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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LLIF IMPLANT TRIAL, MODULAR, STRAIGHT
HYHTE HOLDINGS, INC.
GZC01D10A
In Commercial Distribution

  • 00840085208645 ()

  • Width: 24 Millimeter
  • Height: 10 Millimeter
  • Angle: 0 degree
GZC01D10A

  • Spinal implant trial
LLIF IMPLANT TRIAL, MODULAR, STRAIGHT
HYHTE HOLDINGS, INC.
GZC01D08A
In Commercial Distribution

  • 00840085208614 ()

  • Width: 24 Millimeter
  • Height: 8 Millimeter
  • Angle: 0 degree
GZC01D08A

  • Spinal implant trial
LLIF IMPLANT TRIAL, MODULAR, STRAIGHT
HYHTE HOLDINGS, INC.
GZC01D07A
In Commercial Distribution

  • 00840085208591 ()

  • Width: 24 Millimeter
  • Height: 7 Millimeter
  • Angle: 0 degree
GZC01D07A

  • Spinal implant trial
LLIF IMPLANT TRIAL, THREADED
HYHTE HOLDINGS, INC.
GZC13D18A
In Commercial Distribution

  • 00841379198123 ()

  • Width: 24 Millimeter
  • Height: 18 Millimeter
  • Angle: 0 degree
GZC13D18A

  • Spinal implant trial
LLIF IMPLANT TRIAL, THREADED
HYHTE HOLDINGS, INC.
GZC13D16A
In Commercial Distribution

  • 00841379198086 ()

  • Width: 24 Millimeter
  • Height: 16 Millimeter
  • Angle: 0 degree
GZC13D16A

  • Spinal implant trial
LLIF IMPLANT TRIAL, THREADED
HYHTE HOLDINGS, INC.
GZC13D14A
In Commercial Distribution

  • 00841379198048 ()

  • Width: 24 Millimeter
  • Height: 14 Millimeter
  • Angle: 0 degree
GZC13D14A

  • Spinal implant trial
LLIF IMPLANT TRIAL, THREADED
HYHTE HOLDINGS, INC.
GZC13D12A
In Commercial Distribution

  • 00841379198000 ()

  • Width: 24 Millimeter
  • Height: 12 Millimeter
  • Angle: 0 degree
GZC13D12A

  • Spinal implant trial
LLIF IMPLANT TRIAL, THREADED
HYHTE HOLDINGS, INC.
GZC13D10A
In Commercial Distribution

  • 00841379197966 ()

  • Width: 24 Millimeter
  • Height: 10 Millimeter
  • Angle: 0 degree
GZC13D10A

  • Spinal implant trial
LLIF IMPLANT TRIAL, THREADED
HYHTE HOLDINGS, INC.
GZC13D08A
In Commercial Distribution

  • 00841379197942 ()

  • Width: 24 Millimeter
  • Height: 8 Millimeter
  • Angle: 0 degree
GZC13D08A

  • Spinal implant trial
LLIF IMPLANT TRIAL, THREADED
HYHTE HOLDINGS, INC.
GZC13D07A
In Commercial Distribution

  • 00841379197935 ()

  • Width: 24 Millimeter
  • Height: 7 Millimeter
  • Angle: 0 degree
GZC13D07A

  • Spinal implant trial
LLIF IMPLANT TRIAL, THREADED
HYHTE HOLDINGS, INC.
GZC13D20A
In Commercial Distribution

  • 00841379189497 ()

  • Width: 24 Millimeter
  • Height: 20 Millimeter
  • Angle: 0 degree
GZC13D20A

  • Spinal implant trial
ATRAMAT POLYPROPYLENE SURGICAL SUTURE BLUE USP 0 EP 3,5, 45 CM NEEDLE PE-24 PREMIUM REVERSE CUTTING 24 MM 3/8 CIRCLE POLIPROPILENO AZUL USP 0, 45 CM AGUJA PE-24 REVERSO CORTANTE PREMIUM 24 MM 3/8 CIRCULO
Internacional Farmacéutica, S.A. de C.V.
POLIPROPILENO
In Commercial Distribution

  • 07500142156380 ()
  • 07500142056383 ()

