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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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NeoBeat Newborn Heart Rate Meter - 07045432118322

NeoBeat is a heart rate measurement device using dry-electrode technology, with integrated digital display.
Laerdal Medical AS
532-01001
In Commercial Distribution

  • 07045432118322 ()
532-01001

  • Wearable neonatal heart rate meter

NeoBeat Mini Newborn Heart Rate Meter - 07045432118308

NeoBeat is a heart rate measurement device using dry-electrode technology, with integrated digital display.
Laerdal Medical AS
531-01001
In Commercial Distribution

  • 07045432118308 ()
531-01001

  • Wearable neonatal heart rate meter

NeoBeat Sys Newborn Heart Rate Meter - 07045432112511

NeoBeat is a heart rate measurement device using dry-electrode technology, with integrated digital display.
Laerdal Medical AS
532-00001
In Commercial Distribution

  • 07045432112511 ()
532-00001

  • Wearable neonatal heart rate meter

TDA - 03573026099596

TDA is a reagent associated to API 20 E (20 100/20 160), API® 10 S (10 100)
BIOMERIEUX SA
70402
In Commercial Distribution

  • 03573026099596 ()


  • Multiple Enterobacteriaceae species culture isolate identification IVD, reagent

HeadFrame Kit w/20 Short + 20 Long Head Screws - 00858086006306

Contains one 10858086006280 Cranial Screws, Case of 10 Boxes of 2 Short + 2 Long and one 00858086006252 Headframe Kit
VARIAN MEDICAL SYSTEMS, INC.
P1006805005
In Commercial Distribution

  • 00858086006306 ()


  • Stereotactic radiosurgical invasive head frame

AnchorKnot Knot Pusher (2-0) and AnchorKnot Suture Cutter (2-0) - 00685447001751

No Description
Baylis Médicale Cie Inc
PSZ-400-311
Not in Commercial Distribution

  • 00685447001751 ()


  • Arthroscopic surgical procedure kit, non-medicated, single-use

MEMORY ® 20MEMORY STAPLE WIDTH : 20 MM 20/23 - 08426750031361

No Description
Biomet Orthopedics, LLC
P3720
In Commercial Distribution

  • 08426750031361 ()
P3720

  • Orthopaedic bone staple, non-adjustable

Child Bib Apron With Collar .3mm 20" X 20" - 00812045038784

Child Bib Apron With Collar .3mm Shimmering Green20" X 20"
Flow X Ray Corporation
75053-38
In Commercial Distribution

  • 00812045038784 ()


  • Patient radiation shielding pad/drape, reusable

Konica Minolta SW Opal (Acquire), 20/20 Opal (Acquire) - 00817100020414

Software, Opal Acquire Image Acquisition Software.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ-04-01-00-000
In Commercial Distribution

  • 00817100020414 ()


  • Diagnostic x-ray digital imaging system workstation application software

HCG Pregnancy Serum/Urine Combo Test Cassette (20/20) - 06952804801847

No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801847 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

Hudson RCI - 14026704611321

Contains 20 AQUAPAK 400 SW, 440 ML and 20 NEBULIZER ADAPTOR 033
TELEFLEX INCORPORATED
IPN044362
In Commercial Distribution

  • 14026704611321 ()
404433

  • Inhalation therapy sterile water

HUDSON RCI - 14026704628558

Contains 20 AQUAPAK 1045 HNS, 1070 ML and 20 NEBULIZER ADAPTOR 028
TELEFLEX INCORPORATED
IPN049246
In Commercial Distribution

  • 14026704628558 ()
404435

  • Inhalation therapy sterile water

HUDSON RCI - 14026704611338

Contains 20 AQUAPAK 1045 HNS, 1070 ML and 20 NEBULIZER ADAPTOR 028
TELEFLEX INCORPORATED
IPN044363
In Commercial Distribution

  • 14026704611338 ()
404435

  • Inhalation therapy sterile water

Easy Wipeable Black cover - 00643293015186

Trulife Relax Wheelchair Cover, Relax Easy With Black Cover 20" x 20"
TRULIFE LIMITED
EC004 - 2020
In Commercial Distribution

  • 00643293015186 ()


  • Medical cushion cover

Synthacer - 04250971403201

Synthacer® 300 block, "negative", HA, 20 x 20 x 15 mm
medArtis Medizinprodukte und Forschung Aktiengesellschaft
T6N1MM20-1
In Commercial Distribution

  • 04250971403201 ()

  • Pore Size: 300 Micrometer
  • Length: 15 Millimeter
  • Height: 20 Millimeter
  • Width: 20 Millimeter
6.N1MM20

