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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IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0104
In Commercial Distribution

  • 00815381020116 ()
RFIT-ASY-0104

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0116
In Commercial Distribution

  • 00815381020109 ()
RFIT-ASY-0116

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
424898
In Commercial Distribution

  • 00815381020888 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert Norovirus kit; 10 test kit
CEPHEID
GXNOV-10
In Commercial Distribution

  • 07332940000974 ()
GXNOV-10

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Disposable Needle Guides for use with Mindray 65EC10EA, 6CV1(s,P), CB10-4(s,P,E), V10-4(s), V10-4B(s,p), V11-3(E), V11-3B(E), V11-3W(s,E), V11-3H(E,U); Wisonic EV10-4; Landwind EC4-9; Samsung EC4-9IS, EC4-9ES, ER4-9ES; GE IC5-9; VINNO G4-9E, X4-9E; Zoncare 6E1CD Ultrasound Transducers
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
DE-001
In Commercial Distribution

  • 16971554725019 ()
  • 06971554725012 ()
DE-001

  • Needle guide, single-use
CUSTOM PACK CB6Z18R3 1/4 E RP
MEDTRONIC, INC.
CB6Z18R3
In Commercial Distribution

  • 00643169098121 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK TL7G20R3 3/8X1/4 E
MEDTRONIC, INC.
TL7G20R3
In Commercial Distribution

  • 00643169117921 ()


  • Cardiopulmonary bypass system blood tubing set
LITHOTOMY PACK D C, D E PACK
Cardinal Health 200, LLC
SMA11NLNUH
In Commercial Distribution

  • 50888439979457 ()
  • 10888439979459 ()
SMA11NLNUH

  • Obstetrical/gynaecological surgical procedure kit, medicated
312/E/3.30 E-010/012 Curtain (Panels)
KENEX (ELECTRO-MEDICAL) LIMITED
312/E/3.30
In Commercial Distribution

  • 05055449407069 ()
312/E/3.30

  • Radiation shielding curtain
KIT LABOR & DELIVERY D&C/D&E
MEDLINE INDUSTRIES, INC.
DYKMBNDL31
In Commercial Distribution

  • 10193489478716 ()
  • 40193489478717 ()
DYKMBNDL31

  • General surgical procedure kit, non-medicated, single-use
SAIPH Fixed Tibial Tray Cemented Size E
MATORTHO LTD
193-604
In Commercial Distribution

  • 05055455506190 ()
193-604

  • Uncoated knee tibia prosthesis, metallic
CUSTOM PACK CB1L33R31 3/8 RD E
MEDTRONIC, INC.
CB1L33R31
Not in Commercial Distribution

  • 00643169341159 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB5W39R23 1/4 RD E
MEDTRONIC, INC.
CB5W39R23
Not in Commercial Distribution

  • 00643169341142 ()


  • Cardiopulmonary bypass system blood tubing set
9' POLY STRAP CUSTOM E Z LIFT
MORRISON MEDICAL, LTD
1350OREZ-9
In Commercial Distribution

  • 00647921135062 ()
1350OREZ-9

  • Limb/torso/head restraint, reusable
7' POLY STRAP CUSTOM E Z LIFT
MORRISON MEDICAL, LTD
1350OREZ-7
In Commercial Distribution

  • 00647921135055 ()
1350OREZ-7

  • Limb/torso/head restraint, reusable
CUSTOM PACK CB6V93R7 A 3/8 E
MEDTRONIC, INC.
CB6V93R7
Not in Commercial Distribution

  • 00643169657120 ()


  • Cardiopulmonary bypass system blood tubing set
IPS Empress Esthetic Ingot E TC0/5pcs
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574562
Not in Commercial Distribution

  • DIVO5745621 ()
  • DIVO5745620 ()
  • DIVO5745622 ()
574562

  • Dental appliance fabrication material, ceramic
IPS Empress Esthetic Ingot E TC1/5pcs
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574557
Not in Commercial Distribution

  • DIVO5745571 ()
  • DIVO5745570 ()
  • DIVO5745572 ()
574557

  • Dental appliance fabrication material, ceramic
IPS Empress Esthetic Ingot E O1/5pcs
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574555
Not in Commercial Distribution

  • DIVO5745551 ()
  • DIVO5745550 ()
  • DIVO5745552 ()
574555

  • Dental appliance fabrication material, ceramic
IPS Empress Esthetic Ingot E TC0/10pcs
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574520
Not in Commercial Distribution

  • DIVO5745201 ()
  • DIVO5745200 ()
  • DIVO5745202 ()
574520

  • Dental appliance fabrication material, ceramic
CUSTOM PACK CB5W39R26 1/4 RD E
MEDTRONIC, INC.
CB5W39R26
In Commercial Distribution

  • 00643169713567 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB5V43R1 1/4 E B
MEDTRONIC, INC.
CB5V43R1
In Commercial Distribution

  • 00643169596344 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK 5G80R6 E. 1/4 PK
MEDTRONIC, INC.
5G80R6
Not in Commercial Distribution

  • 00643169578531 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB5P36R10 E 1/4 PK
MEDTRONIC, INC.
CB5P36R10
In Commercial Distribution

  • 00643169569553 ()


  • Cardiopulmonary bypass system blood tubing set
PERIOTOME POWER FLEX FPT-1 D/E DURABLE
Power Dental U.S.A. Inc.
1930-5
In Commercial Distribution

