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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SCREW, STERNAL, MAXDRIVE, LOCKING, DRILL FREE, TI-6AL-4V
KLS-Martin L.P.
24-023-09-09
In Commercial Distribution

  • 10888118031591 ()
  • 00888118031594 ()

  • 2.3 X 9 MM


  • Orthopaedic fixation plate, non-bioabsorbable
SCREW, STERNAL, MAXDRIVE, LOCKING, DRILL FREE, TI-6AL-4V
KLS-Martin L.P.
24-023-07-09
In Commercial Distribution

  • 10888118031577 ()
  • 00888118031570 ()

  • 2.3 X 7 MM


  • Orthopaedic fixation plate, non-bioabsorbable
100strips/ 1 bottle
DFI CO.,LTD
8174
Not in Commercial Distribution

  • 08806141302643 ()


  • Urine pH IVD, kit, rapid colorimetric, clinical
One device is included 100 test strips
DFI CO.,LTD
30D4
Not in Commercial Distribution

  • 08806141303497 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
The one device included 100 Strips
DFI CO.,LTD
3374
Not in Commercial Distribution

  • 08806141303480 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
100strip / 1 bottle
DFI CO.,LTD
81A4
Not in Commercial Distribution

  • 08806141302650 ()


  • Urine ketone IVD, kit, rapid colorimetric, clinical
100strip/1 bottle
DFI CO.,LTD
8194
Not in Commercial Distribution

  • 08806141302025 ()


  • Urine protein IVD, kit, rapid colorimetric, clinical
No Description
Osstem Implant Co., Ltd.
HODK
In Commercial Distribution

  • 08800000941431 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Articulated arm
Jeisys Medical Inc.
Edge ONE Arm
In Commercial Distribution

  • 08800020110022 ()


  • Dermatological carbon dioxide laser system
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190011857 ()
PP1-0002

  • Dental implant system
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
C
In Commercial Distribution

  • 10810190019280 ()
PP1-0002

  • Dental implant system
Endodontic instrument for professionnal dental use only
MICRO MEGA
N35 4% L31 STERILE
In Commercial Distribution

  • J015600298919 ()
  • J015600298911 ()
  • J015600298910 ()
60029891

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
N25 4% L31 STERILE
In Commercial Distribution

  • J015600298899 ()
  • J015600298891 ()
  • J015600298890 ()
60029889

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
N45 4% L25 STERILE
In Commercial Distribution

  • J015600298879 ()
  • J015600298871 ()
  • J015600298870 ()
60029887

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
N35 4% L25 STERILE
In Commercial Distribution

  • J015600298869 ()
  • J015600298861 ()
  • J015600298860 ()
60029886

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
N25 6% L25 STERILE
In Commercial Distribution

  • J015600298859 ()
  • J015600298851 ()
  • J015600298850 ()
60029885

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
N25 4% L25 STERILE
In Commercial Distribution

  • J015600298849 ()
  • J015600298841 ()
  • J015600298840 ()
60029884

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
N20 4% L25 STERILE
In Commercial Distribution

  • J015600298839 ()
  • J015600298831 ()
  • J015600298830 ()
60029883

  • Rotary/reciprocating endodontic file/rasp, single-use
No Description
Coltène/Whaledent AG
7054
In Commercial Distribution

  • J00670540 ()
7054

  • Dentine bonding agent/set
No Description
Coltène/Whaledent AG
7049
Not in Commercial Distribution

  • J00670490 ()
7049

  • Dentine bonding agent/set
No Description
Coltène/Whaledent AG
7047
Not in Commercial Distribution

  • J00670470 ()
7047

  • Dentine bonding agent/set
No Description
Coltène/Whaledent AG
7879
In Commercial Distribution

  • J00678790 ()
7879

  • Dentine bonding agent/set
No Description
Coltène/Whaledent AG
7873
In Commercial Distribution

  • J00678730 ()
7873

  • Dentine bonding agent/set
Endodontic instrument for professionnal dental use only
MICRO MEGA
N45 4% L21 STERILE
In Commercial Distribution

  • J015600298829 ()
  • J015600298821 ()
  • J015600298820 ()
60029882

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
N35 4% L21 STERILE
In Commercial Distribution

  • J015600298819 ()
  • J015600298811 ()
  • J015600298810 ()
60029881

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
N25 6% L21 STERILE
In Commercial Distribution

  • J015600298809 ()
  • J015600298801 ()
  • J015600298800 ()
60029880

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
N25 4% L21 STERILE
In Commercial Distribution

  • J015600298799 ()
  • J015600298791 ()
  • J015600298790 ()
60029879

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
N20 4% L21 STERILE
In Commercial Distribution

