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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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The TCD B40 is a bench top, portable device intended for use by appropriately trained and qualified personnel in hospital/laboratory/clinical settings for the purpose of making sterile connections of 3.9 mm to 4.5 mm PVC tubing in blood processing applications.
GENESIS BPS LLC
TCD B40
In Commercial Distribution

  • 00866305000219 ()

  • Weight: 1.6 Kilogram
  • Width: 9.1 Centimeter
  • Length: 27.2 Centimeter
  • Height: 5.9 Centimeter
480-B40-00-1245

  • Laboratory tubing welder
No Description
INTERSCOPE, INC
ER 10-03-OP-S
Not in Commercial Distribution

  • 00865830000299 ()
ER 10-03-OP-S

  • Tissue morcellation system handpiece, line-powered
No Description
INTERSCOPE, INC
ER 10-02
Not in Commercial Distribution

  • 00865830000268 ()
ER 10-02

  • Tissue morcellation system handpiece, line-powered
No Description
INTERSCOPE, INC
ERC 20-01
In Commercial Distribution

  • 00865830000220 ()
ERC 20-01

  • Tissue morcellation system control unit
No Description
INTERSCOPE, INC
ER 10-01
Not in Commercial Distribution

  • 00865830000213 ()
ER 10-01

  • Tissue morcellation system handpiece, line-powered
This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to the patient.
LASER ENGINEERING
HWG305-OTO
In Commercial Distribution

  • 10866988000299 ()
  • 00866988000292 ()
HWG305-OTO

  • Urogenital surgical laser system beam guide, single-use
This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to the patient.
LASER ENGINEERING
HWG300-OTO
In Commercial Distribution

  • 10866988000268 ()
  • 00866988000261 ()
HWG300-OTO

  • Urogenital surgical laser system beam guide, single-use
CO2 Laser Waveguide - 500 microns
LASER ENGINEERING
CO2-500
In Commercial Distribution

  • 10866988000237 ()
  • 00866988000230 ()
CO2-500

  • Urogenital surgical laser system beam guide, single-use
This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to the patient
LASER ENGINEERING
HWG500-2.0-3.0
In Commercial Distribution

  • 00866988000209 ()
  • 10866988000206 ()
HWG500-2.0-3.0

  • Urogenital surgical laser system beam guide, single-use
NON INVASIVE BLOOD PRESSURE NYLON CUFF CHILD DOUBLE TUBE
KENTRON HEALTHCARE, INC.
177809D
In Commercial Distribution

  • 00866512000293 ()
177809D

  • Blood pressure cuff, reusable
NON INVASIVE BLOOD PRESSURE NYLON CUFF INFANT DOUBLE TUBE
KENTRON HEALTHCARE, INC.
177807D
In Commercial Distribution

  • 00866512000279 ()
177807D

  • Blood pressure cuff, reusable
NON INVASIVE BLOOD PRESSURE NYLON CUFF NEONATE #5 DOUBLE TUBE
KENTRON HEALTHCARE, INC.
177805D
In Commercial Distribution

  • 00866512000255 ()
177805D

  • Blood pressure cuff, reusable
Scope, 70 deg, 2.7 mm, long (270mm)
EMMY MEDICAL LLC
10-300
In Commercial Distribution

  • 00866403000234 ()

  • Outer Diameter: 2.7 Millimeter


  • Rigid optical cystoscope
The Genesis Rapid Weld STW is a medical device used in laboratories, designed for the purpose of making sterile connections in PVC tubing in blood processing applications. The device enables fluid transfer while maintaining a closed system without the need for a consumable (disposable wafer).
GENESIS BPS LLC
GRW-430
In Commercial Distribution

  • 00866305000202 ()

  • Weight: 2.5 Kilogram
  • Width: 14.2 Centimeter
  • Height: 9.9 Centimeter
  • Length: 33 Centimeter
480-RW-2607-00

  • Laboratory tubing welder
No Description
INTERSCOPE, INC
ER 10-03-F
Not in Commercial Distribution

  • 00865830000282 ()
ER 10-03-F

  • Tissue morcellation system handpiece, line-powered
No Description
INTERSCOPE, INC
ER 10-03
Not in Commercial Distribution

  • 00865830000206 ()
ER 10-03

  • Tissue morcellation system handpiece, line-powered
12 Inst, Red/Black, RDDR, 2NH, 4C
HU-FRIEDY MFG. CO., LLC
IM41207RNC
In Commercial Distribution

  • 10889950051389 ()
IM41207RNC

  • Device sterilization/disinfection container, reusable
12 Inst, Red/Black, RDDR
HU-FRIEDY MFG. CO., LLC
IM41207RD
In Commercial Distribution

  • 10889950051372 ()
IM41207RD

  • Device sterilization/disinfection container, reusable
Spec Sig Series, Black Ultrasonic Insert
HU-FRIEDY MFG. CO., LLC
IM30HU7
In Commercial Distribution

  • 10889950050962 ()
IM30HU7

  • Device sterilization/disinfection container, reusable
22-inst Hinged, Black, NH, C6
HU-FRIEDY MFG. CO., LLC
I98H7NHC6
In Commercial Distribution

  • 10889950050245 ()
I98H7NHC6

  • Device sterilization/disinfection container, reusable
22-inst Hinged, Black, NH, AW, C6
HU-FRIEDY MFG. CO., LLC
I98H7NAC6
In Commercial Distribution

  • 10889950050238 ()
I98H7NAC6

  • Device sterilization/disinfection container, reusable
22-INST, BLACK, all LP,C8,3AW
HU-FRIEDY MFG. CO., LLC
I17LPC8A3
In Commercial Distribution

  • 10889950049799 ()
I17LPC8A3

  • Device sterilization/disinfection container, reusable
9x11.5 Cas, Red/Black NH
HU-FRIEDY MFG. CO., LLC
I107NH
In Commercial Distribution

  • 10889950049591 ()
I107NH

  • Device sterilization/disinfection container, reusable
#9 Black's SE Gold Knife
HU-FRIEDY MFG. CO., LLC
GK9
In Commercial Distribution

  • 10889950049461 ()
GK9

  • Periodontal knife
36GF Knife/Ligature Dir Satin Steel Hd
HU-FRIEDY MFG. CO., LLC
GK5480
Not in Commercial Distribution

  • 10889950049454 ()
GK5480

  • Periodontal knife
#36 GOLD FOIL KNIFE/H5 SCALER
HU-FRIEDY MFG. CO., LLC
GK5013
In Commercial Distribution

  • 10889950049447 ()
GK5013

  • Periodontal knife
PEDO 34 SE GOLD KNIFE, U OF PITTS
HU-FRIEDY MFG. CO., LLC
GK4254
Not in Commercial Distribution

  • 10889950049430 ()
GK4254

  • Periodontal knife
#28 SE Gold Foil Knife
HU-FRIEDY MFG. CO., LLC
GK28
Not in Commercial Distribution

  • 10889950049423 ()
GK28

  • Periodontal knife
GK7/GF36
HU-FRIEDY MFG. CO., LLC
GF5479
Not in Commercial Distribution

  • 10889950049416 ()
GF5479

  • Periodontal knife
GK7 Black's SE Gold Knife W/ #6 HDL SE
HU-FRIEDY MFG. CO., LLC
GF5458
In Commercial Distribution

  • 10889950049409 ()
GF5458

  • Periodontal knife
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