  • Length: 24 Millimeter
  • 3/8 CIRCLE
  • SUTURE BLUE
  • ATRAMAT POLIPROPYLENE
  • USP 0
PE2461

  • Polyolefin/fluoropolymer suture, monofilament
ATRAMAT NYLON SURGICAL SUTURE BLACK USP 0 EP 3,5, 75 CM NEEDLE PE-24 PREMIUM REVERSE CUTTING 24 MM 3/8 CIRCLE NYLON NEGRO USP 0, 75 CM AGUJA PE-24 REVERSO CORTANTE PREMIUM 24 MM 3/8 CIRCULO
Internacional Farmacéutica, S.A. de C.V.
NYLON
In Commercial Distribution

  • 07500142129421 ()
  • 07500142029424 ()

  • Length: 24 Millimeter
  • 3/8 CIRCLE
  • SUTURE BLACK
  • ATRAMAT NYLON
  • USP 0
PE2441-75N

  • Nylon suture, non-bioabsorbable, monofilament
Lexie Lumen self-fitting Beige hearing aid - Duo
HEARX GROUP (PTY) LTD
Lumen Duo Beige
In Commercial Distribution

  • 10860003469801 ()
  • 00860003469804 ()
Lumen 155

  • Air-conduction hearing aid, behind-the-ear
Lexie Lumen self-fitting Silver hearing aid - Duo
HEARX GROUP (PTY) LTD
Lumen Duo Silver
In Commercial Distribution

  • 10850022464000 ()
  • 00850022464003 ()
Lumen 155

  • Air-conduction hearing aid, behind-the-ear
Nova Max 10 Glucose Test Strips
NOVA BIOMEDICAL CORPORATION
Plus
In Commercial Distribution

  • 10385480436042 ()
  • 00385480436045 ()
43604

  • Glucose monitoring system IVD, home-use
The membrane and the electrolyte of SenTec TC Sensors must be changed periodically. For this purpose the old sensor membrane must be removed, the sensor surface must be cleaned, new electrolyte must be applied and a new sensor membrane must be put on. The patented Membrane Changer (MC) is a tool that allows the user to carry out the whole membrane change process by 4 simple press-and-turn steps. The MC is single-use.
SenTec AG
MC
In Commercial Distribution

  • 07640121880933 ()
  • 17640121880930 ()


  • Transcutaneous blood gas monitoring system
  • Transcutaneous blood gas monitor sensor
  • Pulse Co-oximeter probe, reusable
STERILE DISPOSABLE EQUIPMENT COVER - NO BAND BAG 24" X 24" WITH TAPE
PREFERRED MEDICAL PRODUCTS, LLC
NB-2424 W/T
In Commercial Distribution

  • 30680211002751 ()
  • 00680211002750 ()
  • 10680211002757 ()
NB-2424 W/T

  • Patient surgical drape, single-use
STERILE DISPOSABLE EQUIPMENT COVER - INSTRUMENT POUCH 24" X 24" - LIP, TAPE STRIP
PREFERRED MEDICAL PRODUCTS, LLC
IP-2424-L
In Commercial Distribution

  • 30680211001570 ()
  • 00680211001579 ()
  • 10680211001576 ()
IP-2424-L

  • Patient surgical drape, single-use
CareGUARD Dual Layers, 60cm x 60cm (24" x 24"), 75GSM, Blue/blue
CARE ESSENTIALS PTY LTD
SW606075-B/B
In Commercial Distribution

  • 19332017000697 ()
  • 09332017000690 ()
SW606075-B/B

  • Sterilization packaging, single-use
CareGUARD Dual Layers, 60cm x 60cm (24" x 24"), 60GSM, Blue/blue
CARE ESSENTIALS PTY LTD
SW606060-B/B
In Commercial Distribution

  • 19332017000680 ()
  • 09332017000683 ()
SW606060-B/B

  • Sterilization packaging, single-use
CareGUARD Dual Layers, 60cm x 60cm (24" x 24"), 50GSM, Blue/blue
CARE ESSENTIALS PTY LTD
SW606050-B/B
In Commercial Distribution

  • 19332017000666 ()
  • 09332017000669 ()
SW606050-B/B

  • Sterilization packaging, single-use
CER. BRKT 022 W/HKS 24/PK HY 24 brackets and tubes
PATTERSON DENTAL SUPPLY, INC.
070416073
In Commercial Distribution

