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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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Bronchial Stent with Posts - 00815347021409

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
BSP-1040-S
In Commercial Distribution

  • 00815347021409 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Bronchial Stent with Posts - 00815347021393

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
BSP-1030-S
In Commercial Distribution

  • 00815347021393 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Bronchial Stent with Posts - 00815347021386

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
BSP-1020-S
In Commercial Distribution

  • 00815347021386 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Bronchial Stent with Rings - 00815347021379

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
BS-0319-S
In Commercial Distribution

  • 00815347021379 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Bronchial Stent with Rings - 00815347021362

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
BS-0313-S
In Commercial Distribution

  • 00815347021362 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Bronchial Stent with Rings - 00815347021355

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
BS-1019-S
In Commercial Distribution

  • 00815347021355 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Bronchial Stent with Rings - 00815347021348

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
BS-0819-S
In Commercial Distribution

  • 00815347021348 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Bronchial Stent with Rings - 00815347021331

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
BS-0619-S
In Commercial Distribution

  • 00815347021331 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Bronchial Stent with Rings - 00815347021324

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
BS-1013-S
In Commercial Distribution

  • 00815347021324 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Bronchial Stent with Rings - 00815347021317

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
BS-0813-S
In Commercial Distribution

  • 00815347021317 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Bronchial Stent with Rings - 00815347020853

Hood Tracheo-Bronchial Prosthesis
HOOD, E BENSON LABORATORIES INC
BS-0613-S
In Commercial Distribution

  • 00815347020853 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Sterilization basket with lid - G006DJ4371178

Basket for sterilization with lid and without silicone mat (External dimensions: 280 x 145 x 50 mm)
EFER ENDOSCOPY
DJ-4371
In Commercial Distribution

  • G006DJ4371178 ()


  • Rigid optical bronchoscope

Sterilzation basket with lid - G006DJ4046SPEC927

Basket with lid for sterilization of adult endoscopes (External dimensions: 640 x 150 x 77 mm)
EFER ENDOSCOPY
DJ-4046-SPEC
In Commercial Distribution

  • G006DJ4046SPEC927 ()


  • Rigid optical bronchoscope

Myotrode One With Gel - D79240602

Non-jelled TENS Electrodes for use with Myomonitor. Designed for patients with sideburns or a beard.
MYOTRONICS NOROMED, INC
4060
In Commercial Distribution

  • D79240602 ()


  • Transcutaneous electrical stimulation electrode, single-use

Fastener Sleeve with Handle - 00816950027819

Fastener Sleeve with Handle
Osteocentric Technologies, Inc.
2004-0001-01
In Commercial Distribution

  • 00816950027819 ()
2004-0001-01

  • General external orthopaedic fixation system implantation kit, reusable

Insemination Cannula with Syringe - 00888937001228

Closed End, Open Side, Extra Fine Cannula, 3.5 Fr OD
Coopersurgical, Inc.
MX732
In Commercial Distribution

  • 20888937001222 ()
  • 00888937001228 ()


  • Assisted reproduction transfer catheter/set

Insemination Cannula with Syringe - 00888937001211

Open End, Fine Cannula, 8 Fr OD
Coopersurgical, Inc.
MX730
In Commercial Distribution

  • 20888937001215 ()
  • 00888937001211 ()


  • Assisted reproduction transfer catheter/set

EarHug Adaptor with Tubes - 00817020020020

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M015451
In Commercial Distribution

  • 00817020020020 ()


  • Earphone, insert

ImmunoRetriever 20X with EDTA - B502BSB00330

ImmunoDNA Retriever EDTA is a concentrate used with heat-induced epitope or nucleic acid retrieval procedures for Immunohistochemistry (IHC), Immunocytochemistry (ICC), Immunofluorescence (IF) and in situ hybridization (ISH) of nucleic acids (both CISH or FISH).
BIO SB, INC.
50 ml
In Commercial Distribution

  • B502BSB00330 ()
BSB 0033

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

ImmunoRetriever 20X with EDTA - B502BSB00320

ImmunoDNA Retriever EDTA is a concentrate used with heat-induced epitope or nucleic acid retrieval procedures for Immunohistochemistry (IHC), Immunocytochemistry (ICC), Immunofluorescence (IF) and in situ hybridization (ISH) of nucleic acids (both CISH or FISH).
BIO SB, INC.
1000 ml
In Commercial Distribution

