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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Zone Air Nylon 6 x 35.5 x 84 Cover (tube at foot)
CASCO MANUFACTURING SOLUTIONS, INC.
H10346
In Commercial Distribution

  • 00815073021681 ()
H10346

  • Waterproof bed mattress cover, reusable
Zone Air Urethane 6 x 35.5 x 84 Cover (tube at foot)
CASCO MANUFACTURING SOLUTIONS, INC.
H10269
In Commercial Distribution

  • 00815073021643 ()
H10269

  • Waterproof bed mattress cover, reusable
3.4 mm Arthroscopic Sidebiter, 90 Degrees angled at tip, Right, without Scoop
Surgical Direct, Inc.
SD20909
In Commercial Distribution

  • B382SD209090 ()
SD20909

  • Endoscope sheath, reusable
EasyRelease, ComPel Isolation Gown, AAMI Level 2, Bound Neck, Velcro Hook & Loop Closure at Neck, Tie Closure at Waist, Long Sleeves with Natural White Non-Linting Cuffs, size XL
STANDARD TEXTILE CO., INC.
661Y5044
In Commercial Distribution

  • 01634916814520 ()
  • 00634916814521 ()


  • Isolation gown, reusable
The ROG is a chemical based portable oxygen generator which generates 99% oxygen for at least 15 minutes at a flow rate of at least 6 Lpm. It is a self-contained device with the oxygen delivered via standard oxygen face mask or nasal cannula.
MOLECULAR PRODUCTS LIMITED
EO209P63N29
In Commercial Distribution

  • 05060031380019 ()
  • 05060031380002 ()


  • Emergency oxygen production unit, reusable
Riester binocular loupes are used to enlarge the examination field.
Rudolf Riester GmbH
3982-635
In Commercial Distribution

  • 04045396160804 ()
3982-635

  • Surgical binoculars, reusable
Riester binocular loupes are used to enlarge the examination field.
Rudolf Riester GmbH
3981-635
In Commercial Distribution

  • 04045396160774 ()
3981-635

  • Surgical binoculars, reusable
Riester binocular loupes are used to enlarge the examination field.
Rudolf Riester GmbH
3980-635
In Commercial Distribution

  • 04045396160743 ()
3980-635

  • Surgical binoculars, reusable
Riester binocular loupes are used to enlarge the examination field.
Rudolf Riester GmbH
3972-630
In Commercial Distribution

  • 04045396160729 ()
3972-630

  • Surgical binoculars, reusable
Riester binocular loupes are used to enlarge the examination field.
Rudolf Riester GmbH
3960-625
In Commercial Distribution

  • 04045396160613 ()
3960-625

  • Surgical binoculars, reusable
No Description
Astar Orthodontics Inc.
MG20-55-3H
In Commercial Distribution

  • 06941673528603 ()


  • Orthodontic bracket, metal
No Description
Astar Orthodontics Inc.
MG20-55-345H
In Commercial Distribution

  • 06941673528610 ()


  • Orthodontic bracket, metal
No Description
CHURCH & DWIGHT CO., INC.
00311917184616
In Commercial Distribution

  • 00311917184616 ()


  • Sexual lubricant
No Description
KATALYST SURGICAL LLC
8516
In Commercial Distribution

  • 00840096200829 ()


  • Corneal marker, reusable
No Description
KATALYST SURGICAL LLC
8515
In Commercial Distribution

  • 00840096200812 ()


  • Corneal marker, reusable
Spring Retractor, Stainless Steel, Pointed Tips “Sharp”, .300 Loop Thumb Tab on each side, 4” Width at Distal Tips, 4-1/2” Arm Length, Additional Spec’s on File at Elmed
ELMED INCORPORATED
18-32025
In Commercial Distribution

  • 00198506083723 ()
18-32025

  • Hand-held surgical retractor, reusable
Cottle Chisel, 7 1/4", 9mm, depth markings at 20, 30, 40, & 50mm
Avalign Technologies, Inc.
1-410292
In Commercial Distribution

  • 00190776402037 ()


  • Plastic surgery osteotome
Cottle Chisel, 7 1/4", 7mm, depth markings at 20, 30, 40, & 50mm
Avalign Technologies, Inc.
1-410291
In Commercial Distribution