  • D6620704160730 ()


  • Orthodontic bracket, ceramic
V. Mueller GENESIS NON-CELLULOSE FILTER 9.5? X 9.5? 24 X 24 CM
STERIS CORPORATION
DST-3
In Commercial Distribution

  • 70885403187485 ()
  • 10885403187483 ()
  • 20885403187480 ()
DST3

  • Sterilization container filter, single-use
ZEROWIRE G2 DUO, WITH ACCESSORIES FOR RADIANCE 24", 26" AND ENDOVUE 24"
Nds Surgical Imaging LLC
90T23001
In Commercial Distribution

  • 00818089022215 ()


  • Medical networking interface unit
RCCPA-LG (PATIENT APRON, .5MM COST CRUNCHER, PATIENT APRON, 24" X 24", LG)
BURLINGTON MEDICAL, LLC
RCCPA-LG
In Commercial Distribution

  • 00840331276138 ()


  • Radiation shielding apron
Thyreoglobulin - IMMULITE - CONS - 3x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385247
In Commercial Distribution

  • 00630414978345 ()
LTYCM(D)

  • Thyroglobulin IVD, control
Thyreoglobulin - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381647
In Commercial Distribution

  • 00630414972084 ()
L2KTY2(D)

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
Camouflage Flowable Enamel, Shade C4, 20 0.2g Capsules
Prismatik Dentalcraft, Inc
70-1152-CMF0018
In Commercial Distribution

  • D745701152CMF00181 ()
  • D745701152CMF00180 ()

  • Weight: 0.2 Gram
70-1152-CMF0018

  • Dental composite resin
Camouflage Flowable Enamel, Shade B1, 20 0.2g Capsules
Prismatik Dentalcraft, Inc
70-1152-CMF0017
In Commercial Distribution

  • D745701152CMF00171 ()
  • D745701152CMF00170 ()

  • Weight: 0.2 Gram
70-1152-CMF0017

  • Dental composite resin
Camouflage Flowable Enamel, Shade A4, 20 0.2g Capsules
Prismatik Dentalcraft, Inc
70-1152-CMF0016
In Commercial Distribution

  • D745701152CMF00161 ()
  • D745701152CMF00160 ()

  • Weight: 0.2 Gram
70-1152-CMF0016

  • Dental composite resin
Camouflage Flowable Enamel, Shade A3.5, 20 0.2g Capsules
Prismatik Dentalcraft, Inc
70-1152-CMF0015
In Commercial Distribution

  • D745701152CMF00151 ()
  • D745701152CMF00150 ()

  • Weight: 0.2 Gram
70-1152-CMF0015

  • Dental composite resin
Camouflage Flowable Enamel, Shade A3, 20 0.2g Capsules
Prismatik Dentalcraft, Inc
70-1152-CMF0014
In Commercial Distribution

  • D745701152CMF00141 ()
  • D745701152CMF00140 ()

  • Weight: 0.2 Gram
70-1152-CMF0014

  • Dental composite resin
Camouflage Flowable Enamel, Shade A2, 20 0.2g Capsules
Prismatik Dentalcraft, Inc
70-1152-CMF0013
In Commercial Distribution

  • D745701152CMF00131 ()
  • D745701152CMF00130 ()

  • Weight: 0.2 Gram
70-1152-CMF0013

  • Dental composite resin
Camouflage Flowable Enamel, Shade A1, 20 0.2g Capsules
Prismatik Dentalcraft, Inc
70-1152-CMF0012
In Commercial Distribution

  • D745701152CMF00121 ()
  • D745701152CMF00120 ()

  • Weight: 0.2 Gram
70-1152-CMF0012

  • Dental composite resin
Camouflage Flowable Enamel, Bleach, 20 0.2g Capsules
Prismatik Dentalcraft, Inc
70-1152-CMF0011
In Commercial Distribution

  • D745701152CMF00111 ()
  • D745701152CMF00110 ()

  • Weight: 0.2 Gram
70-1152-CMF0011

  • Dental composite resin
Camouflage Flowable Dentin, Shade A2, 20 0.2g Capsules
Prismatik Dentalcraft, Inc
70-1152-CMF0010
In Commercial Distribution

