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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Vysis LSI ERBB2 (17q12) SpectrumGreen Probe
ABBOTT MOLECULAR INC.
02N20-020
In Commercial Distribution

  • 00884999002715 ()
02N20-020

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI MAPT 17q21 SpectrumGreen Probe
ABBOTT MOLECULAR INC.
02N19-010
In Commercial Distribution

  • 00884999002708 ()
02N19-010

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI MYC (8q24) SpectrumRed Probe
ABBOTT MOLECULAR INC.
02N12-030
In Commercial Distribution

  • 00884999002623 ()
02N12-030

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI TERC (3q26) SpectrumGold Probe
ABBOTT MOLECULAR INC.
02N11-030
In Commercial Distribution

  • 00884999002609 ()
02N11-030

  • Nucleic acid hybridization detection IVD, probe
UroVysion Bladder Cancer Kit
ABBOTT MOLECULAR INC.
02J27-095
In Commercial Distribution

  • 00884999002180 ()
02J27-095

  • Bladder tumour-associated mutation IVD, probe
UroVysion Bladder Cancer Kit
ABBOTT MOLECULAR INC.
02J27-025
In Commercial Distribution

  • 00884999002142 ()
02J27-025

  • Bladder tumour-associated mutation IVD, probe
ProbeChek UroVysion Bladder Cancer Kit Control Slides
ABBOTT MOLECULAR INC.
02J27-011
In Commercial Distribution

  • 00884999002128 ()
02J27-011

  • Bladder tumour-associated mutation IVD, control
PathVysion HER-2 DNA Probe Kit
ABBOTT MOLECULAR INC.
02J01-036
In Commercial Distribution

  • 00884999001763 ()
02J01-036

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, reagent
PathVysion HER-2 DNA Probe Kit
ABBOTT MOLECULAR INC.
02J01-035
In Commercial Distribution

  • 00884999001756 ()
02J01-035

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, reagent
PathVysion HER-2 DNA Probe Kit
ABBOTT MOLECULAR INC.
02J01-030
In Commercial Distribution

  • 00884999001732 ()
02J01-030

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, reagent
Vysis LSI CCND1 SpectrumGreen Probe
ABBOTT MOLECULAR INC.
01N88-030
In Commercial Distribution

  • 00884999001305 ()
01N88-030

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI Xq13.2 (XIST) SO Probe
ABBOTT MOLECULAR INC.
01N61-001
In Commercial Distribution

  • 00884999000810 ()
01N61-001

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI BCL6 Dual Color Break Apart Rearrangement Probe
ABBOTT MOLECULAR INC.
01N23-020
In Commercial Distribution

  • 00884999000582 ()
01N23-020

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI MDM2 SpectrumOrange Probe
ABBOTT MOLECULAR INC.
01N15-020
In Commercial Distribution

  • 00884999000513 ()
01N15-020

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI D15S10 SO/CEP 15 SA/PML SGn Probes
ABBOTT MOLECULAR INC.
01N13-010
In Commercial Distribution

  • 00884999000483 ()
01N13-010

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI SNRPN SpectrumOrange/CEP 15 SpectrumAqua/PML SpectrumGreen
ABBOTT MOLECULAR INC.
01N12-010
In Commercial Distribution

  • 00884999000476 ()
01N12-010

  • Nucleic acid hybridization detection IVD, probe
ELEVATOR, # 20
BMT Medizintechnik GmbH
LA-20
In Commercial Distribution

  • 04251725213091 ()
LA-20

  • Dental elevator, tooth/root
EXCAVATOR 20
AMERICAN EAGLE INSTRUMENTS, INC.
AEEXC20
In Commercial Distribution

  • 00841013104961 ()


  • Dental excavator, reusable
Composite #20
Zoll-Dental
COMP-20
In Commercial Distribution

  • 00840105200895 ()


  • Dental spatula, reusable
Coleman #20
Zoll-Dental
ELE-Coleman20
In Commercial Distribution

  • 00840105203285 ()


  • Dental elevator, tooth/root
SHUNTASSISTANT 20
Christoph Miethke GmbH & Co. KG
FV251T
In Commercial Distribution

  • 04041906113209 ()
FV251T

  • Cerebrospinal fluid shunt valve
Colorhue #20
FRICKE INTERNATIONAL, INC.
17007-016
In Commercial Distribution

  • B715170070160 ()

  • Weight: 1 Pound
17007-016

  • Dental appliance fabrication material, resin
Colorhue #20
FRICKE INTERNATIONAL, INC.
17007-006
In Commercial Distribution

  • B715170070060 ()

  • Weight: 145 Gram
17007-006

  • Dental appliance fabrication material, resin
Colorhue #20
FRICKE INTERNATIONAL, INC.
17007-002
In Commercial Distribution

  • B715170070020 ()

  • Weight: 48 Gram
17007-002

  • Dental appliance fabrication material, resin
EXCAVATOR #20
J & J INSTRUMENTS INC
04-720
In Commercial Distribution

  • 00817524021608 ()


  • Dental excavator, reusable
Reamer 20
Medacta International SA
2.220
In Commercial Distribution

  • 07630971216129 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
NO. 20
KLS-Martin L.P.
09-020-00-07
In Commercial Distribution

  • 00888118010605 ()


  • Periosteal elevator, reusable
2-0 SUTURETAPE
ARTHREX, INC.
AR-7521
In Commercial Distribution