  • B502BSB00320 ()
BSB 0032

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

ImmunoRetriever 20X with EDTA - B502BSB00310

ImmunoDNA Retriever EDTA is a concentrate used with heat-induced epitope or nucleic acid retrieval procedures for Immunohistochemistry (IHC), Immunocytochemistry (ICC), Immunofluorescence (IF) and in situ hybridization (ISH) of nucleic acids (both CISH or FISH).
BIO SB, INC.
500 ml
In Commercial Distribution

  • B502BSB00310 ()
BSB 0031

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

ImmunoRetriever 20X with EDTA - B502BSB00300

ImmunoDNA Retriever EDTA is a concentrate used with heat-induced epitope or nucleic acid retrieval procedures for Immunohistochemistry (IHC), Immunocytochemistry (ICC), Immunofluorescence (IF) and in situ hybridization (ISH) of nucleic acids (both CISH or FISH).
BIO SB, INC.
200 ml
In Commercial Distribution

  • B502BSB00300 ()
BSB 0030

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

ImmunoRetriever 20X with Citrate - B502BSB00230

ImmunoDNA Retriever 20x Citrate is a concentrate intended to be used for pretreatment with heat-induced epitope or nucleic acid retrieval procedures for Immunohistochemistry (IHC), Immunocytochemistry (ICC), Immunofluorescence (IF) and in situ hybridization (ISH) of nucleic acids (CISH or FISH).
BIO SB, INC.
50 ml
In Commercial Distribution

  • B502BSB00230 ()
BSB 0023

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

ImmunoRetriever 20X with Citrate - B502BSB00220

ImmunoDNA Retriever 20x Citrate is a concentrate intended to be used for pretreatment with heat-induced epitope or nucleic acid retrieval procedures for Immunohistochemistry (IHC), Immunocytochemistry (ICC), Immunofluorescence (IF) and in situ hybridization (ISH) of nucleic acids (both CISH or FISH).
BIO SB, INC.
1000 ml
In Commercial Distribution

  • B502BSB00220 ()
BSB 0022

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

ImmunoRetriever 20X with Citrate - B502BSB00210

ImmunoDNA Retriever 20x Citrate is a concentrate intended to be used for pretreatment with heat-induced epitope or nucleic acid retrieval procedures for Immunohistochemistry (IHC), Immunocytochemistry (ICC), Immunofluorescence (IF) and in situ hybridization (ISH) of nucleic acids (both CISH or FISH)
BIO SB, INC.
500 ml
In Commercial Distribution

  • B502BSB00210 ()
BSB 0021

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

ImmunoRetriever 20X with Citrate - B502BSB00200

ImmunoDNA Retriever 20x Citrate is a concentrate intended to be used for pretreatment with heat-induced epitope or nucleic acid retrieval procedures for Immunohistochemistry (IHC), Immunocytochemistry (ICC), Immunofluorescence (IF) and in situ hybridization (ISH) of nucleic acids (both CISH or FISH)
BIO SB, INC.
200 ml
In Commercial Distribution

  • B502BSB00200 ()
BSB 0020

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Half Apron with Ties - G031804TRL0

Half Apron with Ties - 804T-10" x 10" -0.5mm Regular Lead (RL)
Shielding International Inc.
804TRL
In Commercial Distribution

  • G031804TRL0 ()


  • Radiation shielding apron

Half Apron with Ties - G031803TRL0

Half Apron with Ties - 803T-18" x 16" -0.5mm Regular Lead (RL)
Shielding International Inc.
803TRL
In Commercial Distribution

  • G031803TRL0 ()


  • Radiation shielding apron

Half Apron with Ties - G031802TRL0

Half Apron with Ties - 802T -24" x 20" -0.5mm Regular Lead (RL)
Shielding International Inc.
802TRL
In Commercial Distribution

  • G031802TRL0 ()


  • Radiation shielding apron

Half Apron with Ties - G031801TRL0

Half Apron with Ties - 801T -24"x24" -0.5mm Regular Lead (RL)
Shielding International Inc.
801TRL
In Commercial Distribution

  • G031801TRL0 ()


  • Radiation shielding apron

Round bar with rider - 07640166514831

Round bar with rider Transfer jig
Cendres+Métaux SA
072293
In Commercial Distribution

  • 07640166514831 ()
072293

  • Dental precision attachment simulator/analog, single-use

Round bar with rider - 07640166514213

Round bar with rider Female part E
Cendres+Métaux SA
055801
In Commercial Distribution

  • 07640239931602 ()
  • 07640166514213 ()
055801

  • Bar dental precision attachment

VORTRAN-IPPB with Water Trap - 10637320040217

The VORTRAN®-IPPB allows for single-patient use of an airway clearance device. It provides high aerosol output with a large nebulizer reservoir. It is easily set-up and more cost effective than a conventional IPPB machine. It is excellent for patients with fluid retention in the lungs.
VORTRAN MEDICAL TECHNOLOGY 1, INC
IPW-4021
In Commercial Distribution

