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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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CAPILLAROSCOPE WITH PROFESSIONAL SW (5X-200x)
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-317
Not in Commercial Distribution

  • B1623171 ()
FEDMEDMICFISTDSWC_US

  • Otoscope, direct
DEMATOSCOPE WITH PROFESSIONAL SW (10X-90x)
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-316
Not in Commercial Distribution

  • B1623161 ()
FEDMEDMICFIUVWPSWD_US

  • Otoscope, direct
DEMATOSCOPE WITH PROFESSIONAL SW (5X-200x)
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-314
Not in Commercial Distribution

  • B1623141 ()
FEDMEDMICFIPSWD_US

  • Otoscope, direct
BELLOW BLUE WITH VENTIL AND CONNECTION M8
SONTEC INSTRUMENTS, INC.
04-11020-10
Not in Commercial Distribution

  • B0990411020100 ()


  • ENT powder applicator
Tubing used to detect airflow in sleep studies.
Braebon Medical Corporation
8599
In Commercial Distribution

  • B14085990 ()
8599

  • Gas-sampling/monitoring respiratory tubing, single-use
Component of the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
Braebon Medical Corporation
0571.2
In Commercial Distribution

  • B140057120 ()
0571.2

  • Pneumograph
272 micrometer ScopeSafe™ Laser Fiber with SoftTip™
OPTICAL INTEGRITY INC
11613
In Commercial Distribution

  • B145116130 ()
  • B145116135 ()
  • B145116131 ()
  • B145116831 ()
  • B145116150 ()
  • B145116171 ()

  • Outer Diameter: 272 Micrometer
SU-200-ST

  • General/multiple surgical laser system beam guide, reusable
200 micrometer ScopeSafe™ Laser Fiber with SoftTip™
OPTICAL INTEGRITY INC
11607
In Commercial Distribution

  • B145116070 ()
  • B145116111 ()

  • Outer Diameter: 375 Micrometer
SU-200-TRUE-ST

  • General/multiple surgical laser system beam guide, reusable
No Description
Biomet Orthopedics, LLC
24345
In Commercial Distribution

  • 00888480233749 ()
24345

  • Surgical instrument handle, non-torque-limiting
The PLEGIOX cardioplegia heat exchanger is used for adjusting the temperature of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The PLEGIOX contains heat exchanger fibers through which the cooling or heating fluid is pumped. The fluid to be temperature controlled flows around the outside of these fibers. Deairing is ensured by a bubble trap with a filter integrated in the upper part of the PLEGIOX. An integrated bypass stopcock enables hot-shot to be performed.
Maquet Cardiopulmonary AG
CHX 30, Non-coated, Sterile
Not in Commercial Distribution

  • 04037691180038 ()
  • 04058863052267 ()

  • Total Volume: 46.885 Liter
  • Weight: 0.35 Kilogram
70103.2522

  • Cardiopulmonary bypass system heat exchanger, reusable
No Description
Otto Bock Healthcare Products GmbH
13E48=G800
Not in Commercial Distribution

  • 04032767084715 ()


  • Myoelectric hand prosthesis
No Description
Otto Bock Healthcare Products GmbH
13E48=G300
Not in Commercial Distribution

  • 04032767084692 ()


  • Myoelectric hand prosthesis
Aquatec R with blue cover-so
INVACARE CORPORATION
1574456
In Commercial Distribution

  • 04028698125542 ()
1574456

  • Basic toilet seat
Aquatec R with white cover-so
INVACARE CORPORATION
1574455
In Commercial Distribution

  • 04028698125535 ()
1574455

  • Basic toilet seat
Aquatec R with blue cover
INVACARE CORPORATION
1573972
In Commercial Distribution

  • 04028698125344 ()
1573972

  • Basic toilet seat
Aquatec R with white cover
INVACARE CORPORATION
1573878
In Commercial Distribution

  • 04028698125313 ()
1573878

  • Basic toilet seat
Aquatec R with white cover
INVACARE CORPORATION
1573877
In Commercial Distribution

  • 04028698125306 ()
1573877

  • Basic toilet seat
Aquatec XL with white cover
INVACARE CORPORATION
1573862
In Commercial Distribution

  • 04028698125238 ()
1573862

  • Basic toilet seat
Aquatec F with white cover
INVACARE CORPORATION
1573683
Not in Commercial Distribution

  • 04028698125177 ()
1573683

  • Basic toilet seat
No Description
Sarstedt Aktiengesellschaft & Co.KG
72.730
Not in Commercial Distribution

  • 04038917165990 ()
  • 04038917083782 ()
72.730

  • Assay container IVD, single-use
No Description
Sarstedt Aktiengesellschaft & Co.KG
72.694
In Commercial Distribution

  • 04038917165686 ()
  • 04038917083461 ()
72.694

  • Assay container IVD, single-use
No Description
Sarstedt Aktiengesellschaft & Co.KG
72.693
In Commercial Distribution

  • 04038917165679 ()
  • 04038917083454 ()
72.693

  • Assay container IVD, single-use
No Description
Sarstedt Aktiengesellschaft & Co.KG
72.692
In Commercial Distribution

  • 04038917165662 ()
  • 04038917083447 ()
72.692

  • Assay container IVD, single-use
BB Container Tray 21.25x10x2.75
KOROS U.S.A., INC.
7320-95
In Commercial Distribution

  • 00840199502400 ()
  • 10840199502407 ()
7320-95

  • Self-retaining surgical retractor, reusable
CALLCORD,8FT,3701,WITH INTERLOCK
CURBELL MEDICAL PRODUCTS, INC.
CC96-979
In Commercial Distribution

  • 00840828127349 ()
5873

  • Fixed call button
No Description
Sarstedt Aktiengesellschaft & Co.KG
72.730.309
In Commercial Distribution

  • 04038917994507 ()
  • 04038917994484 ()


  • Assay container IVD, single-use
No Description
Sarstedt Aktiengesellschaft & Co.KG
72.730.307
In Commercial Distribution

  • 04038917994330 ()
  • 04038917994316 ()


  • Assay container IVD, single-use
No Description
Sarstedt Aktiengesellschaft & Co.KG
72.730.300
In Commercial Distribution

  • 04038917994040 ()
  • 04038917994026 ()


  • Assay container IVD, single-use
No Description
Sarstedt Aktiengesellschaft & Co.KG
72.703.207
In Commercial Distribution

  • 04038917431156 ()
  • 04038917431149 ()
72.703.207

  • Assay container IVD, single-use
No Description
Sarstedt Aktiengesellschaft & Co.KG
75.562.400
In Commercial Distribution

  • 04038917236812 ()
  • 04038917236805 ()
75.562.400

  • Non-evacuated urine specimen container IVD, no additive
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