  • 00888867297999 ()
  • 10888867297996 ()
AR-7521

  • Polyolefin/fluoropolymer suture, multifilament
Excavator #20
POMEE CORPORATION
704-720
In Commercial Distribution

  • G1577047200 ()
704-720

  • Dental excavator, reusable
20 cm
Spiggle & Theis Medizintechnik GmbH
10-720-21
In Commercial Distribution

  • 04250676732378 ()
10-720-21

  • Surgical mallet
FLOWTRON 20
MEDLINE INDUSTRIES, INC.
DVT20R
In Commercial Distribution

  • 20888277378121 ()
  • 10888277378124 ()
  • 80888277378123 ()
DVT20R

  • Single-chamber venous compression system garment, reprocessed
20 cm
Spiggle & Theis Medizintechnik GmbH
20-200-20
In Commercial Distribution

  • 04250381808405 ()
20-200-20

  • Dressing/utility forceps, scissors-like, reusable
20 cm
Spiggle & Theis Medizintechnik GmbH
20-311-20
In Commercial Distribution

  • 04250381894361 ()
20-311-20

  • Bone file/rasp, manual, reusable
20 Packs
Rehabtronics Inc
PR-EL1Ab
In Commercial Distribution

  • 17540176050114 ()
PR-IES1A

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Transcutaneous electrical stimulation electrode, single-use
TSB w/20% Glycerol (5ml) 20/PK
REMEL, INC.
R065029
In Commercial Distribution

  • 00848838010361 ()
R065029

  • General-microorganism antimicrobial susceptibility culture medium IVD
BLUNT BLADE 20 x 20 MM, TEAL
TEDAN SURGICAL INNOVATIONS, L.L.C.
CS-4028
In Commercial Distribution

  • 00843059121810 ()


  • Surgical retractor/retraction system blade, reusable
rematitan® “LITE”, lower, 20 x 20
DENTAURUM GmbH & Co.KG
768-115-00
In Commercial Distribution

  • J011768115000 ()
  • J011768115001 ()


  • Orthodontic archwire
rematitan® “LITE”, upper, 20 x 20
DENTAURUM GmbH & Co.KG
768-114-00
In Commercial Distribution

  • J011768114000 ()
  • J011768114001 ()


  • Orthodontic archwire
Surgical Matrix Thick 20 x 20 cm
ACELL, INC.
PSMT2020
Not in Commercial Distribution

  • 00386190000472 ()

  • Rectangle device approximately 20 x 20 cm
PSMT2020

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Triever 20 Catheter, 20 Fr, 105 cm
INARI MEDICAL INC
21-201
In Commercial Distribution

  • 00850291007215 ()

  • Outer Diameter: 6.5 Millimeter
  • Catheter Working Length: 105 Centimeter


  • Thrombectomy suction catheter
STERILIZATION WRAP 20" x 20" 500/PK
Young Innovations, Inc.
SW-2000
In Commercial Distribution

  • 10840326419462 ()
  • 00840326419465 ()
SW-2000

  • Sterilization packaging, single-use
CSR Wraps 20 x 20 (500) DARBY
DARBY DENTAL SUPPLY, LLC
9508267
In Commercial Distribution

  • 00889813013038 ()
  • 00889813012888 ()
9508267

  • Sterilization packaging, single-use
CSR Wraps 20 x 20 (100) DARBY
DARBY DENTAL SUPPLY, LLC
9508263
In Commercial Distribution

  • 00889813012970 ()
  • 00889813012895 ()
  • 00889813012888 ()
9508263

  • Sterilization packaging, single-use
Adjustable Skin Protection Cushion 20 x 20
KI MOBILITY, LLC
AS
In Commercial Distribution

XAS2020

  • Wheelchair seat cushion
STERILE DISPOSABLE BAND BAGS 20" X 20"
AADCO MEDICAL, INC.
DB-2020E
In Commercial Distribution

  • 00840348525946 ()
DB-2020E

  • Sterilization packaging, single-use
Kölbel Blade, 20 x 20 mm, each
Buxton Biomedical Inc
24-6112
In Commercial Distribution

  • B7682461120 ()
24-6112

  • Self-retaining surgical retractor, reusable
Xpress Staple (20 x 20 x 20mm)
Stryker GmbH
EZXP20-20-20
In Commercial Distribution

  • 07613327357950 ()
EZXP20-20-20

  • Orthopaedic bone staple, non-adjustable
Step OSStaple 20 x 20 x12 W2x3
Biomedical Enterprises, Inc.
OS-2020-12W2x3
In Commercial Distribution

  • 00810633021316 ()

  • Length: 12 Millimeter
  • Length: 20 Millimeter
  • Width: 20 Millimeter


  • Orthopaedic bone staple, non-adjustable
Step OSStaple 20 x 20 x02 W2x3
Biomedical Enterprises, Inc.
OS-2020-02W2x3
In Commercial Distribution

  • 00810633021279 ()

  • Length: 02 Millimeter
  • Length: 20 Millimeter
  • Width: 20 Millimeter


  • Orthopaedic bone staple, non-adjustable
DynaNite® Comp Plate, Segmented, 20/20
ARTHREX, INC.
AR-8771-2020MS
In Commercial Distribution

  • 00888867308534 ()
AR-8771-2020MS

  • Orthopaedic fixation plate, non-bioabsorbable
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