  • 00190776402020 ()


  • Plastic surgery osteotome
Cottle Chisel, 7 1/4", 4mm, depth markings at 20, 30, 40, & 50mm
Avalign Technologies, Inc.
1-410290
In Commercial Distribution

  • 00190776382223 ()


  • Plastic surgery osteotome
RBP-100 is a non-invasive blood pressure monitors for measuring at the upper arm
Rudolf Riester GmbH
1742
In Commercial Distribution

  • 04045396214590 ()
1742

  • Automatic-inflation electronic sphygmomanometer, non-portable
RBP-100 is a non-invasive blood pressure monitors for measuring at the upper arm
Rudolf Riester GmbH
1743
In Commercial Distribution

  • 04045396208971 ()
1743

  • Automatic-inflation electronic sphygmomanometer, non-portable
RBP-100 is a non-invasive blood pressure monitors for measuring at the upper arm
Rudolf Riester GmbH
1741
In Commercial Distribution

  • 04045396208858 ()
1741

  • Automatic-inflation electronic sphygmomanometer, non-portable
RBP-100 is a non-invasive blood pressure monitors for measuring at the upper arm
Rudolf Riester GmbH
1740
In Commercial Distribution

  • 04045396208797 ()
1740

  • Automatic-inflation electronic sphygmomanometer, non-portable
Sterile transparent PVC suction tube with 2 connectors at the extremities. Length: 2.70m
HYGITECH
HY-12025
In Commercial Distribution

  • 03615140001915 ()
  • 03615140001908 ()
  • 03615140001922 ()
HY-12025

  • Airway suction catheter
Vaginal Packing x ray detectable loop stitched at one end 2" x 72"
Dermapac Inc.
5551
In Commercial Distribution

  • 00810102270481 ()
  • 10810102270488 ()


  • Radiopaque woven surgical sponge
PureSkin Latex Powder-Free, X-Large, Fully-textured, Polymer-coated, Packaging contains at least 70% recycled material
PURELIFE, LLC
1020105
In Commercial Distribution

  • D79010201050 ()
  • D79010201051 ()
1020105

  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
PureSkin Latex Powder-Free, Large, Fully-textured, Polymer-coated, Packaging contains at least 70% recycled material
PURELIFE, LLC
1020104
In Commercial Distribution

  • D79010201040 ()
  • D79010201041 ()
1020104

  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
PureSkin Latex Powder-Free, Medium, Fully-textured, Polymer-coated, Packaging contains at least 70% recycled material
PURELIFE, LLC
1020103
In Commercial Distribution

  • D79010201030 ()
  • D79010201031 ()
1020103

  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
PureSkin Latex Powder-Free, Small, Fully-textured, Polymer-coated, Packaging contains at least 70% recycled material
PURELIFE, LLC
1020102
In Commercial Distribution

  • D79010201020 ()
  • D79010201021 ()
1020102

  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
PureSkin Latex Powder-Free, X-Small, Fully-textured, Polymer-coated, Packaging contains at least 70% recycled material
PURELIFE, LLC
1020101
In Commercial Distribution

  • D79010201010 ()
  • D79010201011 ()
1020101

  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Potts-Smith Tissue Forceps 8-1/4" (20.6cm), 1x2 teeth, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-162NC
In Commercial Distribution

  • 00840319739754 ()
120-162NC

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Adson Dura & Dissecting Hook 8" (20cm), sharp blade 5mm at a right angle
Hayden Medical, Inc.
210-168
In Commercial Distribution

  • 00840319744550 ()
210-168

  • Soft-tissue surgical hook, reusable
Reverdin Suture Passing Needle 6" (15cm), slightly curved with 2mm hole at tip
Hayden Medical, Inc.
405-695
In Commercial Distribution

  • 00840319751084 ()
405-695

  • Suture kit, medicated
Reverdin Suture Passing Needle 8-1/4" (21cm), curved with 2mm hole at tip
Hayden Medical, Inc.
405-698
In Commercial Distribution

  • 00840319751114 ()
405-698

  • Suture kit, medicated
Tweezers with the characteristics of the R-55 packing instrument incorporated at the tips.
PASCAL COMPANY, INC.
26200
In Commercial Distribution

  • 00310866002460 ()