  • Bone matrix implant, synthetic, non-antimicrobial

Synthacer - 04250971402587

Synthacer® 600 block, "negative", HA, 20 x 20 x 15 mm
medArtis Medizinprodukte und Forschung Aktiengesellschaft
T6N2MM20-1
In Commercial Distribution

  • 04250971402587 ()

  • Width: 20 Millimeter
  • Height: 20 Millimeter
  • Length: 15 Millimeter
  • Pore Size: 600 Micrometer
6.N2MM20

  • Bone matrix implant, synthetic, non-antimicrobial

Syntricer - 04250971407810

Syntricer® 1000 block, "negative", TCP, 20 x 20 x 15 mm
medArtis Medizinprodukte und Forschung Aktiengesellschaft
T7N3MM20-1
In Commercial Distribution

  • 04250971407810 ()

  • Pore Size: 1000 Micrometer
  • Length: 15 Millimeter
  • Width: 20 Millimeter
  • Height: 20 Millimeter
7.N3MM20

  • Bone matrix implant, synthetic, non-antimicrobial

Syntricer - 04250971407209

Syntricer® 300 block, "negative", TCP, 20 x 20 x 15 mm
medArtis Medizinprodukte und Forschung Aktiengesellschaft
T7N1MM20-1
In Commercial Distribution

  • 04250971407209 ()

  • Height: 20 Millimeter
  • Width: 20 Millimeter
  • Length: 15 Millimeter
  • Pore Size: 300 Micrometer
7.N1MM20

  • Bone matrix implant, synthetic, non-antimicrobial

Syntricer - 04250971406592

Syntricer® 600 block, "negative", TCP, 20 x 20 x 15 mm
medArtis Medizinprodukte und Forschung Aktiengesellschaft
T7N2MM20-1
In Commercial Distribution

  • 04250971406592 ()

  • Height: 20 Millimeter
  • Width: 20 Millimeter
  • Length: 15 Millimeter
  • Pore Size: 600 Micrometer
7.N2MM20

  • Bone matrix implant, synthetic, non-antimicrobial

Synthacer - 04250971403829

Synthacer® 1000 block, "negative", HA, 20 x 20 x 15 mm
medArtis Medizinprodukte und Forschung Aktiengesellschaft
T6N3MM20-1
In Commercial Distribution

  • 04250971403829 ()

  • Pore Size: 1000 Micrometer
  • Length: 15 Millimeter
  • Height: 20 Millimeter
  • Width: 20 Millimeter
6.N3MM20

  • Bone matrix implant, synthetic, non-antimicrobial

Guenter Bissinger Medizintechnik GmbH - 04250418723121

Scissor-Electr. 20 cm curved w/TC-blade f. detach. coagulation forceps 20 cm
Günter Bissinger Medizintechnik GmbH
85500068
In Commercial Distribution

  • 04250418723121 ()
85500068

  • Endoscopic electrosurgical handpiece/electrode, bipolar, reusable

Spex Limited - 09420082601208

Constructa Flex Wipedown Cover Only, 20" Wide x 20" Deep, Superhigh Contour
SPEX LIMITED
1102-2020-FSS-W
In Commercial Distribution

  • 09420082601208 ()


  • Wheelchair seat cushion

Spex Limited - 09420082601154

Constructa Shape Wipedown Cover Only, 20" Wide x 20" Deep, Superhigh Contour
SPEX LIMITED
1102-2020-0SS-W
In Commercial Distribution

  • 09420082601154 ()


  • Wheelchair seat cushion

Spex Limited - 09420051789852

Spex Classic Back Support Outer Cover 20"w 20"h (000 Black)
SPEX LIMITED
1255-2020-0SS-C
In Commercial Distribution

  • 09420051789852 ()


  • Wheelchair back rest

Varian Head Frame Package - 00899475002196

Head Frame Kit, Couch Adapter, SCCB, 20 Short + 20 Long Cranial Screws
VARIAN MEDICAL SYSTEMS, INC.
P1006805002
Not in Commercial Distribution

  • 00899475002196 ()


  • Stereotactic radiosurgical invasive head frame

TNT - D798DNTL20201

Tried and True (TNT) Damon Nickel Titanium Lower Archwires 20 x 20
RELIANCE ORTHODONTIC PRODUCTS INC
DNTL2020
In Commercial Distribution

  • D798DNTL20201 ()
  • D798DNTL20200 ()
DNTL2020

  • Orthodontic wire

XYL - 03573026588748

XYL is a reagent associated to API 20 A® (20 300)
BIOMERIEUX SA
XYL
In Commercial Distribution

