 04038653152520 ()

  • Diameter (mm) : 5.500 MM
  • Working length (mm) : 110.000 MM
EJ715R

  • Laparoscopic dilation guide rod
TROCAR TRI-TIP 5.5MM 60MM
Aesculap AG
EJ705R
Not in Commercial Distribution

  • 04038653152445 ()

  • Diameter (mm) : 5.500 MM
  • Working length (mm) : 60.000 MM
EJ705R

  • Laparoscopic dilation guide rod
BLUNT CONICAL OBTURATOR D:10/110MM
Aesculap AG
EJ558R
Not in Commercial Distribution

  • 04038653152278 ()

  • Working length (mm) : 110.000 MM
  • Diameter (mm) : 10.000 MM
EJ558R

  • Laparoscopic dilation guide rod
Integra® Jarit® Dilation Set, 5-10mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
600475
In Commercial Distribution

  • M2746004751 ()
  • 10381780145653 ()
600-475

  • Laparoscopic dilation guide rod
GUIDE TUBE, CURVED, Ø 5 MM (FIT FOR T.0038.05)
Gimmi GmbH
T.0040.05
In Commercial Distribution

  • 04049047546184 ()
T.0040.05

  • Laparoscopic dilation guide rod
CONICAL OBTURATOR BLUNT D:13MM 110MM
Aesculap AG
EJ588R
In Commercial Distribution

  • 04046963075576 ()

  • Diameter (mm) : 13.000 MM
  • Working length (mm) : 110.000 MM
EJ588R

  • Laparoscopic dilation guide rod
CONICAL OBTURATOR SHARP D:13MM 110MM
Aesculap AG
EJ587R
Not in Commercial Distribution

  • 04046963075545 ()

  • Diameter (mm) : 13.000 MM
  • Working length (mm) : 110.000 MM
EJ587R

  • Laparoscopic dilation guide rod
TRIANGULAR OBTURATOR D:13MM 110MM
Aesculap AG
EJ586R
In Commercial Distribution

  • 04046963075521 ()

  • Diameter (mm) : 13.000 MM
  • Working length (mm) : 110.000 MM
EJ586R

  • Laparoscopic dilation guide rod
ARTHROSCOPIC SWITCH STICK
SONTEC INSTRUMENTS, INC.
1271-117-3
In Commercial Distribution

  • 00192896056626 ()

  • 3.7 Millimeter Tip
  • Length: 8 Inch
1271-117-3

  • Laparoscopic dilation guide rod
ARTHROSCOPIC SWITCH STICK
SONTEC INSTRUMENTS, INC.
1271-117-2
In Commercial Distribution

  • 00192896056619 ()

  • Length: 8 Inch
  • 2.9 Millimeter Tip
1271-117-2

  • Laparoscopic dilation guide rod
ARTHROSCOPIC SWITCH STICK
SONTEC INSTRUMENTS, INC.
1271-117-1
In Commercial Distribution

  • 00192896056602 ()

  • Length: 8 Inch
  • 1.1 Millimeter Tip
1271-117-1

  • Laparoscopic dilation guide rod
ARTHROSCOPIC SWITCH STICK
SONTEC INSTRUMENTS, INC.
1271-117
In Commercial Distribution

  • 00192896056596 ()

  • Length: 8 Inch
  • 3.2 Millimeter Tip
1271-117

  • Laparoscopic dilation guide rod
TROCAR PIN CONICAL BLUNT 3.5/110MM
Aesculap AG
EK349R
In Commercial Distribution

  • 04046963575496 ()

  • Diameter (mm) : 3.500 MM
  • Working length (mm) : 110.000 MM
EK349R

  • Laparoscopic dilation guide rod
TROCAR PIN CONICAL BLUNT 3.5/60MM
Aesculap AG
EK348R
In Commercial Distribution

  • 04046963575489 ()

  • Diameter (mm) : 3.500 MM
  • Working length (mm) : 60.000 MM
EK348R

  • Laparoscopic dilation guide rod
TROCAR PIN CONICAL SHARP 3.5/110MM
Aesculap AG
EK346R
In Commercial Distribution

  • 04046963575472 ()

  • Diameter (mm) : 3.500 MM
  • Working length (mm) : 110.000 MM
EK346R

  • Laparoscopic dilation guide rod
TROCAR PIN CONICAL SHARP 3.5/60MM
Aesculap AG
EK345R
In Commercial Distribution

  • 04046963575465 ()

