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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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ERA® Implant Abutment Micro 0°, 5mm Cuff (AT) - 00841549103520

ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812397
In Commercial Distribution

  • 00841549103520 ()


  • Dental implant suprastructure, permanent, preformed

ERA® Implant Abutment Micro 0°, 4mm Cuff (AT) - 00841549103513

ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812396
In Commercial Distribution

  • 00841549103513 ()


  • Dental implant suprastructure, permanent, preformed

ERA® Implant Abutment Micro 0°, 3mm Cuff (AT) - 00841549103506

ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812395
In Commercial Distribution

  • 00841549103506 ()


  • Dental implant suprastructure, permanent, preformed

ERA® Implant Abutment Micro 0°, 2mm Cuff (AT) - 00841549103490

ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812394
In Commercial Distribution

  • 00841549103490 ()


  • Dental implant suprastructure, permanent, preformed

ERA® Implant Abutment Micro 0°, 1mm Cuff (AT) - 00841549103483

ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812393
In Commercial Distribution

  • 00841549103483 ()


  • Dental implant suprastructure, permanent, preformed

New Fine Arts - Adults at Play - Silicone 2 oz - 00796494002971

Silicone-Based Personal Lubricant
CC Wellness LLC
72224
In Commercial Distribution

  • 10796494002978 ()
  • 00796494002971 ()


  • Sexual lubricant

New Fine Arts - Adults at Play - Hybrid 2 oz - 00796494002964

Hybrid Personal Lubricant
CC Wellness LLC
72222
In Commercial Distribution

  • 10796494002961 ()
  • 00796494002964 ()


  • Sexual lubricant

New Fine Arts - Adults at Play - Agape 2 oz - 00796494002957

Water-based Personal Lubricant
CC Wellness LLC
72221
In Commercial Distribution

  • 10796494002954 ()
  • 00796494002957 ()


  • Sexual lubricant

xCupTM - 10867802000273

The xCupTM for use with the xReaderTM is for in vitro diagnostic use and is intended for prescription use in laboratories, point-of-care and workplaces by trained users. The test is not intended for over-the-counter use. The test device cannot be read visually and must be used with the xReaderTM. The xCupTM qualitatively detects drug classes in human urine at the following cut-off concentrations: Amphetamines at 500 ng/ml; Barbiturates at 300 ng/mL; Benzodiazepines at 300 ng/mL; Cocaine at 150 ng/mL; Methamphetamines at 500 ng/mL; Methadone at 300 ng/mL; Morphine at 300 ng/mL and 2000 ng/mL; Oxycodone at 100 ng/mL; Phencyclidine at 25 ng/mL; and Marijuana at 50 ng/mL. Configurations of the xCupTM may consist of any combination of the listed drug analytes. The xCupTM only provides a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography / mass spectrometry (GC/MS), high performance liquid chromatography (HPLC) or liquid chromatography / tandem mass spectrometry (LC/MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
ESCREEN, INC.
DUE-1117X-071-01
In Commercial Distribution

  • 10867802000273 ()
  • 00867802000276 ()
DUE-1117X-071-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

ProMax Surgical Gown - 00634916819045

ProMax Surgical Gown, MLR Front Yoke with Kaumograph, Comfort Panel Back with Negastat, Color Coded Neck Binding, Snap Closures at Neck, Color Coded Tie Closures at Waist, With QCM, Circumferentially Offset Sleeves, Size 2XL
STANDARD TEXTILE CO., INC.
75615073
In Commercial Distribution

  • 10634916819042 ()
  • 00634916819045 ()


  • Surgical gown, reusable

NA - 04260491560025

Peripheral quantitative computed tomograph for the measurement at femur, radius or tibia. Evaluation of volumetric bone density, bone geometry and muscle parameter at the forarm, upper or lower leg using peripheral quantitative computes tomography.
Stratec Medizintechnik GmbH
XCT 3000
In Commercial Distribution

  • 04260491560025 ()
XCT 3000

  • Limited-view-field CT system

NA - 04260491560018

Peripheral quantitative computed tomograph for the measurement at femur, radius or tibia. Evaluation of volumetric bone density, bone geometry and muscle parameter at the forarm, upper or lower leg using peripheral quantitative computes tomography.
Stratec Medizintechnik GmbH
XCT 2000L
In Commercial Distribution