  • D943193050 ()
1930-5

  • Orthodontic pliers
  • Periotome, reusable
PERIOTOME POWER FLEX FPT-2 D/E DURABLE
Power Dental U.S.A. Inc.
1930-4
In Commercial Distribution

  • D943193040 ()
1930-4

  • Orthodontic pliers
  • Periotome, reusable
SCALERS ANTERIOR N128 S/E SINGLE END
Power Dental U.S.A. Inc.
1303
In Commercial Distribution

  • D94313030 ()
1303

  • Dental excavator, reusable
  • Manual dental scaler, reusable
POWER FLEX PERIOTOME CVD S/E DURABLE
Power Dental U.S.A. Inc.
1930-2
In Commercial Distribution

  • D943193020 ()
1930-2

  • Orthodontic pliers
  • Periotome, reusable
POWER FLEX PERIOTOME STR S/E DURABLE
Power Dental U.S.A. Inc.
1930-1
In Commercial Distribution

  • D943193010 ()
1930-1

  • Orthodontic pliers
  • Periotome, reusable
CUSTOM PACK TL4B24R4 3/8 E P
MEDTRONIC, INC.
TL4B24R4
In Commercial Distribution

  • 00643169349087 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK TL3T02R6 1/4 E P
MEDTRONIC, INC.
TL3T02R6
In Commercial Distribution

  • 00643169349070 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB7Y78R 3/8 E B
MEDTRONIC, INC.
CB7Y78R
In Commercial Distribution

  • 00643169366701 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB7V76R 1/4 E SPRT
MEDTRONIC, INC.
BB7V76R
In Commercial Distribution

  • 00643169505698 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB7V77R 3/8 E SPRT
MEDTRONIC, INC.
BB7V77R
Not in Commercial Distribution

  • 00643169505681 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB8F65R A 3/8 E
MEDTRONIC, INC.
BB8F65R
In Commercial Distribution

  • 00643169451391 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB6V93R8 A 3/8 E
MEDTRONIC, INC.
CB6V93R8
Not in Commercial Distribution

  • 00643169842984 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK 5G80R9 E. 1/4 PK
MEDTRONIC, INC.
5G80R9
Not in Commercial Distribution

  • 00643169838321 ()


  • Cardiopulmonary bypass system blood tubing set
PR119-E (Small Red Applier, 19cm E Etch)
VITALITEC INTERNATIONAL, INC.
PR119-E
In Commercial Distribution

  • 00850001784306 ()

  • Length: 19 Centimeter


  • Open-surgery ligation clip applier
PJ128-E (Applier Small Yellow, 28cm E Etch)
VITALITEC INTERNATIONAL, INC.
PJ128-E
In Commercial Distribution

  • 00850001784214 ()

  • Length: 28 Centimeter


  • Open-surgery ligation clip applier
PJ115-E (Small Clip Applier, 15cm (E- Model))
VITALITEC INTERNATIONAL, INC.
PJ115-E
In Commercial Distribution

  • 00850001784177 ()

  • Length: 15 Centimeter


  • Open-surgery ligation clip applier
PR115-E (Small Red Applier, 15cm E Etch)
VITALITEC INTERNATIONAL, INC.
PR115-E
In Commercial Distribution

  • 00850001784290 ()

  • Length: 15 Centimeter


  • Open-surgery ligation clip applier
PL528-E (Applier Small/Med 28cm E Etch)
VITALITEC INTERNATIONAL, INC.
PL528-E
In Commercial Distribution

  • 00850001784122 ()

  • Length: 28 Centimeter


  • Open-surgery ligation clip applier
PL515-E (Applier Small Lilac , 15cm E Etch)
VITALITEC INTERNATIONAL, INC.
PL515-E
In Commercial Distribution

  • 00850001784092 ()

  • Length: 15 Centimeter


  • Open-surgery ligation clip applier
HISTOCORE SPECTRA H&E STAINING SYSTEM S3
Leica Biosystems Richmond, Inc.
3801658
In Commercial Distribution

  • 00849832021247 ()

  • Device Size Text, specify:
3801658

  • Biological stain IVD
HistoCore SPECTRA H&E Staining System S1-800
Leica Biosystems Richmond, Inc.
3801656
In Commercial Distribution

  • 00849832020523 ()

  • Device Size Text, specify:
3801656

  • Biological stain IVD
HistoCore SPECTRA H&E Staining System S1
Leica Biosystems Richmond, Inc.
000000000003801654
In Commercial Distribution

  • 00849832013464 ()

  • Device Size Text, specify:


  • Biological stain IVD
FLEXCOIL 9733063 BAND D/E ADJUSTBLE 10PK
MEDTRONIC NAVIGATION, INC.
9733063
In Commercial Distribution

  • 00613994209658 ()
  • 70613994209657 ()


  • Extremity MRI system, permanent magnet
INSTRUMENT 7756157 SRWDRVR SLF HLG E HEX
MEDTRONIC SOFAMOR DANEK, INC.
7756157
In Commercial Distribution

  • 00613994207920 ()


  • Surgical screwdriver, reusable
TRAY 7068304 TRAY E - 4.75 GEN INSTRMTS
MEDTRONIC SOFAMOR DANEK, INC.
7068304
In Commercial Distribution

  • 00613994617705 ()


  • Instrument tray, reusable
e•Sense 7Fr Dual Sensor Urethral Catheter
Laborie Medical Technologies Corp.
CATEB37
In Commercial Distribution

  • 10627825013540 ()
  • 00627825013543 ()
  • 20627825013547 ()


  • Urodynamic manometric catheter, electronic, single-use
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