  • 03573026099879 ()
  • 03573026588748 ()


  • Multiple anaerobic bacteria species culture isolate identification IVD, reagent

EHR - 03573026099862

EHR is a reagent associated to API 20 A® (20 300)
BIOMERIEUX SA
70520
In Commercial Distribution

  • 03573026099862 ()


  • Multiple anaerobic bacteria species culture isolate identification IVD, reagent

Battalion - 00840967187556

Battalion, LLIF Trial, 15°, 20 mm Wide, 20 mm X 90 mm
ALPHATEC SPINE, INC.
27438-103-2020
In Commercial Distribution

  • 00840967187556 ()

  • Height: 20 Millimeter
  • Length: 90 Millimeter
  • Angle: 15 degree
  • Width: 20 Millimeter


  • Spinal implant trial

Battalion - 00840967188621

Battalion, LLIF Trial, 0°, 20 mm Wide, 20 mm X 90 mm
ALPHATEC SPINE, INC.
27438-100-2020
In Commercial Distribution

  • 00840967188621 ()

  • Length: 90 Millimeter
  • Height: 20 Millimeter
  • Width: 20 Millimeter


  • Spinal implant trial

Battalion - 00840967186900

Battalion, LLIF Trial, 10°, 20 mm Wide, 20 mm X 90 mm
ALPHATEC SPINE, INC.
27438-101-2020
In Commercial Distribution

  • 00840967186900 ()

  • Length: 90 Millimeter
  • Width: 20 Millimeter
  • Height: 20 Millimeter
  • Angle: 10 degree


  • Spinal implant trial

Shur-Clens - 10850073677015

Carton containing 20 containers of 20 mL each 0.05% Chlorhexidine Gluconate Solution
Asept Pak, Inc.
980101
In Commercial Distribution

  • 20850073677012 ()
  • 10850073677015 ()
  • 00850073677018 ()


  • Pressure-regulated wound irrigation solution applicator, manual

DRIVEMEDICAL - 00822383933986

PowerMid Wheel Product Description: Titan AXS 20" x 20" Capt. Seat Assemb
Drive Devilbiss Healthcare
TITANAXS-06
In Commercial Distribution

  • 00822383933986 ()


  • Electric-motor-driven wheelchair, occupant-controlled

DRIVEMEDICAL - 00822383542003

PowerPower Front Wheel Product Description: Titan K0821 FWD 20" x 20" Capt.Seat
Drive Devilbiss Healthcare
TITAN2020
Not in Commercial Distribution

  • 00822383542003 ()


  • Electric-motor-driven wheelchair, occupant-controlled

Child Bib Apron With Attached Collar .25mm, 20" X 20" - 00812045038944

Child Bib Apron With Attached Collar, .25mm, 20" X 20" Anti-Microbial Blue
Flow X Ray Corporation
75053NL-42
In Commercial Distribution

  • 00812045038944 ()


  • Patient radiation shielding pad/drape, reusable

Child Bib Apron With Attached Collar .25mm, 20" X 20" - 00812045038937

Child Bib Apron With Attached Collar, .25mm, 20" X 20" Electric Blue
Flow X Ray Corporation
75053NL-39
In Commercial Distribution

  • 00812045038937 ()


  • Patient radiation shielding pad/drape, reusable

Child Bib Apron With Attached Collar .25mm, 20" X 20" - 00812045038920

Child Bib Apron With Attached Collar, .25mm, 20" X 20" Shimmering Green
Flow X Ray Corporation
75053NL-38
In Commercial Distribution

  • 00812045038920 ()


  • Patient radiation shielding pad/drape, reusable

Child Bib Apron With Attached Collar .25mm, 20" X 20" - 00812045038906

Child Bib Apron With Attached Collar, .25mm, 20" X 20" Paw Print
Flow X Ray Corporation
75053NL-34
In Commercial Distribution

  • 00812045038906 ()


  • Patient radiation shielding pad/drape, reusable

Child Bib Apron With Attached Collar .25mm, 20" X 20" - 00812045038890

Child Bib Apron With Attached Collar, .25mm, 20" X 20" Tye Dye
Flow X Ray Corporation
75053NL-30
In Commercial Distribution

  • 00812045038890 ()


  • Patient radiation shielding pad/drape, reusable

Child Bib Apron With Attached Collar .25mm, 20" X 20" - 00812045038869

Child Bib Apron With Attached Collar, .25mm, 20" X 20" Navy Blue
Flow X Ray Corporation
75053NL-22
In Commercial Distribution

  • 00812045038869 ()


  • Patient radiation shielding pad/drape, reusable
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