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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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24G x 9mm x 6" Clear-View "Sub-Q" Infusion Set
NORFOLK MEDICAL
Clear-View "Sub-Q"
In Commercial Distribution

  • M991CVS022303 ()
  • M991CVS022302 ()
  • M991CVS022301 ()

  • Needle Gauge: 24 Gauge
CVS02230

  • Electric infusion pump administration set, single-use
24G x 6mm x 6" Clear-View "Sub-Q" Infusion Set
NORFOLK MEDICAL
Clear-View "Sub-Q"
In Commercial Distribution

  • M991CVS021301 ()
  • M991CVS021302 ()
  • M991CVS021303 ()

  • Needle Gauge: 24 Gauge
CVS02130

  • Electric infusion pump administration set, single-use
ProChem B-D Bowie Dick Type Test pack
MESA LABORATORIES, INC.
ProChem
In Commercial Distribution

  • M985CIBDTLF0 ()
  • M985CIBDTLF2 ()
  • M985CIBDTLF1 ()
CI-BDTLF

  • Chemical/physical sterilization process indicator
pHoenix Dialysate Meter
MESA LABORATORIES, INC.
06.500321
In Commercial Distribution

  • M985065003210 ()
  • M9850600030 ()
  • M9850600390 ()
06.500321

  • Multi-parameter device tester
RAN-1115H2S C#0002262 PN 74290-01M
RANFAC CORP.
11 Gauge X 15.24CM
In Commercial Distribution

  • M979G65X9 ()
  • M979G65X1 ()
  • M979G65X0 ()

  • Needle Gauge: 11 Gauge
  • Length: 15.24 Centimeter
G65X

  • Bone access cannula
CELLXTRACT Autologous Cell and Bone Marrow Extraction CXT1145S 11GA X 11CM C#0002262 P/N 74271-02M
RANFAC CORP.
CXT1145S 11GA X 11CM
In Commercial Distribution

  • M979CXT1145S9 ()
  • M979CXT1145S1 ()
  • M979CXT1145S0 ()

  • Length: 11 Centimeter
  • Needle Gauge: 11 Gauge
CXT1145S

  • Bone access cannula
NDL, RBN-84, STERILE, F/G PN 74050-06M
RANFAC CORP.
8 GAUGE x 4"
In Commercial Distribution

  • M9797405006M0 ()
  • M9797405006M1 ()
  • M9797405006M9 ()

  • Length: 4 Inch
  • Needle Gauge: 8 Gauge
RBN-84

  • Bone marrow biopsy needle, single-use
NDL, RBN-132, STERILE, F/G
RANFAC CORP.
13 GAUGE x 2"
In Commercial Distribution

  • M9797405005M9 ()
  • M9797405005M1 ()
  • M9797405005M0 ()

  • Needle Gauge: 13 Gauge
  • Length: 2 Inch
RBN-132

  • Bone marrow biopsy needle, single-use
NDL, RBN-133, STERILE, F/G PN 74050-03M
RANFAC CORP.
13 GAUGE x 3"
In Commercial Distribution

  • M9797405003M9 ()
  • M9797405003M1 ()
  • M9797405003M0 ()

  • Needle Gauge: 13 Gauge
  • Length: 3 Inch
RBN-133

  • Bone marrow biopsy needle, single-use
NDL, RBN-114, STERILE, F/G PN 74050-01M
RANFAC CORP.
11 GAUGE x 4"
In Commercial Distribution

  • M9797405001M9 ()
  • M9797405001M1 ()
  • M9797405001M0 ()

  • Length: 4 Inch
  • Needle Gauge: 11 Gauge
RBN-114

  • Bone marrow biopsy needle, single-use
ORC-A, F/G ASSY, RANFAC, 20 GA PN 68085-01M
RANFAC CORP.
20 GAUGE
In Commercial Distribution

  • M9796808501M9 ()
  • M9796808501M1 ()
  • M9796808501M0 ()

  • Needle Gauge: 20 Gauge
ORC-A-20

  • Rigid endoscopic cannula, single-use
ORC-A, F/G ASSY, RANFAC, 18 GA PN 68084-01M
RANFAC CORP.
18 GAUGE
In Commercial Distribution

  • M9796808401M9 ()
  • M9796808401M1 ()
  • M9796808401M0 ()

  • Needle Gauge: 18 Gauge
ORC-A-18

  • Rigid endoscopic cannula, single-use
GALACTOGRAPHY STRAIGHT INFUSION, 31 GA, 31G-END PN68008-07M
RANFAC CORP.
31 Gauge
In Commercial Distribution

  • M9796800807M9 ()
  • M9796800807M1 ()
  • M9796800807M0 ()

  • Needle Gauge: 31 Gauge
31G-END

  • Breast ductography cannula
GALACTOGRAPHY INFUSION, 31 GA GIU-31 PN 68008-06M
RANFAC CORP.
31 GAUGE
In Commercial Distribution

  • M9796800806M9 ()
  • M9796800806M1 ()
  • M9796800806M0 ()

  • Needle Gauge: 31 Gauge
GIU-31

  • Breast ductography cannula
GALACTOGRAPHY INFUSION, 30 GA GIU-30
RANFAC CORP.
30 GAUGE
In Commercial Distribution

