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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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G. Aufricht Nasal Retractor Solid Tapered 50 X 6 Millimeter Blade Illuminated
SONTEC INSTRUMENTS, INC.
207-2922L
In Commercial Distribution

  • 00192896111493 ()

  • Length: 6.75 Inch


  • Hand-held surgical retractor, reusable
Needles for easypod auto-injector. Single packed, sterile. For single use only. Non-pyrogenic.
EMD Serono, Inc.
U1244118
Not in Commercial Distribution

  • 04046963413880 ()
  • 04046963413873 ()
  • 04046963413866 ()

  • Needle Gauge: 29 Gauge
16441EMD

  • Autoinjector needle
No Description
DETAX GmbH
03003
Not in Commercial Distribution

  • EDET030031 ()


  • Denture reliner, elastic, long-term
No Description
DETAX GmbH
03001
In Commercial Distribution

  • EDET030011 ()


  • Denture reliner, elastic, long-term
No Description
DETAX GmbH
03000
In Commercial Distribution

  • EDET030001 ()


  • Denture reliner, elastic, long-term
Bioactive mineral Root Canal Sealer
SEPTODONT SAS SPECIALITES SEPTODONT
01E0510
In Commercial Distribution

  • 03701398102556 ()
01E0510

  • Hygroscopic dental cement
Instrument Adaptor 28160 G instrument Rosa One 3.1 (brain application) Ventricular endoscopy instrument adaptor to accomodate ventricular endoscopy instrument holder. Not for drilling"
MEDTECH
174094-01
In Commercial Distribution

  • 03760244033338 ()
ROSAS00326

  • Multi-purpose stereotactic surgery system
Instrument Adaptor 28160 G instrument Rosa 3.0 instrument ROSA3.1 Ventricular endoscopy instrument adaptor to accomodate ventricular endoscopy instrument holder. Not for drilling
MEDTECH
ROSA3-116A
In Commercial Distribution

  • 03760244031242 ()
ROSAS00326

  • Multi-purpose stereotactic surgery system
  • Neurological stereotactic surgery system
Instrument Adaptor 28160 G instrument Rosa One 3.1 (brain application) Ventricular endoscopy instrument adaptor to accomodate ventricular endoscopy instrument holder. Not for drilling"
MEDTECH
174094-00
In Commercial Distribution

  • 03760244031099 ()
ROSAS00326

  • Multi-purpose stereotactic surgery system
Conflow G Bone Cement is a low viscosity antibiotic-loaded polymethylmethacrylate bone cements. It is composed by two components (40g powder and 14,7g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. Conflow G Bone Cement is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
TECRES SPA
110043026
In Commercial Distribution

  • 08031497002101 ()


  • Orthopaedic cement, antimicrobial
Minimax Panoramic G 6X12, Green Sensitive 50/box
Flow X Ray Corporation
20612-G
In Commercial Distribution

  • 00812045032034 ()
  • 00308120450324 ()


  • Dental x-ray film, screen
Minimax Panoramic G 5X12, Green Sensitive 50/box
Flow X Ray Corporation
20512-G
In Commercial Distribution

  • 00812045032010 ()
  • 00300812045030 ()


  • Dental x-ray film, screen
This instrument is used to grasp, retract, or stabilize tissue.
DAUD JEE MFG. CO
D50-31300
In Commercial Distribution

  • G006D50313000 ()
D50-31300

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
SPROTTE® 2.G Standard Sprotte Needle 2nd generation 24G x 4" (103mm), sterile
Pajunk GmbH Medizintechnologie
521251-30A
Not in Commercial Distribution

  • 04048223067703 ()
  • 04048223088289 ()

  • Needle Gauge: 24.0 Gauge
  • Length: 103.0 Millimeter
521251-30A

  • Spinal needle, single-use
No Description
OXOID LIMITED
DR0591G
In Commercial Distribution

  • 05032384013098 ()


  • Beta-haemolytic Streptococcus serological grouping IVD, reagent
No Description
OXOID LIMITED
CM0367B
In Commercial Distribution

  • 05032384002740 ()


  • Differential/selective agar culture medium IVD
No Description
FUJIREBIO INC.
234181
Not in Commercial Distribution

  • 04987270234181 ()

  • Size Type = Units Per Kit; Units = 2; Unit of Measure = 3.0mLs


  • Human epididymis protein 4 (HE4) IVD, calibrator
No Description
FUJIREBIO INC.
233849
In Commercial Distribution

  • 04987270233849 ()

  • Size Type = Units Per Kit; Units = 3; Unit of Measure = 4.5mLs


  • Estradiol (oestradiol) (E2) IVD, calibrator
No Description
FUJIREBIO INC.
233436
In Commercial Distribution

  • 04987270233436 ()