  • D745701152CMF00101 ()
  • D745701152CMF00100 ()

  • Weight: 0.2 Gram
70-1152-CMF0010

  • Dental composite resin
Camouflage Flowable Enamel, Shade C4, 4g Syringe
Prismatik Dentalcraft, Inc
70-1152-CMF0009
In Commercial Distribution

  • D745701152CMF00090 ()

  • Weight: 4 Gram
70-1152-CMF0009

  • Dental composite resin
Camouflage Flowable Enamel, Shade B1, 4g Syringe
Prismatik Dentalcraft, Inc
70-1152-CMF0008
In Commercial Distribution

  • D745701152CMF00080 ()

  • Weight: 4 Gram
70-1152-CMF0008

  • Dental composite resin
Camouflage Flowable Enamel, Shade A4, 4g Syringe
Prismatik Dentalcraft, Inc
70-1152-CMF0007
In Commercial Distribution

  • D745701152CMF00070 ()

  • Weight: 4 Gram
70-1152-CMF0007

  • Dental composite resin
Camouflage Flowable Enamel, Shade A3.5, 4g Syringe
Prismatik Dentalcraft, Inc
70-1152-CMF0006
In Commercial Distribution

  • D745701152CMF00060 ()

  • Weight: 4 Gram
70-1152-CMF0006

  • Dental composite resin
Camouflage Flowable Enamel, Shade A3, 4g Syringe
Prismatik Dentalcraft, Inc
70-1152-CMF0005
In Commercial Distribution

  • D745701152CMF00050 ()

  • Weight: 4 Gram
70-1152-CMF0005

  • Dental composite resin
Camouflage Flowable Enamel, Shade A2, 4g Syringe
Prismatik Dentalcraft, Inc
70-1152-CMF0004
In Commercial Distribution

  • D745701152CMF00040 ()

  • Weight: 4 Gram
70-1152-CMF0004

  • Dental composite resin
Camouflage Flowable Enamel, Shade A1, 4g Syringe
Prismatik Dentalcraft, Inc
70-1152-CMF0003
In Commercial Distribution

  • D745701152CMF00030 ()

  • Weight: 4 Gram
70-1152-CMF0003

  • Dental composite resin
Camouflage Flowable Enamel, Bleach , 4g Syringe
Prismatik Dentalcraft, Inc
70-1152-CMF0002
In Commercial Distribution

  • D745701152CMF00020 ()

  • Weight: 4 Gram
70-1152-CMF0002

  • Dental composite resin
Camouflage Flowable Dentin, Shade A2, 4g Syringe
Prismatik Dentalcraft, Inc
70-1152-CMF0001
In Commercial Distribution

  • D745701152CMF00010 ()

  • Weight: 4 Gram
70-1152-CMF0001

  • Dental composite resin
Camouflage Universal Enamel Sample, Shade A2, 3 0.2g Capsules
Prismatik Dentalcraft, Inc
70-1151-CMU0045
In Commercial Distribution

  • D745701151CMU00451 ()
  • D745701151CMU00450 ()

  • Weight: 0.2 Gram
70-1151-CMU0045

  • Dental composite resin
Camouflage Universal Incisal, 20 0.2g Capsules
Prismatik Dentalcraft, Inc
70-1151-CMU0042
In Commercial Distribution

  • D745701151CMU00421 ()
  • D745701151CMU00420 ()

  • Weight: 0.2 Gram
70-1151-CMU0042

  • Dental composite resin
Camouflage Universal Enamel, Shade D4, 20 0.2g Capsules
Prismatik Dentalcraft, Inc
70-1151-CMU0041
In Commercial Distribution

  • D745701151CMU00411 ()
  • D745701151CMU00410 ()

  • Weight: 0.2 Gram
70-1151-CMU0041

  • Dental composite resin
Camouflage Universal Enamel, Shade D3, 20 0.2g Capsules
Prismatik Dentalcraft, Inc
70-1151-CMU0040
In Commercial Distribution

  • D745701151CMU00401 ()
  • D745701151CMU00400 ()

  • Weight: 0.2 Gram
70-1151-CMU0040

  • Dental composite resin
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