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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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BAHADIR USA - 00859982006216

METAL ID LABEL, CUSTOM ENGRAVE, GREEN
BAHADIR USA LLC
Y820.05
In Commercial Distribution

  • 00859982006216 ()
971004

  • Device sterilization/disinfection container, reusable

BAHADIR USA - 00859982006209

METAL ID LABEL, CUSTOM ENGRAVE, BLUE
BAHADIR USA LLC
Y820.04
In Commercial Distribution

  • 00859982006209 ()
971003

  • Device sterilization/disinfection container, reusable

BAHADIR USA - 00859982006193

METAL ID LABEL, CUSTOM ENGRAVE, RED
BAHADIR USA LLC
Y820.03
In Commercial Distribution

  • 00859982006193 ()
971002

  • Device sterilization/disinfection container, reusable

BAHADIR USA - 00859982006186

METAL ID LABEL, CUSTOM ENGRAVE, YELLOW
BAHADIR USA LLC
Y820.02
In Commercial Distribution

  • 00859982006186 ()
971001

  • Device sterilization/disinfection container, reusable

BAHADIR USA - 00859982006179

METAL ID LABEL, CUSTOM ENGRAVE, SILVER
BAHADIR USA LLC
Y820.01
In Commercial Distribution

  • 00859982006179 ()
971000

  • Device sterilization/disinfection container, reusable

Mui Scientific - 00678467001450

Barostat Tubing (OD=4.8mm, ID=3.3mm)
H & A Mui Enterprises Inc
CM54807
Not in Commercial Distribution

  • 00678467001450 ()


  • Gastrointestinal motility manometric catheter, non-electronic

Boosting Catheter - 00853892004058

Support Catheter, .052" ID x 150cm
QXMEDICAL
BC52-150
In Commercial Distribution

  • 00853892004058 ()

  • Lumen/Inner Diameter: 0.052 Inch
  • Length: 150 Centimeter
BC52-150

  • Vascular guide-catheter, single-use

Boosting Catheter - 00853892004041

Support Catheter, .072" ID x 150cm
QXMEDICAL
BC72-150
In Commercial Distribution

  • 00853892004041 ()

  • Lumen/Inner Diameter: 0.072 Inch
  • Length: 150 Centimeter
BC72-150

  • Vascular guide-catheter, single-use

Boosting Catheter - 00853892004034

Support Catheter, .063" ID x 150cm
QXMEDICAL
BC63-150
In Commercial Distribution

  • 00853892004034 ()

  • Lumen/Inner Diameter: 0.063 Inch
  • Length: 150 Centimeter
BC63-150

  • Vascular guide-catheter, single-use

Boosting Catheter - 00853892004027

Support Catheter, .057" ID x 150cm
QXMEDICAL
BC57-150
In Commercial Distribution

  • 00853892004027 ()

  • Lumen/Inner Diameter: 0.057 Inch
  • Length: 150 Centimeter
BC57-150

  • Vascular guide-catheter, single-use

Midas Rex MR8 - 00643169844582

TOOL MR8-9HS135 9CM HOLESAW 13.5MM ID
MEDTRONIC POWERED SURGICAL SOLUTIONS
MR8-9HS135
In Commercial Distribution

  • 00643169844582 ()


  • Orthopaedic bur, single-use

PMT CORPORATION - 00650551002734

CRW 2.4mm ID - 135mm Long Bushing
PMT CORPORATION
2103-224
In Commercial Distribution

  • 00650551002734 ()


  • Neurological stereotactic surgery system

Adaptor - 00709078011528

Adaptor 22mm ID x 19mm OD
WESTMED, INC.
7-5117
In Commercial Distribution

  • 00709078011528 ()
  • 10709078011563 ()


  • Straight/elbow breathing circuit connector, single-use

OnScope(TM) Endoscopic Dilator Kit - 06932503525237

Dilator Kit(OD=18mm, ID=9.2mm)
Micro-Tech (Nanjing) Co., Ltd.
DILA03002
In Commercial Distribution

  • 16932503525234 ()
  • 06932503525237 ()
  • 26932503525231 ()

  • Outer Diameter: 18 Millimeter


  • Endoscopic gastrointestinal stenosis dilator

OnScope(TM) Endoscopic Dilator Kit - 06932503525220

Dilator Kit(OD=19mm, ID=9.2mm)
Micro-Tech (Nanjing) Co., Ltd.
DILA02002
In Commercial Distribution