  • 04260491560018 ()
XCT 2000L

  • Limited-view-field CT system

MR PHACO - G412PH94701T0

Gimbel-Mendez Beveled Degree Gauge with teeth, 5 Degree Ruler markings on top of Unique bevel (labeled at 30 Degree increments), Mounted at 90 Degrees, Round Knurled Handle, 117mm Overall Length, Titanium (with Stainless color)
Crestpoint Management Limited
PH94071T
Not in Commercial Distribution

  • G412PH94701T0 ()


  • Medical ruler, reusable

MR PHACO - G412PH94071T0

Gimbel-Mendez Beveled Degree Gauge with teeth, 5 Degree Ruler markings on top of Unique bevel (labeled at 30 Degree increments), Mounted at 90 Degrees, Round Knurled Handle, 117mm Overall Length, Titanium (with Stainless color)
Crestpoint Management Limited
PH94071T
In Commercial Distribution

  • G412PH94071T0 ()


  • Medical ruler, reusable

Electronic Blood Pressure Monitor - 06972040110794

The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.
Shenzhen AOJ Medical Technology Co., Ltd
AOJ-35D
In Commercial Distribution

  • 06972040110794 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

NA - 30858512007021

Liquid Urine Control Dipstick - Negative/Positive, 20 ml. Contains 3 vials Negative and 3 vials Positive. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
301-12
In Commercial Distribution

  • 30858512007021 ()

  • Total Volume: 20 Milliliter
301-12

  • Multiple urine analyte IVD, control

Millennium - 00190776297503

5mm 45cm Endoclinch Fenestrated Grasper, 30deg angled shaft at distal end, designed for Single Site Trocars (Bend Begins at 12cm from Distal Tip), 3-piece modular take-apart, type 6 handle: lightweight carbon-fiber with RF post & ratchet
Avalign Technologies, Inc.
72-5215527C6SST
In Commercial Distribution

  • 00190776297503 ()


  • Rigid endoscopic tissue manipulation forceps, reusable

MR PHACO - G412PH6004T0

Crestpoint Mr. Phaco Mackool Maxicurve Big Ball Chopper (horizontal) DBL-Ended 0.6mm Mackool ball shaped tip with C-shaped curved shaft, Angled 10mm at 45* / Cylindrical Spatula, slightly vaulted 11.5mm at 50*, short round knurled handle, Titanium
Crestpoint Management Limited
PH6004T
In Commercial Distribution

  • G412PH6004T0 ()


  • Soft-tissue surgical hook, reusable

Osteotec CBG Ergonomic Torque Handle - 05060183095694

To be attached at the tube saw to provide the required torque to saw the bone.
OSTEOTEC LIMITED
OST-CBG-15
In Commercial Distribution

  • 05060183095694 ()
OST-CBG-15

  • Surgical instrument handle, non-torque-limiting

Lac-Mac - 00627755054043

Surgical Gown, Level 3, 3 sets grippers to knit neckband, ties at waist, patented Size L
Lac-Mac Limited
005XEAE-L
In Commercial Distribution

  • 00627755054043 ()

  • Height: 55.25 Inch
  • Width: 25 Inch
005XEAE-L

  • Surgical gown, reusable

Lac-Mac - 00627755054036

Surgical Gown, Level 4, 3 sets grips to knit neckband, tie at waist, patented Size L
Lac-Mac Limited
005XEAB-L
In Commercial Distribution

  • 00627755054036 ()

  • Height: 55.25 Inch
  • Width: 25 Inch
005XEAB-L

  • Surgical gown, reusable

Lac-Mac - 00627755053992

Surgical Gown, Level 3, 3 sets grippers to knit neckband, ties at waist, patented Size M
Lac-Mac Limited
005XFAO-M
In Commercial Distribution

  • 00627755053992 ()

  • Height: 54.25 Inch
005XFAO-M

  • Surgical gown, reusable

Lac-Mac - 00627755053954

Surgical Gown, Level 4, snaps at neck, tie waist, barrier to hem, military neckband, Size M
Lac-Mac Limited
005XXCB-M
In Commercial Distribution

  • 00627755053954 ()

  • Width: 25 Inch
005XXCB-M

  • Surgical gown, reusable

Lac-Mac - 00627755053930

Surgical Gown, Level 3, snaps at neck, tie waist, barrier to hem, military neckband, Size M
Lac-Mac Limited
005ABAM-M
In Commercial Distribution

  • 00627755053930 ()

  • Width: 25 Inch
005ABAM-M

  • Surgical gown, reusable

Lac-Mac - 00627755053046

Surgical Gown, Level 3, 3 sets grippers to knit neckband, ties at waist, patented Size M
Lac-Mac Limited
005XEAE-M
In Commercial Distribution