  • 20637320040214 ()
  • 10637320040217 ()
IPW-4021

  • Ultrasonic nebulizing system

Bone hook with grip - 00889024302280

No Description
Zimmer GmbH
75.00.03
In Commercial Distribution

  • 00889024302280 ()
75.00.03

  • Joint prosthesis implantation kit, reusable

Rasp adapter with lever - 00889024301559

No Description
Zimmer GmbH
6835
In Commercial Distribution

  • 00889024301559 ()
6835

  • Femoral stem prosthesis trial

EBA WITH SOCKETS-21 WIRES - 00811478011722

No Description
ELECTRO-CAP INTERNATIONAL INC
E2S-21WIRE
In Commercial Distribution

  • 00811478011722 ()
E2S-21WIRE

  • Analytical scalp lead

STRETCHER WITH KNEE GATCH - B286FHC7100KNEE1

MOBILECARE STRETCHER WITH KNEE GATCH. PNEUMATIC FOWLER ADJUSTMENT. HEIGHT ADJUST RANGE OF 23" TO 36". PEDALS LOCATED ON EITHER SIDE. +/- 18 DEGREE TRENDELENBURG AND REVERSE TRENDELEBURG, ADJUSTMENT PEDALS ON EITHER SIDE. FOLD FORWARD SIDE RAILS. BUILT IN O2 CYLINDER STORAGE. CENTRAL LOCKING CASTERS. BRAKE/STEER PEDALS LOCATED ON ALL 4 CORNERS. REMOVABLE 2 HOOK I.V. POLE AND 4" FOAM MATTRESS INCLUDED. WEIGHT CAPACITY 550LB
M.A.C. MEDICAL INC.
FHC7100-KNEE
In Commercial Distribution

  • B286FHC7100KNEE1 ()
FHC7100-KNEE

  • Hospital stretcher, manual

Affinity Home with accessories - 07290017249063

Affinity G.J.S with accessories MP
TAVGER LTD
FG00016
In Commercial Distribution

  • 07290017249063 ()


  • Surgical/orthopaedic lavage control unit

Affinity G.J.S with accessories - 07290017249056

Affinity G.J.S with accessories ASS
TAVGER LTD
FG00014
In Commercial Distribution

  • 07290017249056 ()


  • Surgical/orthopaedic lavage control unit

Straight abutment with shoulder - 07290018434543

No Description
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
4mm
In Commercial Distribution

  • 07290018434543 ()
SA4

  • Dental implant system

Straight abutment with shoulder - 07290018434536

No Description
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
3mm
In Commercial Distribution

  • 07290018434536 ()
SA3

  • Dental implant system

Straight abutment with shoulder - 07290018434529

No Description
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
2mm
In Commercial Distribution

  • 07290018434529 ()
SA2

  • Dental implant system

Straight abutment with shoulder - 07290018434512

No Description
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
1mm
In Commercial Distribution

  • 07290018434512 ()
SA1

  • Dental implant system

Navient System with kits - 07540209955501

Navient System 955-NC-NC with kits
ClaroNav Kolahi Inc
955-NC-NC
In Commercial Distribution

  • 07540209955501 ()


  • Neurological stereotactic surgery system

NaviENT system with Kit - 07540209955112

Navient ENT system with kit
ClaroNav Kolahi Inc
955-NE-NE
In Commercial Distribution

  • 07540209955112 ()


  • Neurological stereotactic surgery system

Drill with Centering Sleeve - 00887868270581

No Description
CAYENNE MEDICAL, INC.
CM9640S
In Commercial Distribution

CM9640S

  • Fluted surgical drill bit, reusable

Drill with Centering Sleeve - 00887868270505

No Description
CAYENNE MEDICAL, INC.
CM9620S
In Commercial Distribution

CM9620S

  • Fluted surgical drill bit, reusable

VA 13mm with Silicon - 07290108241105

No Description
WEST PHARMA. SERVICES IL, . LTD
8070314
In Commercial Distribution

  • 07290108241105 ()


  • Vial/bottle adaptor, hermetic

NeuroNav with MER Headstage - 27290114063276

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav with MER Headstage
In Commercial Distribution

  • 27290114063276 ()
NNW-025023-55

  • Depth electrode

NeuroSmart with NeuroFortis Drive - 27290114060435

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart with NeuroFortis Drive
In Commercial Distribution

  • 27290114060435 ()
NSW-026010-55

  • Depth electrode
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