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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LL 1st BI W/HK W JIGS 4 mm Torque -17, Tip 0 0.46 mm (0.018")
TP ORTHODONTICS INC
294-642
In Commercial Distribution

  • 00192029023686 ()


  • Orthodontic bracket, metal
LR CUS W/DISTAL HK W JIGS 4 mm Torque -11, Tip +5 0.56 mm (0.022")
TP ORTHODONTICS INC
294-637
In Commercial Distribution

  • 00192029023679 ()


  • Orthodontic bracket, metal
LR CUS W/DISTAL HK W JIGS 4 mm Torque -11, Tip +5 0.46 mm (0.018")
TP ORTHODONTICS INC
294-635
In Commercial Distribution

  • 00192029023655 ()


  • Orthodontic bracket, metal
LR LAT W JIGS 3.5 mm Torque -1, Tip +2 0.56 mm (0.022")
TP ORTHODONTICS INC
294-597
In Commercial Distribution

  • 00192029023631 ()


  • Orthodontic bracket, metal
LR LAT W JIGS 3.5 mm Torque -1, Tip +2 0.46 mm (0.018")
TP ORTHODONTICS INC
294-595
In Commercial Distribution

  • 00192029023617 ()


  • Orthodontic bracket, metal
LR CEN W JIGS 3.5 mm Torque -1, Tip +2 0.56 mm (0.022")
TP ORTHODONTICS INC
294-589
In Commercial Distribution

  • 00192029023594 ()


  • Orthodontic bracket, metal
LR CEN W JIGS 3.5 mm Torque -1, Tip +2 0.46 mm (0.018")
TP ORTHODONTICS INC
294-587
In Commercial Distribution

  • 00192029023570 ()


  • Orthodontic bracket, metal
LR 2nd BI W/HK Torque -22, Tip 0 0.56 mm (0.022")
TP ORTHODONTICS INC
294-581
In Commercial Distribution

  • 00192029023556 ()


  • Orthodontic bracket, metal
LR 1st BI W/HK Torque -17, Tip 0 0.56 mm (0.022")
TP ORTHODONTICS INC
294-573
In Commercial Distribution

  • 00192029023532 ()


  • Orthodontic bracket, metal
LL 1st BI W/HK Torque -17, Tip 0 0.56 mm (0.022")
TP ORTHODONTICS INC
294-572
In Commercial Distribution

  • 00192029023525 ()


  • Orthodontic bracket, metal
LR CUS W/DISTAL HK Torque -11, Tip +5 0.56 mm (0.022")
TP ORTHODONTICS INC
294-565
In Commercial Distribution

  • 00192029023518 ()


  • Orthodontic bracket, metal
LL CUS W/DISTAL HK Torque -11, Tip +5 0.56 mm (0.022")
TP ORTHODONTICS INC
294-564
In Commercial Distribution

  • 00192029023501 ()


  • Orthodontic bracket, metal
LR ANT Torque -1, Tip +2 0.56 mm (0.022")
TP ORTHODONTICS INC
294-557
In Commercial Distribution

  • 00192029023495 ()


  • Orthodontic bracket, metal
LL ANT Torque -1, Tip +2 0.56 mm (0.022")
TP ORTHODONTICS INC
294-556
In Commercial Distribution

  • 00192029023488 ()


  • Orthodontic bracket, metal
UR CUS W/DISTAL HK W JIGS 4.5 mm Torque -2, Tip +11 0.56 mm (0.022")
TP ORTHODONTICS INC
294-177
In Commercial Distribution

  • 00192029023471 ()


  • Orthodontic bracket, metal
UL CUS W/DISTAL HK W JIGS 4.5 mm Torque -2, Tip +11 0.56 mm (0.022")
TP ORTHODONTICS INC
294-176
In Commercial Distribution

  • 00192029023464 ()


  • Orthodontic bracket, metal
UL CUS W/DISTAL HK W JIGS 4.5 mm Torque -2, Tip +11 0.46 mm (0.018")
TP ORTHODONTICS INC
294-174
In Commercial Distribution

  • 00192029023440 ()


  • Orthodontic bracket, metal
UL BI W/MESIAL HK W JIGS 4mm Torque -7, Tip 0 0.56 mm (0.022")
TP ORTHODONTICS INC
294-144
In Commercial Distribution

  • 00192029023426 ()


  • Orthodontic bracket, metal
UL BI W/MESIAL HK W JIGS 4 mm Torque -7, Tip 0 0.46 mm (0.018")
TP ORTHODONTICS INC
294-142
In Commercial Distribution

  • 00192029023402 ()


  • Orthodontic bracket, metal
UL CEN W JIGS 4 mm Torque +12, Tip +5 0.56 mm (0.022")
TP ORTHODONTICS INC
294-116
In Commercial Distribution

  • 00192029023389 ()


  • Orthodontic bracket, metal
UL CEN W JIGS 4 mm Torque +12, Tip +5 0.46 mm (0.018")
TP ORTHODONTICS INC
294-114
In Commercial Distribution

  • 00192029023365 ()


  • Orthodontic bracket, metal
UR LAT W JIGS 3.5 mm Torque +8, Tip +9 0.46 mm (0.018")
TP ORTHODONTICS INC
294-093
In Commercial Distribution

  • 00192029023310 ()


  • Orthodontic bracket, metal
UR LAT W JIGS 3.5 mm Torque +8, Tip +9 0.46 mm (0.018")
TP ORTHODONTICS INC
294-091
In Commercial Distribution

  • 00192029023297 ()


  • Orthodontic bracket, metal
UR BI W/MESIAL HK Torque -7, Tip 0 0.56 mm (0.022")
TP ORTHODONTICS INC
294-073
In Commercial Distribution

  • 00192029023273 ()


