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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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LIFENET ALERT 64-BIT
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873901861 ()
21340-000801

  • Emergency/ambulatory healthcare software
HeartStart Configure
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
HeartStart Configure
In Commercial Distribution

  • 00884838041547 ()
861487

  • Emergency/ambulatory healthcare software
SCALER, DOUBLE END, TRADE IN, OFFSET SICKLE MONTANA JACK, #6 RELYANT HANDLE
NORDENT MANUFACTURING INC
TSCNMJ
In Commercial Distribution

  • 00840018622968 ()


  • Manual dental scaler, reusable
SCALER, OFFSET SICKLE MONTANA JACK UNIVERSAL R138 THIN BLADE, #6 RELYANT HANDLE
NORDENT MANUFACTURING INC
VSCNMJF
In Commercial Distribution

  • 00840018621350 ()


  • Manual dental scaler, reusable
SCALER, DOUBLE END, OFFSET SICKLE MONTANA JACK DISTAL COASTAL, #6 RELYANT HANDLE
NORDENT MANUFACTURING INC
VSCNMJDC
In Commercial Distribution

  • 00840018621343 ()


  • Manual dental scaler, reusable
SCALER, DOUBLE END, OFFSET SICKLE MONTANA JACK, UNIVERSAL R138, #6 RELYANT HANDLE
NORDENT MANUFACTURING INC
VSCNMJ
In Commercial Distribution

  • 00840018621336 ()


  • Manual dental scaler, reusable
Set Includes: R067 Columbia 4L-4R R092 H5-L5 Mini R138 Montana Jack®
PDT, INC.
R905 PDT3SAVER™ 3
In Commercial Distribution

  • 00813677024824 ()
R905

  • Manual dental scaler, reusable
  • Periodontal curette
Set Includes: R064 Columbia 13-14 R092 H5-L5 Mini R138 Montana Jack®
PDT, INC.
R904 PDT3SAVER™ 2
In Commercial Distribution

  • 00813677024800 ()
R904

  • Manual dental scaler, reusable
  • Periodontal curette
Set Includes: R061 Barnhart 5-6 R092 H5-L5 Mini R138 Montana Jack®
PDT, INC.
R903 PDT3SAVER™ 1
In Commercial Distribution

  • 00813677024794 ()
R903

  • Manual dental scaler, reusable
  • Periodontal curette
H2H Substitution Filter and packaging information
NEPHROS, INC.
70-6828
Not in Commercial Distribution

  • 10896241002074 ()
  • 00896241002077 ()
  • 20896241002071 ()


  • Haemodialysis system dialysate pyrogen-filtration set
SCALER, DOUBLE END, OFFSET SICKLE MONTANA JACK UNIVERSAL R138, XDURA COLOR RINGS HANDLE
NORDENT MANUFACTURING INC
TCNSNMJ
In Commercial Distribution

  • 00840018625754 ()


  • Manual dental scaler, reusable
SCALER, DOUBLE END, OFFSET SICKLE MONTANA JACK UNIVERSAL R138, DURALITE COLOR RINGS HANDLE
NORDENT MANUFACTURING INC
CENSNMJ
In Commercial Distribution

  • 00840018625280 ()


  • Manual dental scaler, reusable
SCALER, DOUBLE END, OFFSET SICKLE MONTANA JACK UNIVERSAL R138, XDURA DURALITE ROUND HANDLE
NORDENT MANUFACTURING INC
TRNSNMJ
In Commercial Distribution

  • 00840018624764 ()


  • Manual dental scaler, reusable
SCALER, DOUBLE END, OFFSET SICKLE MONTANA JACK UNIVERSAL R138, DURALITE COLOR RINGS HANDLE
NORDENT MANUFACTURING INC
CESCNMJ
In Commercial Distribution

  • 00840018619296 ()


  • Manual dental scaler, reusable
SCALER, DOUBLE END, OFFSET SICKLE MONTANA JACK UNIVERSAL R138 XDURA DURALITE ROUND HANDLE
NORDENT MANUFACTURING INC
RENSNMJ
In Commercial Distribution

  • 00840018624061 ()


  • Manual dental scaler, reusable
No Description
W.H. Holden, Inc.
70-5164HTIN
In Commercial Distribution

  • D928705164HTIN0 ()


  • Periodontal curette
No Description
W.H. Holden, Inc.
70-5164HF
In Commercial Distribution

