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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Vsmooth Applicator (LA), VelaShape II
SYNERON MEDICAL LTD
FG70341
Not in Commercial Distribution

  • 07290109950327 ()
FG70341

  • Multi-modality skin/body contouring system
SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 5-Pk, Velashape III
Candela Corporation
KT75672
In Commercial Distribution

  • 00817495024578 ()
KT75672

  • Multi-modality skin/body contouring system
SET W/ UNBONDED TUBING FOR HEATING, Peritoneal Dialysis Set for Neonates
UTAH MEDICAL PRODUCTS, INC.
Set
In Commercial Distribution

  • H67140005170 ()
4000517

  • Peritoneal dialysis system tubing set
FC Applicator
VIORA LTD
VRE2003
In Commercial Distribution

  • 07290016746334 ()
VRE2003

  • Multi-modality skin/body contouring system
BC Applicator
VIORA LTD
VRE2002
In Commercial Distribution

  • 07290016746327 ()
VRE2002

  • Multi-modality skin/body contouring system
ST Applicator
VIORA LTD
VRE2001
In Commercial Distribution

  • 07290016746310 ()
VRE2001

  • Multi-modality skin/body contouring system
Reaction™
VIORA LTD
VRE0110
In Commercial Distribution

  • 07290016746303 ()
VRE0110

  • Multi-modality skin/body contouring system
The remOVE DC Impulse Generator is part of the remOVE System and is a medical electrical device for fragmentation of OTSC and FTRD clips made by Ovesco Endoscopy AG for the digestive tract • design ensures a direct pulse only when sufficient contact with a segment of the clip is established • required accessories for operating the remOVE DC Impulse are: DC Impulse generator | foot-activated switch with connector cable | power cord | DC cord in order to connect the DC Cutter (part of remOVE DC Cutter Set) • can only be used in combination with remOVE DC Cutter Set
Ovesco Endoscopy AG
400.01
In Commercial Distribution

  • 04260206310563 ()
400.01

  • Gastrointestinal endoscopic clip cutter generator
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-043585-00
In Commercial Distribution

  • 06944904090085 ()


  • Gel warmer
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-043584-00
In Commercial Distribution

  • 06944904090078 ()


  • Gel warmer
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-037334-00
In Commercial Distribution

  • 06944904089812 ()


  • Gel warmer
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-037333-00
In Commercial Distribution

  • 06944904089805 ()


  • Gel warmer
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-027712-01
In Commercial Distribution

  • 06944904089799 ()


  • Gel warmer
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-024667-01
In Commercial Distribution

  • 06944904062341 ()


  • Gel warmer
UltraWarmer Ultrasound Gel Warmer for one: 250ml bottle. Red.
PHARMACEUTICAL INNOVATIONS INC
UltraWarmer Gel Warmer - Red
In Commercial Distribution

  • 10300361100034 ()
  • 00300361100037 ()
36-1100-03

  • Gel warmer
UltraWarmer Ultrasound Gel Warmer for one: 250ml bottle. Navy.
PHARMACEUTICAL INNOVATIONS INC
UltraWarmer Gel Warmer - Navy
In Commercial Distribution

  • 10300361100027 ()
  • 00300361100020 ()
36-1100-02

  • Gel warmer
UltraWarmer Ultrasound Gel Warmer for one: 250ml bottle. White.
PHARMACEUTICAL INNOVATIONS INC
UltraWarmer Gel Warmer - White
In Commercial Distribution

  • 10300361100010 ()
  • 00300361100013 ()
36-1100-01

  • Gel warmer
No Description
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
UGW-01
In Commercial Distribution

  • 06971355420796 ()


  • Gel warmer
Coleman Bassinet 31"W X 38 1/2"H X 17 3/4"D w/Open Cabinet
Blickman Industries, LLC
8049SS
In Commercial Distribution

  • 00850038811976 ()
1118049000

  • Neonatal bed
Coleman Bassinet 31"W X 38 1/2"H X 17 3/4"D w/Closed Cabinet
Blickman Industries, LLC
8048SS
In Commercial Distribution