  • Diameter (mm) : 3.500 MM
  • Working length (mm) : 60.000 MM
EK345R

  • Laparoscopic dilation guide rod
ARTHROSCOPIC SWITCH STICK
SONTEC INSTRUMENTS, INC.
1271-117-5
In Commercial Distribution

  • 00192896083981 ()

  • Length: 8.75 Inch
  • 2.4 Millimeter Tip
1271-117-5

  • Laparoscopic dilation guide rod
Talymed 10 cm x 10 cm
Marine Polymer Technologies, Inc.
400-19
In Commercial Distribution

  • 10389142000190 ()
  • 00389142000193 ()


  • Wound regenerating polysaccharide agent
Surface Applicator End Cap, 10 mm, 10-Pack
Icad, Inc.
720297
In Commercial Distribution

  • 00858012005410 ()
SK3510

  • Intraoperative/postoperative therapeutic x-ray system surface applicator
No Description
SCIMEDX CORPORATION
I-HV201X
In Commercial Distribution

  • 00813545025731 ()
I-HV201X

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
SCIMEDX CORPORATION
I-HV101X
In Commercial Distribution

  • 00813545025700 ()
I-HV101X

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
SCIMEDX CORPORATION
I-EBV03X
In Commercial Distribution

  • 00813545025618 ()
I-EBV03X

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Lumipulse G Wash Solution
FUJIREBIO DIAGNOSTICS, INC.
4008248
In Commercial Distribution

  • 00850212007096 ()

  • Size Type = Units Per Kit; Units = 1; Unit of Measure = 1000mLs


  • Buffered wash solution IVD
RESICEM PRIMER B
SHOFU DENTAL CORPORATION
3228
In Commercial Distribution

  • E23532280 ()
3228

  • Dental composite resin
RESICEM PRIMER A
SHOFU DENTAL CORPORATION
3227
In Commercial Distribution

  • E23532270 ()
3227

  • Dental composite resin
RESICEM PASTE 5ml
SHOFU DENTAL CORPORATION
3221
In Commercial Distribution

  • E23532210 ()
3221

  • Dental composite resin
RESICEM BASIC SET
SHOFU DENTAL CORPORATION
3220
In Commercial Distribution

  • E23532200 ()
3220

  • Dental composite resin
PRG BARRIER COAT
SHOFU DENTAL CORPORATION
1795
In Commercial Distribution

  • E23517950 ()
1795

  • Dental coating, tooth-desensitizing, professional
PRG BARRIER COAT MINI KIT
SHOFU DENTAL CORPORATION
1786
In Commercial Distribution

  • E23517860 ()
1786

  • Dental coating, tooth-desensitizing, professional
PRG BARRIER COAT SET BOTTLE TYPE
SHOFU DENTAL CORPORATION
Y2910
In Commercial Distribution

  • E235Y29100 ()
Y2910

  • Dental coating, tooth-desensitizing, professional
No Description
FUJIREBIO INC.
260340
In Commercial Distribution

  • 04987270260340 ()

  • Number of tests per kit: 42


  • SARS-CoV-2 antigen IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235393
In Commercial Distribution

  • 04987270235393 ()

  • Size Type = Tests per Kit; Size Unit = 42; Unit of Measure = Tests


  • Total testosterone IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235294
Not in Commercial Distribution

  • 04987270235294 ()

  • Size Type = Tests per Kit; Size Unit = 42; Unit of Measure = Tests


  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235270
Not in Commercial Distribution

  • 04987270235270 ()

  • Size Type = Tests per Kit; Size Unit = 42; Unit of Measure = Tests


  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235256
Not in Commercial Distribution

  • 04987270235256 ()

  • Size Type = Tests per Kit; Size Unit = 42; Unit of Measure = Tests


  • Progesterone IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235232
In Commercial Distribution

  • 04987270235232 ()

  • Size Type = Tests per Kit; Size Unit = 42; Unit of Measure = Tests


  • Human chorionic gonadotropin beta-core fragment IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235218
Not in Commercial Distribution

  • 04987270235218 ()

  • Size Type = Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235195
Not in Commercial Distribution

  • 04987270235195 ()

  • Size Type = Tests per Kit; Size Unit = 42; Unit of Measure = Tests


  • Prolactin IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235171
In Commercial Distribution

  • 04987270235171 ()

  • Size Type = Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235157
In Commercial Distribution

  • 04987270235157 ()

  • Size Type = Tests Per kit; Size Unit = 42; Unit of Measure = Tests


  • Soluble mesothelin-related peptide (SMRP) IVD, kit, chemiluminescent immunoassay
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