  • Size Type = Units per kit; Units = 3; Unit of Measure = 4.5mLs


  • Soluble mesothelin-related peptide (SMRP) IVD, calibrator
No Description
FUJIREBIO INC.
231197
In Commercial Distribution

  • 04987270231197 ()

  • Total Volume: 600 Milliliter


  • Chemiluminescent substrate reagent IVD
No Description
FUJIREBIO INC.
231173
In Commercial Distribution

  • 04987270231173 ()

  • Total Volume: 1000 Milliliter


  • Buffered wash solution IVD
No Description
FUJIREBIO INC.
231135
Not in Commercial Distribution

  • 04987270231135 ()

  • Size Type = Units per Kit; Units = 3; Unit of Meaure = 4.5mLs


  • Thyroid stimulating hormone (TSH) IVD, calibrator
No Description
FUJIREBIO INC.
231111
In Commercial Distribution

  • 04987270231111 ()

  • Size Type = Units per Kit; Units = 2; Unit of Measure = 3.0mLs


  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, calibrator
No Description
FUJIREBIO INC.
230954
Not in Commercial Distribution

  • 04987270230954 ()

  • Size Type = Units per Kit; Units = 2; Unit of Measure = 3.0mLs


  • Prolactin IVD, calibrator
No Description
FUJIREBIO INC.
230930
Not in Commercial Distribution

  • 04987270230930 ()

  • Size Type = Units per Kit; Units = 2; Unit of Measure 3.0mLs


  • Follicle stimulating hormone (FSH) IVD, calibrator
No Description
FUJIREBIO INC.
230916
Not in Commercial Distribution

  • 04987270230916 ()

  • Size Type = Units per Kit; Units = 2; Unit of Measure = 3.0mLs


  • Luteinizing hormone (LH) IVD, calibrator
No Description
FUJIREBIO INC.
230893
Not in Commercial Distribution

  • 04987270230893 ()

  • Size Type = Units per Kit; Units = 3; Unit of Measure = 4.5mLs


  • Progesterone IVD, calibrator
No Description
FUJIREBIO INC.
230862
In Commercial Distribution

  • 04987270230862 ()

  • Size Type = Units per kit; Units = 6; Unit of Measure = 9.0mLs


  • Total testosterone IVD, calibrator
No Description
FUJIREBIO INC.
230688
In Commercial Distribution

  • 04987270230688 ()

  • Size Type = Units per Kit; Units = 2; Unit of Measure = 3.0mLs


  • Cancer antigen 125 (CA125) IVD, calibrator
No Description
FUJIREBIO INC.
230466
In Commercial Distribution

  • 04987270230466 ()

  • Height: 4 Centimeter
  • Width: 18.5 Centimeter
  • Length: 11.5 Centimeter


  • Laboratory analyser cuvette IVD, single-use
No Description
Brainlab AG
55950-70G
In Commercial Distribution

  • 04056481000967 ()
55950-70G

  • Robotic surgical navigation system
The product is suitable for root canal therapy for root canal cleaning and shaping. Can be reused.
Meta Biomed Co., Ltd.
5080
In Commercial Distribution

  • 08806387850809 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
The product is suitable for root canal therapy for root canal cleaning and shaping. Can be reused.
Meta Biomed Co., Ltd.
5077
In Commercial Distribution

  • 08806387850779 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
The product is suitable for root canal therapy for root canal cleaning and shaping. Can be reused.
Meta Biomed Co., Ltd.
5074
In Commercial Distribution

  • 08806387850748 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
The product is suitable for root canal therapy for root canal cleaning and shaping. Can be reused.
Meta Biomed Co., Ltd.
5083
In Commercial Distribution

  • 08806387850830 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
Thawing and warming device for HPC, blood products, IV solution
Barkey GmbH & Co. KG
US-C&G 2.Gen
In Commercial Distribution

  • 04059201002135 ()
00010340

  • Cryopreserved blood/tissue thawing unit
Thawing and warming device for frozen plasma (FFP, PF24 ,AHF), Whole Blood, RBC and IV solution
Barkey GmbH & Co. KG
US-C&G
In Commercial Distribution

  • 04059201001817 ()
00003475

  • Cryopreserved blood/tissue thawing unit
Data logger for Bravo Chamber Autoclave
Scican Ltd
01-111729
In Commercial Distribution

  • 07540196002387 ()
01-111729

  • Digital storage media
Surgical handpiece
W & H Dentalwerk Bürmoos GmbH
32906850
Not in Commercial Distribution

  • J021329068501 ()
90-6850

  • Dental surgical power tool motorized handpiece/set, electric
Surgical Handpiece
W & H Dentalwerk Bürmoos GmbH
32906810
Not in Commercial Distribution

  • J021329068101 ()
90-6810

  • Dental surgical power tool motorized handpiece/set, electric
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