  • M9796800805M9 ()
  • M9796800805M1 ()
  • M9796800805M0 ()

  • Needle Gauge: 30 Gauge
GIU-30

  • Breast ductography cannula
SIALOGRAPHY UNIT ENDPORT, 30GA 30G-END PN 68008-03M
RANFAC CORP.
30 Gauge
In Commercial Distribution

  • M9796800803M9 ()
  • M9796800803M1 ()
  • M9796800803M0 ()

  • Needle Gauge: 30 Gauge
30G-END

  • Salivary gland catheter
RANFAC BREAST MRK, 7.5CM F/G SBS-7.5 PN 60004-03M
RANFAC CORP.
7.5 CM
In Commercial Distribution

  • M9796000403M9 ()
  • M9796000403M1 ()
  • M9796000403M0 ()

  • Length: 7.5 Centimeter
SBS-7.5

  • Needle guide, single-use
RANFAC BREAST MRK, 10CM F/G SBS-10 PN 60004-02M
RANFAC CORP.
10CM
In Commercial Distribution

  • M9796000402M9 ()
  • M9796000402M1 ()
  • M9796000402M0 ()

  • Length: 10 Centimeter
SBS-10

  • Needle guide, single-use
RANFAC BREAST MRK, 5CM F/G SBS-5 PN 60004-01M
RANFAC CORP.
5CM
In Commercial Distribution

  • M9796000401M9 ()
  • M9796000401M1 ()
  • M9796000401M0 ()

  • Length: 5 Centimeter
SBS-5

  • Needle guide, single-use
Disposable breath alcohol test
Alcopro Inc.
CP08
In Commercial Distribution

  • G354CCP082002 ()
  • G354CCP082001 ()
  • G354CCP082003 ()
  • G354CCP082000 ()
CCP08200

  • Alcohol breath analyser
Disposable breath alcohol test
Alcopro Inc.
CP04
In Commercial Distribution

  • G354CCP042002 ()
  • G354CCP042001 ()
  • G354CCP042003 ()
  • G354CCP042000 ()
CCP04200

  • Alcohol breath analyser
Disposable breath alcohol test
Alcopro Inc.
CP02
In Commercial Distribution

  • G354CCP022001 ()
  • G354CCP022002 ()
  • G354CCP022003 ()
  • G354CCP022000 ()
CCP02200

  • Alcohol breath analyser
Single-Use Steerable Basket
EndoTheia, Inc.
FSA-120-21
In Commercial Distribution

  • G380FSA120210 ()
  • G380FSA120211 ()
  • G380FSA120212 ()


  • Urinary stone retrieval basket, single-use
HR Wide angle lens Consultation
PHAKOS
MV LV 41 HR
In Commercial Distribution

  • B564MVLV41HR2 ()
  • B564MVLV41HR0 ()
  • B564MVLV41HR4 ()
MV LV 41 HR

  • Vitrectomy contact lens, single-use
Disposable Retinal Cryo Probe
PHAKOS
MV CY 100
In Commercial Distribution

  • B564MVCY1000 ()
  • B564MVCY1002 ()
  • B564MVCY1004 ()
MV CY 100

  • General cryosurgical system, cryogen gas, mechanical
MACINTOSH Laryngoscope blade fig 4, conventional with LED and medium plastic handle combination, battery included, single patient use, non-sterile, metal flap, working length (139 mm) (pack of 10)
Carnegie Surgical LLC
404-6648
In Commercial Distribution

  • G14140466481 ()
  • G14140466480 ()
  • G14140466482 ()
404-6648

  • Rigid intubation laryngoscope, single-use
MACINTOSH Laryngoscope blade fig 4, conventional with LED and small plastic handle combination, battery included, single patient use, non-sterile, metal flap, working length (139 mm) (pack of 10)
Carnegie Surgical LLC
404-6647
In Commercial Distribution

  • G14140466471 ()
  • G14140466470 ()
  • G14140466472 ()
404-6647

  • Rigid intubation laryngoscope, single-use
MACINTOSH Laryngoscope blade fig 3.5, conventional with LED and medium plastic handle combination, battery included, single patient use, non-sterile, metal flap, working length (131 mm) (pack of 10)
Carnegie Surgical LLC
404-66385
In Commercial Distribution

  • G141404663851 ()
  • G141404663850 ()
  • G141404663852 ()
404-66385

  • Rigid intubation laryngoscope, single-use
MACINTOSH Laryngoscope blade fig 3, conventional with LED and medium plastic handle combination, battery included, single patient use, non-sterile, metal flap, working length (111 mm) (pack of 10)
Carnegie Surgical LLC
404-6638
In Commercial Distribution

  • G14140466381 ()
  • G14140466380 ()
  • G14140466382 ()
404-6638

  • Rigid intubation laryngoscope, single-use
MACINTOSH Laryngoscope blade fig 3, conventional with LED and small plastic handle combination, battery included, single patient use, non-sterile, metal flap, working length (111 mm) (pack of 10)
Carnegie Surgical LLC
404-6637
In Commercial Distribution

  • G14140466371 ()
  • G14140466370 ()
  • G14140466372 ()
404-6637

  • Rigid intubation laryngoscope, single-use
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