  • 00627755053046 ()

  • Height: 54.25 Inch
  • Width: 23 Inch
005XEAE-M

  • Surgical gown, reusable

Lac-Mac - 00627755053039

Surgical Gown, Level 4, 3 sets grips to knit neckband, tie at waist, patented Size M
Lac-Mac Limited
005XEAB-M
In Commercial Distribution

  • 00627755053039 ()

  • Height: 54.25 Inch
  • Width: 23 Inch
005XEAB-M

  • Surgical gown, reusable

Lac-Mac - 00627755052957

Surgical Gown, Level 4, snaps at neck, tie waist, barrier to hem, military neckband, Size S
Lac-Mac Limited
005XXCB-S
In Commercial Distribution

  • 00627755052957 ()

  • Width: 25 Inch
005XXCB-S

  • Surgical gown, reusable

Lac-Mac - 00627755052933

Surgical Gown, Level 3, snaps at neck, tie waist, barrier to hem, military neckband, Size S
Lac-Mac Limited
005ABAM-S
In Commercial Distribution

  • 00627755052933 ()

  • Width: 25 Inch
005ABAM-S

  • Surgical gown, reusable

Lac-Mac - 00627755052049

Surgical Gown, Level 3, 3 sets grippers to knit neckband, ties at waist, patented Size S
Lac-Mac Limited
005XEAE-S
In Commercial Distribution

  • 00627755052049 ()

  • Height: 53.25 Inch
  • Width: 21 Inch
005XEAE-S

  • Surgical gown, reusable

Lac-Mac - 00627755052032

Surgical Gown, Level 4, 3 sets grips to knit neckband, tie at waist, patented Size S
Lac-Mac Limited
005XEAB-S
In Commercial Distribution

  • 00627755052032 ()

  • Height: 53.25 Inch
  • Width: 21 Inch
005XEAB-S

  • Surgical gown, reusable

Lac-Mac - 00627755051035

Surgical Gown, Level 4, 3 sets grips to knit neckband, tie at waist, patented Size XS
Lac-Mac Limited
005XEAB-XS
In Commercial Distribution

  • 00627755051035 ()

  • Width: 19 Inch
  • Height: 51.25 Inch
005XEAB-XS

  • Surgical gown, reusable

Lac-Mac - 00627755591005

Surgical Gown, Level 4, 3 sets grips to knit neckband, tie at waist, patented Size 5XL
Lac-Mac Limited
005XFAH-5XL
In Commercial Distribution

  • 00627755591005 ()

  • Height: 57.25 Inch
005XFAH-5XL

  • Surgical gown, reusable

Lac-Mac - 00627755581013

Surgical Gown, Level 3, 3 sets grippers to knit neckband, ties at waist, patented Size 4XL
Lac-Mac Limited
005XFAP-4XL
In Commercial Distribution

  • 00627755581013 ()

  • Height: 58.25 Inch
005XFAP-4XL

  • Surgical gown, reusable

Lac-Mac - 00627755581006

Surgical Gown, Level 4, 3 sets grips to knit neckband, tie at waist, patented Size 4XL
Lac-Mac Limited
005XFAH-4XL
In Commercial Distribution

  • 00627755581006 ()

  • Height: 57.25 Inch
005XFAH-4XL

  • Surgical gown, reusable

Lac-Mac - 00627755571014

Surgical Gown, Level 3, 3 sets grippers to knit neckband, ties at waist, patented Size 3XL
Lac-Mac Limited
005XFAP-3XL
In Commercial Distribution

  • 00627755571014 ()

  • Height: 58.25 Inch
005XFAP-3XL

  • Surgical gown, reusable

Lac-Mac - 00627755571007

Surgical Gown, Level 4, 3 sets grips to knit neckband, tie at waist, patented Size 3XL
Lac-Mac Limited
005XFAH-3XL
In Commercial Distribution

  • 00627755571007 ()

  • Height: 57.25 Inch
005XFAH-3XL

  • Surgical gown, reusable

Lac-Mac - 00627755561015

Surgical Gown, Level 3, 3 sets grippers to knit neckband, ties at waist, patented Size 2XL
Lac-Mac Limited
005XFAP-2XL
In Commercial Distribution

  • 00627755561015 ()