  • D928705164HF0 ()


  • Periodontal curette
No Description
W.H. Holden, Inc.
70-5164CH
In Commercial Distribution

  • D928705164CH0 ()


  • Periodontal curette
No Description
Roche Diagnostics GmbH
04939417190
In Commercial Distribution

  • 04015630999347 ()
04939417190

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
4642490190
Not in Commercial Distribution

  • 04015630997961 ()
4642490190

  • Vancomycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
4642503190
Not in Commercial Distribution

  • 04015630997930 ()
4642503190

  • Tobramycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
4642481190
Not in Commercial Distribution

  • 04015630997978 ()
4642481190

  • Vancomycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
7258062190
In Commercial Distribution

  • 04015630936885 ()
7258062190

  • Carbamazepine therapeutic drug monitoring IVD, kit, fluorescent immunoassay
No Description
Roche Diagnostics GmbH
6769942190
In Commercial Distribution

  • 04015630935031 ()
6769942190

  • Acetaminophen IVD, kit, spectrophotometry
No Description
Roche Diagnostics GmbH
08058644190
In Commercial Distribution

  • 07613336121511 ()
08058644190

  • Cannabinoid/cannabinoid metabolite IVD, reagent
No Description
Roche Diagnostics GmbH
08056919190
In Commercial Distribution

  • 07613336170502 ()
08056919190

  • Benzodiazepine group IVD, reagent
No Description
Roche Diagnostics GmbH
08771669190
Not in Commercial Distribution

  • 07613336166239 ()
08771669190

  • Cannabinoid/cannabinoid metabolite IVD, reagent
No Description
Roche Diagnostics GmbH
08058130190
In Commercial Distribution

  • 07613336121450 ()
08058130190

  • Phencyclidine (PCP) IVD, reagent
No Description
Roche Diagnostics GmbH
08058113190
In Commercial Distribution

  • 07613336121443 ()
08058113190

  • Morphine/morphine metabolite IVD, reagent
No Description
Roche Diagnostics GmbH
08058008190
In Commercial Distribution

  • 07613336121405 ()
08058008190

  • Methadone IVD, reagent
No Description
Roche Diagnostics GmbH
08056927190
In Commercial Distribution

  • 07613336121054 ()
08056927190

  • Benzodiazepine group IVD, reagent
No Description
Roche Diagnostics GmbH
08056889190
In Commercial Distribution

  • 07613336121030 ()
08056889190

  • Barbiturate IVD, reagent
No Description
Roche Diagnostics GmbH
08056781190
In Commercial Distribution

  • 07613336120996 ()
08056781190

  • Amphetamine/methamphetamine group IVD, reagent
Assort. discovery® pearl,McLaugh.18,15-45 / Brackets / For further information please visit our online-
DENTAURUM GmbH & Co.KG
718-702-85
In Commercial Distribution

  • J011728702850 ()


  • Orthodontic bracket, ceramic
No Description
REAL VIEW IMAGING LTD
HOLOSCOPE-i
In Commercial Distribution

  • 07290018862018 ()


  • Ultrasound imaging system workstation
  • CT system workstation
The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
NEPHROS, INC.
TQE0.005-20HP3E
In Commercial Distribution

  • 10868277000454 ()
  • 00868277000457 ()
  • 20868277000451 ()


  • Haemodialysis system dialysate pyrogen filter
The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
NEPHROS, INC.
TQE0.005-10HP3E
In Commercial Distribution

  • 10868277000447 ()
  • 00868277000440 ()
  • 20868277000444 ()


  • Haemodialysis system dialysate pyrogen filter
PLNG STATION 9734669R RWK S7
MEDTRONIC NAVIGATION, INC.
9734669R
In Commercial Distribution

  • 00613994792921 ()


  • Stereotactic surgery system workstation
PLNG STATION 9734048 STEALTHSTATION S7
MEDTRONIC NAVIGATION, INC.
9734048
In Commercial Distribution

  • 00613994532398 ()


  • Stereotactic surgery system workstation
The EF-02D filter is a sterile dialysis fluid filter that produces ultrapure dialysate as defined in ANSI/AAMI/ISO 23500. The filter(s) are used as part of Hemodialysis machine hydraulic section.
NIKKISO CO.,LTD.
EF-02D
In Commercial Distribution

  • 24987671030218 ()
  • 04987671030214 ()


  • Haemodialysis system dialysate pyrogen filter
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