  • Orthodontic bracket, metal
UR CUS W/DISTAL HK Torque -2, Tip +11 0.56 mm (0.022")
TP ORTHODONTICS INC
294-065
In Commercial Distribution

  • 00192029023259 ()


  • Orthodontic bracket, metal
UR LAT Torque +8, Tip +9 0.56 mm (0.022")
TP ORTHODONTICS INC
294-057
In Commercial Distribution

  • 00192029023235 ()


  • Orthodontic bracket, metal
UL LAT Torque +8, Tip +9 0.56 mm (0.022")
TP ORTHODONTICS INC
294-056
In Commercial Distribution

  • 00192029023228 ()


  • Orthodontic bracket, metal
UR CEN Torque +12, Tip +5 0.56 mm (0.022")
TP ORTHODONTICS INC
294-053
In Commercial Distribution

  • 00192029023211 ()


  • Orthodontic bracket, metal
UL CEN Torque +12, Tip +5 0.56 mm (0.022")
TP ORTHODONTICS INC
294-052
In Commercial Distribution

  • 00192029023204 ()


  • Orthodontic bracket, metal
No Description
CNSystems Medizintechnik GmbH
V1.x.y
In Commercial Distribution

  • 09120073932440 ()


  • Multiparameter physiologic analysis workstation
No Description
MICROSURGICAL TECHNOLOGY, INC.
MK-0001
In Commercial Distribution

  • 00844685006090 ()
MK-0001

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
No Description
LIFE TECHNOLOGIES CORPORATION
35050061
Not in Commercial Distribution

  • 30190302004422 ()
  • 10190302004428 ()


  • Cell culture medium IVD
No Description
BIOCARE MEDICAL LLC
TRP955KH
In Commercial Distribution

  • 00847627012586 ()


  • Trypsin IVD, reagent
No Description
OXOID LIMITED
MB0181A
In Commercial Distribution

  • 05032384127818 ()


  • Multiple bacteria species culture isolate identification control IVD, kit
EpiLong
Pajunk GmbH Medizintechnologie
0431156-51
Not in Commercial Distribution

  • 14048223013110 ()
  • 04048223013113 ()
0431156-51

  • Epidural anaesthesia set, non-medicated
For differential staining in hematology that gives results similar to a Wright-Giemsa stain
Siemens Healthcare Diagnostics Products GmbH
10459380
Not in Commercial Distribution

  • 00630414976310 ()
B4132-11A

  • Differentiation solution IVD
A rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as guides for urethral injections, guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. Disposable imaging-supportive devices (e.g., ultrasound transducer cover/gel) may be included with the device. This is a single-use device.
FCI S A S FCI 20 22
S5.200.I
In Commercial Distribution

  • 23700773723908 ()
  • 13700773723901 ()


  • Needle guide, single-use
No Description
Biomet Orthopedics, LLC
32-348083
In Commercial Distribution

  • 00880304329652 ()
32-348083

  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Biomet Orthopedics, LLC
32-347121
In Commercial Distribution

  • 00880304327702 ()
32-347121

  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Biomet Orthopedics, LLC
424456
In Commercial Distribution

  • 00880304373662 ()
424456

  • Orthopaedic inorganic implant inserter/extractor, reusable
No Description
Biomet Orthopedics, LLC
32-467712
In Commercial Distribution

  • 00880304340169 ()
32-467712

  • Orthopaedic prosthesis implantation positioning instrument, reusable
The Sealing Connectors are a haemostatic valves used in minimally invasive procedures. The valves allow instruments to pass through while preventing blood or other fluids from leaking out. It is designed to maintain a seal around the inserted instruments.
WISMED PL SP Z O O
1
In Commercial Distribution

  • 05906168942242 ()


  • Haemostasis valve
No Description
Biomet Orthopedics, LLC
424780
In Commercial Distribution

  • 00880304374140 ()
424780

  • Orthopaedic inorganic implant inserter/extractor, reusable
Single channel dosimeter according to IEC 61674, designed for quality checks at radiographic, fluoroscopic, dental and mammographic X-ray units.
IBA Dosimetry GmbH
VD0201748
In Commercial Distribution

  • EIBAVD02017480 ()
VD0201748

  • Diagnostic x-ray system quality assurance device
No Description
implantcast GmbH
02821050
In Commercial Distribution

  • 04048844527563 ()


  • Orthopaedic implant impactor, reusable
Dental Implant Instrument KIT / i, s-Clean tapered KIT
DENTIS CO. ,LTD
DGIK
In Commercial Distribution

  • 08806169145383 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Dental Implant Instrument KIT / i, s-Clean tapered KIT
DENTIS CO. ,LTD
DIKO
In Commercial Distribution

  • 08806169145314 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Dental Implant Instrument KIT / i, s-Clean tapered KIT
DENTIS CO. ,LTD
DIK
In Commercial Distribution

  • 08806169135452 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Capture-R Ready-ID Extend I is intended for use in the detection and identification of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. The double-strip configuration is 2 x 8 strips containing test wells coated with D-positive red blood cell membranes of 14 group O single donors. This particular product code package configuration is made up of five (5) microplates of the identical product, and the identical lot number, placed into the one (1) single box.
IMMUCOR, INC.
0006455
In Commercial Distribution

  • 10888234000679 ()
0006455

  • Solid-phase red blood cell adherence antibody/antigen IVD
Capture-R Ready-ID Extend I is intended for use in the detection and identification of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. The double-strip configuration is composed of 2 x 8 strips which contain test wells coated with D-positive red cell membranes of 14 group O single donors.
IMMUCOR, INC.
0006454
In Commercial Distribution

  • 10888234000662 ()
0006454

  • Solid-phase red blood cell adherence antibody/antigen IVD
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