  • Gingival retraction cord packing tool
Electrical Hospital Bed Accessory to be used for patient traction at medical institutions
PARAMOUNT BED CO., LTD.
PC-5121
In Commercial Distribution

  • 04527799701513 ()


  • Bed traction frame
Electrical Hospital Bed Accessory to be used for patient traction at medical institutions.
PARAMOUNT BED CO., LTD.
KA-86U
In Commercial Distribution

  • 04527799700387 ()


  • Bed traction frame
Electrical Hospital Bed Accessory to be used for patient traction at medical institutions.
PARAMOUNT BED CO., LTD.
KA-83U
In Commercial Distribution

  • 04527799700370 ()


  • Bed traction frame
microTargeting Insertion Tube with Stylet, nonsterile, at target, for use with Nexframe/Nexdrive
FHC, INC.
66-IT(DB12)-00521
In Commercial Distribution

  • 00873263005217 ()

  • Lumen/Inner Diameter: 1.6 Millimeter
  • Outer Diameter: 1.83 Millimeter
  • Length: 211.6 Millimeter
66-IT(DB12)

  • Intracerebral cannula, implantable
Surgical Gown, Level 4, snaps at neck, tie waist, military neckband, Size 2XL
Lac-Mac Limited
005XXCA-2XL
In Commercial Distribution

  • 00627755056948 ()

  • Width: 25 Inch
005XXCA-2XL

  • Surgical gown, reusable
Surgical Gown, Level 4, snaps at neck, tie waist, military neckband, Size 2XL
Lac-Mac Limited
005ABAL-2XL
In Commercial Distribution

  • 00627755056924 ()

  • Width: 25 Inch
005ABAL-2XL

  • Surgical gown, reusable
Surgical Gown, Level 4, snaps at neck, tie waist, military neckband, Size XL
Lac-Mac Limited
005XXCA-XL
In Commercial Distribution

  • 00627755055941 ()

  • Width: 25 Inch
005XXCA-XL

  • Surgical gown, reusable
Surgical Gown, Level 3, snaps at neck, tie waist, military neckband, Size XL
Lac-Mac Limited
005ABAL-XL
In Commercial Distribution

  • 00627755055927 ()

  • Width: 25 Inch
005ABAL-XL

  • Surgical gown, reusable
Surgical Gown, Level 4, snaps at neck, tie waist, military neckband, Size L
Lac-Mac Limited
005XXCA-L
In Commercial Distribution

  • 00627755054944 ()

  • Width: 25 Inch
005XXCA-L

  • Surgical gown, reusable
Surgical Gown, Level 3, snaps at neck, tie waist, military neckband, Size L
Lac-Mac Limited
005ABAL-L
In Commercial Distribution

  • 00627755054920 ()

  • Width: 25 Inch
005ABAL-L

  • Surgical gown, reusable
Surgical Gown, Level 4, snaps at neck, tie waist, military neckband, Size M
Lac-Mac Limited
005XXCA-M
In Commercial Distribution

  • 00627755053947 ()

  • Width: 25 Inch
005XXCA-M

  • Surgical gown, reusable
Surgical Gown, Level 3, snaps at neck, tie waist, military neckband, Size M
Lac-Mac Limited
005ABAL-M
In Commercial Distribution

  • 00627755053923 ()

  • Width: 25 Inch
005ABAL-M

  • Surgical gown, reusable
Surgical Gown, Level 4, snaps at neck, tie waist, military neckband, Size S
Lac-Mac Limited
005XXCA-S
In Commercial Distribution

  • 00627755052940 ()

  • Width: 25 Inch
005XXCA-S

  • Surgical gown, reusable
Surgical Gown, Level 3, snaps at neck, tie waist, military neckband, Size S
Lac-Mac Limited
005ABAL-S
In Commercial Distribution

  • 00627755052926 ()

  • Width: 25 Inch
005ABAL-S

  • Surgical gown, reusable
HATCHET 15L R-DOWN CUT, IN/OUT SHAPE, AT 10 O'CLOCK, for Duggan Institute
Power Dental U.S.A. Inc.
2319
In Commercial Distribution

  • D94323190 ()
2319

  • Dressing/utility forceps, scissors-like, reusable
  • Periodontal hoe
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