  • 00850038811969 ()
1118048000

  • Neonatal bed
Coleman Bassinet 31"W X 38 1/2"H X 17 3/4"D w/(1) Drawer
Blickman Industries, LLC
8047SS
In Commercial Distribution

  • 00850038811952 ()
1118047000

  • Neonatal bed
Coleman Bassinet 31"W X 38 1/2"H X 17 3/4"D w/(2) Shelves
Blickman Industries, LLC
8044SS
In Commercial Distribution

  • 00850038811945 ()
1118044000

  • Neonatal bed
Guardian Rise II Bassinet w/Pass-Through Charting Surface
MEDVIRON LLC
Guardian Rise II Bassinet
In Commercial Distribution

  • 00851477007265 ()
M09-0000-0000

  • Neonatal bed
Bassinet Mattress Service Part
MEDVIRON LLC
Bassinet Mattress Service Part
In Commercial Distribution

  • 00851477007258 ()
516-0000-0000

  • Neonatal bed
Bassinet Tub Service Part
MEDVIRON LLC
Bassinet Tub Service Part
In Commercial Distribution

  • 00851477007241 ()
523-0150-0000

  • Neonatal bed
Static Height Bassinet
MEDVIRON LLC
Guardian Static Height Bassinet
In Commercial Distribution

  • 00851477007234 ()
M22-0000-0000

  • Neonatal bed
Height Adjustable Bassinet
MEDVIRON LLC
Guardian Rise Bassinet
In Commercial Distribution

  • 00851477007227 ()
M06-0000-0000

  • Neonatal bed
BASSINET, STAINLESS STEEL, NEWBORN SERIES; WOOD FRONT W/ DRAWER/BOTTOM; FINISH: BROWN SUGAR
NOVUM MEDICAL PRODUCTS INC
NB-WFXD-3DL-BRS
In Commercial Distribution

  • 00850022426513 ()


  • Neonatal bed
The NeoLight Bassinet Basket is a component of a non-powered medical bassinet, intended to work effortlessly with Stryker’s Nära Bassinet’s wheeled base and mattress, offering an adjustable sleeping surface for infants. Constructed from clear, durable, BPA-free high-impact resistant plastic, the basket features an open top and four fixed walls to securely hold the pediatric patient.
NEOLIGHT LLC
300063
In Commercial Distribution

  • 00852788008217 ()
NEO-BASK

  • Neonatal bed
The NeoLight Bassinet Basket Loaner is a component of a non-powered medical bassinet, intended to work effortlessly with Stryker’s Nära Bassinet’s wheeled base and mattress, offering an adjustable sleeping surface for infants. Constructed from clear, durable, BPA-free high-impact resistant plastic, the basket features an open top and four fixed walls to securely hold the pediatric patient.
NEOLIGHT LLC
300064
In Commercial Distribution

  • 00852788008101 ()
NEO-BASK-LNR

  • Neonatal bed
Wood Face Bassinet, Closed Cabinet, 3D Laminate
NOVUM MEDICAL PRODUCTS INC
NB-WFxCC-3DL
In Commercial Distribution

  • 00850925007116 ()
NB-WFxCC-3DL

  • Neonatal bed
Millenium Bassinet
NOVUM MEDICAL PRODUCTS INC
9000X17T
In Commercial Distribution

  • 00850925007109 ()
9000X17T

  • Neonatal bed
Wood Face Bassinet, Drawer, Cabinet 3D Laminate
NOVUM MEDICAL PRODUCTS INC
NB-WFxDC-3DL
In Commercial Distribution

  • 00850925007093 ()
NB-WFxDC-3DL

  • Neonatal bed
Wood Face Bassinet, Drawer, 3D Laminate
NOVUM MEDICAL PRODUCTS INC
NB-WFxD-3DL
In Commercial Distribution