  • 16932503525227 ()
  • 06932503525220 ()
  • 26932503525224 ()

  • Outer Diameter: 19 Millimeter


  • Endoscopic gastrointestinal stenosis dilator

OptiMesh Multiplanar Expandable Interbody Fusion System - M7401001283

Globus Collet 4mm ID, 14.9mm OD
SPINEOLOGY INC.
102-45-01
In Commercial Distribution

  • M7401001283 ()

  • Lumen/Inner Diameter: 4 Millimeter
  • Outer Diameter: 14.9 Millimeter
100-1283

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CEKA & PRECI-LINE ATTACHMENTS - 04260576943736

PARALLELING MANDREL CEKA ID 1 P.
Alphadent NV
P 9
In Commercial Distribution

  • 04260576943736 ()
P 9

  • Dental mandrel

Bencox Hip System - 08800017282558

Bencox ID stem Rasp No.2.5
Corentec Co., Ltd
01.55.102
In Commercial Distribution

  • 08800017282558 ()


  • Bone file/rasp, manual, reusable
  • Femoral stem prosthesis trial

Pinch™ - 10810038093359

Metal Matrix, Premolar, No ID Hole
GARRISON DENTAL SOLUTIONS, L.L.C.
KMM100
In Commercial Distribution

  • 00810038093352 ()
  • 10810038093359 ()
KMM100

  • Dental matrix band, single-use

Marina Medical - 00840306824081

Hirschmann Anoscope, Small, 5.5cm, 1.6cm ID
MARINA MEDICAL INSTRUMENTS, INC.
210-001
In Commercial Distribution

  • 00840306824081 ()

  • Length: 1.6 Centimeter
210-001

  • Optical anoscope, reusable

SpiritMB - 00889989007473

ID P - Twin - Upper-Universal Bicuspid-Hook - Orange
ORMCO CORPORATION
495-1514
Not in Commercial Distribution

  • 00889989007473 ()
  • 10889989007470 ()

  • Slot: .022, Torque: -7


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007466

ID U - Twin - Lower-Left Cuspid-Hook - Purple
ORMCO CORPORATION
495-1411
Not in Commercial Distribution

  • 00889989007466 ()
  • 10889989007463 ()

  • Slot: .022, Torque: -7


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007459

ID U - Twin - Lower-Right Cuspid-Hook - Purple
ORMCO CORPORATION
495-1410
Not in Commercial Distribution

  • 00889989007459 ()
  • 10889989007456 ()

  • Slot: .022, Torque: -7


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007442

ID K - Twin - Upper-Left Cuspid-Hook - Green
ORMCO CORPORATION
495-1301
Not in Commercial Distribution

  • 00889989007442 ()
  • 10889989007449 ()

  • Slot: .022, Torque: 0


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007435

ID K - Twin - Upper-Right Cuspid-Hook - Green
ORMCO CORPORATION
495-1300
Not in Commercial Distribution

  • 00889989007435 ()
  • 10889989007432 ()

  • Slot: .022, Torque: 0


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007404

ID P - Twin - Upper-Universal Bicuspid - Orange
ORMCO CORPORATION
495-0514
Not in Commercial Distribution

  • 00889989007404 ()
  • 10889989007401 ()

  • Slot: .022, Torque: -7


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007398

ID U - Twin - Lower-Left Cuspid - Purple
ORMCO CORPORATION
495-0411
Not in Commercial Distribution

  • 00889989007398 ()
  • 10889989007395 ()

  • Slot: .022, Torque: -7


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007381

ID U - Twin - Lower-Right Cuspid - Purple
ORMCO CORPORATION
495-0410
Not in Commercial Distribution

  • 00889989007381 ()
  • 10889989007388 ()

  • Slot: .022, Torque: -7


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007374

ID K - Twin - Upper-Left Cuspid - Green
ORMCO CORPORATION
495-0301
Not in Commercial Distribution

  • 00889989007374 ()
  • 10889989007371 ()

  • Slot: .022, Torque: 0


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007367

ID K - Twin - Upper-Right Cuspid - Green
ORMCO CORPORATION
495-0300
Not in Commercial Distribution

  • 00889989007367 ()
  • 10889989007364 ()

  • Slot: .022, Torque: 0


  • Orthodontic bracket, plastic, single-use
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