  • J015600298789 ()
  • J015600298781 ()
  • J015600298780 ()
60029878

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n037 6% L29
In Commercial Distribution

  • J015209492139 ()
  • J015209492131 ()
  • J015209492130 ()
20949213

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n037 6% L25
In Commercial Distribution

  • J015209492129 ()
  • J015209492121 ()
  • J015209492120 ()
20949212

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal use only
MICRO MEGA
n037 6% L21
In Commercial Distribution

  • J015209492119 ()
  • J015209492111 ()
  • J015209492110 ()
20949211

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n030 6% L25
In Commercial Distribution

  • J015209492029 ()
  • J015209492021 ()
  • J015209492020 ()
20949202

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
ONE SHAPE APICAL1 n030 6% L21 Classics sterile
In Commercial Distribution

  • J015209492011 ()
  • J015209492012 ()
  • J015209492010 ()
20949201

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
L25 Assorted Sterile
In Commercial Distribution

  • J015600298999 ()
  • J015600298991 ()
  • J015600298990 ()
60029899

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
L21 Assorted Sterile
In Commercial Distribution

  • J015600298989 ()
  • J015600298981 ()
  • J015600298980 ()
60029898

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
N45 4% L31 STERILE
In Commercial Distribution

  • J015600298929 ()
  • J015600298920 ()
  • J015600298921 ()
60029892

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
N25 6% L31 STERILE
In Commercial Distribution

  • J015600298909 ()
  • J015600298901 ()
  • J015600298900 ()
60029890

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
N20 4% L31 STERILE
In Commercial Distribution

  • J015600298889 ()
  • J015600298881 ()
  • J015600298880 ()
60029888

  • Rotary/reciprocating endodontic file/rasp, single-use
ONE SERIES ULTRA CARTRIDGE 30/BOX
JOHNSON & JOHNSON SURGICAL VISION, INC.
1VIPR30
In Commercial Distribution

  • 15050474534602 ()
  • 05050474534605 ()
1VIPR30

  • Intraocular lens-insertion cartridge
No Description
Coltène/Whaledent AG
60011757
In Commercial Distribution

  • J006600117570 ()
60011757

  • Dentine bonding agent/set
Endodontic instrument for professionnal dental use only
MICRO MEGA
L31 Assorted Sterile
In Commercial Distribution

  • J015600299009 ()
  • J015600299001 ()
  • J015600299000 ()
60029900

  • Rotary/reciprocating endodontic file/rasp, single-use
System One Heated Tube Humidifier, China
Respironics, Inc.
System One Heated Tube Humidifier, CN
Not in Commercial Distribution

  • 00606959049833 ()
CNSYS1HT15

  • Heated respiratory humidifier
System One Heated Tube Humidifier, Italy
Respironics, Inc.
System One Heated Tube Humidifier, IT
In Commercial Distribution

  • 00606959048249 ()
IT6T

  • Heated respiratory humidifier
ANNE One is a wireless vital signs and physiological data monitoring platform that streams real-time biosignals including electrocardiography, acceleration, and temperature to measure vital signs such as heart rate, respiratory rate, body temperature, skin temperature, step count, and fall count. The system features two skin-mounted, bio-integrated sensors that pair with an associated proprietary software application for the display of real-time vital sign measurements.
Sibel Health Inc.
SA-002
In Commercial Distribution

  • 00860004541707 ()


  • Wearable multiple physiological parameter recorder, reusable
Ranfac Injection Needle, F/G, Sterile P/N 74343-01M
RANFAC CORP.
11 Gauge x 11cm
In Commercial Distribution

  • 00857878007842 ()
  • 10857878007849 ()

  • Needle Gauge: 11 Gauge
  • Length: 11 Centimeter
RIN-11-11

  • Bone access cannula
No Description
1BYONEPRODUCTS INC.
703NA-0005
In Commercial Distribution

  • 00858069007221 ()
  • 00858069007207 ()
  • 10858069007228 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
No Description
1BYONEPRODUCTS INC.
9-JK14US05
In Commercial Distribution

  • 00858069007191 ()
  • 00858069007184 ()
  • 10858069007198 ()


  • Telemetric sphygmomanometer
No Description
1BYONEPRODUCTS INC.
9-JK14US06
In Commercial Distribution

  • 00858069007177 ()
  • 00858069007153 ()
  • 10858069007174 ()


  • Telemetric sphygmomanometer
No Description
Silhouet-Tone Corporation
412130
In Commercial Distribution

  • 00667259000191 ()


  • General examination/treatment chair, electric
For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in serum or urine.
GERMAINE LABORATORIES, INC
97734
In Commercial Distribution

  • 00695684977344 ()
  • 00695684977301 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
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