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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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This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to the patient.
LASER ENGINEERING
HWG505
In Commercial Distribution

  • 10866988000213 ()
  • 00866988000216 ()
HWG505

  • Urogenital surgical laser system beam guide, single-use
The Galea Elevator is a stainless-steel, reusable, manual surgical instrument designed to retract and elevate scalp tissue.
ARKIS BIOSCIENCES INC.
41.312.101
Not in Commercial Distribution

  • 00866614000115 ()
41.312.101

  • Hand-held surgical retractor, reusable
NON INVASIVE BLOOD PRESSURE NYLON CUFF SMALL CHILD DOUBLE TUBE
KENTRON HEALTHCARE, INC.
177808D
In Commercial Distribution

  • 00866512000286 ()
177808D

  • Blood pressure cuff, reusable
NON INVASIVE BLOOD PRESSURE NYLON CUFF NEW BORN DOUBLE TUBE
KENTRON HEALTHCARE, INC.
177806D
In Commercial Distribution

  • 00866512000262 ()
177806D

  • Blood pressure cuff, reusable
Cystosure Scope, 30 deg, 2.7 mm OD, 270 mm long
EMMY MEDICAL LLC
10-330
In Commercial Distribution

  • 00866403000265 ()

  • Outer Diameter: 2.7 Millimeter
  • Shaft Length: 270 Millimeter


  • Rigid optical cystoscope
16Fr Cystosure Plus, 16Fr, silicone catheter
EMMY MEDICAL LLC
10-400
In Commercial Distribution

  • 00866403000210 ()
  • 10866403000217 ()
  • 20866403000214 ()

  • Catheter Gauge: 16 French


  • Indwelling urethral drainage balloon catheter, non-antimicrobial
Cystosure XL, 16 Fr, silicone catheter
EMMY MEDICAL LLC
10-600
In Commercial Distribution

  • 00866403000203 ()
  • 10866403000200 ()
  • 20866403000207 ()

  • Catheter Gauge: 16 French


  • Indwelling urethral drainage balloon catheter, non-antimicrobial
The Tube Stripper is a “plier-like” tool used to strip/expel undiluted residual blood, in the PVC tubing segment, back into the blood component bag. The Tube Stripper operates on the principle of using two rolling wheels to squeeze fluid forward. The operator manually places the PVC tubing segment between the two roller wheels, grips the clamp body, and slides the Tube Stripper forward along the PVC tubing segment. As the segment is compressed between the two roller wheels, the residual blood within the PVC tubing segment flows forward until it completely drains into the blood component bag. When used in blood/blood component processing applications, the Tube Stripper facilitates manual mixing with anticoagulant and red cells. The Tube Stripper has no intended medical purpose and is not intended for in vitro use in blood banking.
GENESIS BPS LLC
HS-002
In Commercial Distribution

  • 00866305000288 ()
4A-HS-002

  • Blood tube stripper
The Genesis RapidWeld II STW, model GRW-430-02, 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-430-02
In Commercial Distribution

  • 00866305000264 ()

  • Length: 33 Centimeter
  • Height: 9.9 Centimeter
  • Width: 14.2 Centimeter
  • Weight: 2.5 Kilogram
480-RW-2607-02

  • Laboratory tubing welder
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
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