  • 00850925007086 ()
NB-WFxD-3DL

  • Neonatal bed
Carbon Steel Bassinet, Bottom Shelf
NOVUM MEDICAL PRODUCTS INC
NB-CSXB
In Commercial Distribution

  • 00850925007079 ()
NB-CSXB

  • Neonatal bed
Carbon Steel Bassinet
NOVUM MEDICAL PRODUCTS INC
NB-CSX
In Commercial Distribution

  • 00850925007062 ()
NB-CSX

  • Neonatal bed
Stainless Steel Bassinet, End Drawer
NOVUM MEDICAL PRODUCTS INC
NB-SSxED
In Commercial Distribution

  • 00850925007055 ()
NB-SSxED

  • Neonatal bed
Stainless Steel Bassinet, Drawer, Cabinet
NOVUM MEDICAL PRODUCTS INC
NB-SSxDC
In Commercial Distribution

  • 00850925007048 ()
NB-SSxDC

  • Neonatal bed
Stainless Steel Bassinet, Drawer
NOVUM MEDICAL PRODUCTS INC
NB-SSxD
In Commercial Distribution

  • 00850925007031 ()
NB-SSxD

  • Neonatal bed
Stainless Steel Bassinet, Closed Cabinet
NOVUM MEDICAL PRODUCTS INC
NB-SSxCC
In Commercial Distribution

  • 00850925007024 ()
NB-SSxCC

  • Neonatal bed
Stainless Steel Bassinet
NOVUM MEDICAL PRODUCTS INC
NB-SSxB
In Commercial Distribution

  • 00850925007017 ()
NB-SSxB

  • Neonatal bed
Stainless Steel Bassinet, Open Cabinet
NOVUM MEDICAL PRODUCTS INC
NB-SSxOC
In Commercial Distribution

  • 00850925007000 ()
NB-SSxOC

  • Neonatal bed
Infant Series Crib, 2 Side Drop, Fowler Crank Deck, Chrome
NOVUM MEDICAL PRODUCTS INC
C1980FWCR
In Commercial Distribution

  • 00850925007680 ()


  • Neonatal bed
Wooden Bassinet, 2 Drawer, Pull out Shelf
NOVUM MEDICAL PRODUCTS INC
9201-C
In Commercial Distribution

  • 00850925007505 ()
9201-C

  • Neonatal bed
Wood Face Bassinet, Two Drawer, 3D Laminate
NOVUM MEDICAL PRODUCTS INC
NB-WFx2D-3DL
In Commercial Distribution

  • 00850925007482 ()
NB-WFx2D-3DL

  • Neonatal bed
Wood Face Bassinet, Drawer, Cabinet, Melamine
NOVUM MEDICAL PRODUCTS INC
NB-WFxDC-M
In Commercial Distribution

  • 00850925007468 ()
NB-WFxDC-M

  • Neonatal bed
No Description
ATOM MEDICAL CORPORATION
60387
In Commercial Distribution

  • 04942962603874 ()

  • Depth: 960 Millimeter
  • Width: 460 Millimeter
60387

  • Neonatal bed
Washer-Pasteurizer/High Level Disinfector
CENORIN, L.L.C.
610
In Commercial Distribution

  • 00852494007078 ()


  • Pasteurization water bath
Washer-Pasteuerizer/High Level Disinfector
CENORIN, L.L.C.
610HT
In Commercial Distribution

  • 00852494007085 ()


  • Pasteurization water bath
The HALO Hospital Bassinest is designed to be a sleeping surface for infant/newborn patients. The top surface of the device raises and lowers to allow easier access to the infant/newborn. The HALO Hospital Bassinest was also designed for in-hospital transport within newborn labor/delivery units, postpartum units, medical surgical units treating high risk pregnancy patients, NICU’s, and any other patient areas within a hospital where a newborn infant may be treated and/or cared for during hospital admissions. This product is NOT INTENDED for patients that can crawl or reposition themselves independently
HALO INNOVATIONS, INC.
3957
In Commercial Distribution

  • 00818771039606 ()


  • Neonatal bed
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