  • Height: 57.25 Inch
005XFAP-2XL

  • Surgical gown, reusable

Lac-Mac - 00627755561008

Surgical Gown, Level 4, 3 sets grips to knit neckband, tie at waist, patented Size 2XL
Lac-Mac Limited
005XFAH-2XL
In Commercial Distribution

  • 00627755561008 ()

  • Height: 57.25 Inch
005XFAH-2XL

  • Surgical gown, reusable

Lac-Mac - 00627755551016

Surgical Gown, Level 3, 3 sets grippers to knit neckband, ties at waist, patented Size XL
Lac-Mac Limited
005XFAP-XL
In Commercial Distribution

  • 00627755551016 ()

  • Height: 56.25 Inch
005XFAP-XL

  • Surgical gown, reusable

Lac-Mac - 00627755551009

Surgical Gown, Level 4, 3 sets grips to knit neckband, tie at waist, patented Size XL
Lac-Mac Limited
005XFAH-XL
In Commercial Distribution

  • 00627755551009 ()

  • Height: 57.25 Inch
005XFAH-XL

  • Surgical gown, reusable

Lac-Mac - 00627755541017

Surgical Gown, Level 3, 3 sets grippers to knit neckband, ties at waist, patented Size L
Lac-Mac Limited
005XFAP-L
In Commercial Distribution

  • 00627755541017 ()

  • Height: 55.25 Inch
005XFAP-L

  • Surgical gown, reusable

Lac-Mac - 00627755541000

Surgical Gown, Level 4, 3 sets grips to knit neckband, tie at waist, patented Size L
Lac-Mac Limited
005XFAH-L
In Commercial Distribution

  • 00627755541000 ()

  • Height: 57.25 Inch
005XFAH-L

  • Surgical gown, reusable

Lac-Mac - 00627755531018

Surgical Gown, Level 3, 3 sets grippers to knit neckband, ties at waist, patented Size M
Lac-Mac Limited
005XFAP-M
In Commercial Distribution

  • 00627755531018 ()

  • Height: 54.25 Inch
005XFAP-M

  • Surgical gown, reusable

Lac-Mac - 00627755531001

Surgical Gown, Level 4, 3 sets grips to knit neckband, tie at waist, patented Size M
Lac-Mac Limited
005XFAH-M
In Commercial Distribution

  • 00627755531001 ()

  • Width: 57.25 Inch
005XFAH-M

  • Surgical gown, reusable

Lac-Mac - 00627755521019

Surgical Gown, Level 3, 3 sets grippers to knit neckband, ties at waist, patented Size S
Lac-Mac Limited
005XFAP-S
In Commercial Distribution

  • 00627755521019 ()

  • Height: 53.25 Inch
005XFAP-S

  • Surgical gown, reusable

Lac-Mac - 00627755511010

Surgical Gown, Level 3, 3 sets grippers to knit neckband, ties at waist, patented Size XS
Lac-Mac Limited
005XFAP-XS
In Commercial Distribution

  • 00627755511010 ()

  • Width: 19 Inch
005XFAP-XS

  • Surgical gown, reusable

Lac-Mac - 00627755058041

Surgical Gown, Level 3, 3 sets grippers to knit neckband, ties at waist, patented Size 4XL
Lac-Mac Limited
005XEAE-4XL
In Commercial Distribution

  • 00627755058041 ()

  • Height: 58.25 Inch
005XEAE-4XL

  • Surgical gown, reusable

Lac-Mac - 00627755057044

Surgical Gown, Level 3, 3 sets grippers to knit neckband, ties at waist, patented Size 3XL
Lac-Mac Limited
005XEAE-3XL
In Commercial Distribution

  • 00627755057044 ()

  • Height: 58.25 Inch
  • Width: 31 Inch
005XEAE-3XL

  • Surgical gown, reusable

Lac-Mac - 00627755057037

Surgical Gown, Level 4, 3 sets grips to knit neckband, tie at waist, patented Size 3XL
Lac-Mac Limited
005XEAB-3XL
In Commercial Distribution

  • 00627755057037 ()

  • Height: 58.25 Inch
  • Width: 31 Inch
005XEAB-3XL

  • Surgical gown, reusable

Lac-Mac - 00627755056955

Surgical Gown, Level 4, snaps at neck, tie waist, barrier to hem, military neckband, Size 2XL
Lac-Mac Limited
005XXCB-2XL
In Commercial Distribution

  • 00627755056955 ()

  • Width: 25 Inch
005XXCB-2XL

  • Surgical gown, reusable
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