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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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PRO-FUSE® - 00884908149005

8F PLASTIC Pro-Fuse® CT PORT W/ATTACHABLECT PORT W/AT ChronoFlex®POLYURETHANE CATHETERCATHETER
Medical Components, Inc.
MRCTT80001OR
Not in Commercial Distribution

  • 50884908149000 ()
  • 00884908149005 ()
MRCTT80001OR

  • Vascular port/catheter

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

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

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 - 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

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

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

.decimal Electron Aperture - 00851147007038

A custom made device that shapes and focuses the electron beam aimed at the cancerous tissue.
DECIMAL, INC.
1.0
In Commercial Distribution

  • 00851147007038 ()


  • Radiation therapy beam block material

Baby Blue Pink - 00851478007059

This light therapy beauty tool attacks blemishes at its core without the need for oral medications
QUASAR BIO-TECH INC.
DPA-002-PK
In Commercial Distribution

  • 00851478007059 ()
DPA-002-PK

  • Blue/red/infrared phototherapy lamp

Baby Blue - 00851478007042

This light therapy beauty tool attacks blemishes at its core without the need for oral medications
QUASAR BIO-TECH INC.
DPA-002
In Commercial Distribution

  • 00851478007042 ()
DPA-002

  • Blue/red/infrared phototherapy lamp

Proov - 00850035206058

At home IVD FSH test to measure follicle stimulating hormone and check your ovarian reserve status.
Mfb Fertility, Inc.
Reserve
In Commercial Distribution

  • 00850035206058 ()


  • Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing

Li-ion Battery charger - 04547410180220

A battery charger for the battery pack. Three packs can be charged at the same time.
FUJIFILM CORPORATION
DR601 SE BATTERY CHARGER E
In Commercial Distribution

  • 04547410180220 ()


  • Stationary basic diagnostic x-ray system, digital

HNM MEDICAL - 00842962161807

SIZE 2, 0 WT/B FORCEBRAID 20", UHMWPE NO, AB SURGICAL SUTURE W/AT, 2 NEEDLE
HNM STAINLESS, LLC.
HNM-VAL2020WBN
In Commercial Distribution

  • 00842962161807 ()
HNM-VAL2020WBN

  • Suturing unit, reusable

V. Mueller - 10885403096303

V. Mueller NAGAHARA NUCLEUS CHOPPER, RIGHT, 1.25MM TIP, BLADE OFFSET AT 60DEG ANGLE, ROUND, KNURLED HANDLE
STERIS CORPORATION
OP0925-602
In Commercial Distribution

  • 10885403096303 ()
OP0925602

  • Ophthalmic surgical probe, reusable

V. Mueller - 10885403096297

V. Mueller NAGAHARA NUCLEUS CHOPPER, LEFT, 1.25MM TIP, BLADE OFFSET AT 60DEG ANGLE, ROUND, KNURLED HANDLE
STERIS CORPORATION
OP0925-601
In Commercial Distribution

  • 10885403096297 ()
OP0925601

  • Ophthalmic surgical probe, reusable

V. Mueller - 10885403092749

V. Mueller KRAFF CAPSULE TAG FORCEPS 1.5MM SMOOTH PLATFORM AT TIPS 11MM JAWS, FLAT FENESTRATED HANDLE.
STERIS CORPORATION
OP0911-901
In Commercial Distribution

  • 10885403092749 ()
OP0911901

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Ambler Surgical - 00190660076146

Troutman-Barraquer colibri corneal forceps, 2 7/8'', 0.5mm 1x2 teeth set at 45 degrees, flat handle
AMBLER SURGICAL CORP.
Troutman-Barraquer colibri corneal forceps
In Commercial Distribution

  • 00190660076146 ()
2228E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Ambler Surgical - 00190660076092

Troutman-Barraquer colibri corneal forceps, 2 7/8'', 0.12mm 1x2 teeth set at 45 degrees, flat handle
AMBLER SURGICAL CORP.
Troutman-Barraquer colibri corneal forceps
In Commercial Distribution

  • 00190660076092 ()
2240E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Ambler Surgical - 00190660039172

Ambler colibri forceps, 3'', very delicate, 0.12mm 1x2 teeth set at 90 degrees, without tying platform
AMBLER SURGICAL CORP.
Ambler colibri forceps
In Commercial Distribution

  • 00190660039172 ()
9541E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Ambler Surgical - 00190660039165

Ambler colibri forceps, 3'', very delicate, 0.12mm 1x2 teeth set at 90 degrees, flat handle, titanium
AMBLER SURGICAL CORP.
Ambler colibri forceps
In Commercial Distribution

  • 00190660039165 ()
9507T

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Hayden Medical - 00840319739723

Potts-Smith Dressing Forceps 9-1/2" (23.8cm), serrated, NON-CONDUCTIVE, bent proximal to tip, exposed at both ends
Hayden Medical, Inc.
120-158BNC
In Commercial Distribution

  • 00840319739723 ()
120-158BNC

  • Dressing/utility forceps, tweezers-like, reusable

Ambler Surgical - 00190660185749

Peck suction tube, 7 1/2'', 4.0mm diameter, calibrated at 5cm, 6cm, 7cm, 8cm and 9cm
AMBLER SURGICAL CORP.
Peck suction tube
In Commercial Distribution

  • 00190660185749 ()
89-700

  • Surgical/emergency suction cannula, non-illuminating, reusable

Ambler Surgical - 00190660155933

Helveston scleral ruler, 6'', vaulted, notches in 5.0mm increments, single marking tooth at tip, flat handle
AMBLER SURGICAL CORP.
Helveston scleral ruler
In Commercial Distribution

  • 00190660155933 ()
1112E

  • General-purpose calliper, metallic

JOBST Elvarex - 04019702336016

Elvarex 3/Mid Thigh High/Slant-Open Toe/Thigh high without volant to sew at body bandage
BSN-Jobst GmbH
77372-00063-00
In Commercial Distribution

  • 04019702336016 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex - 04019702335118

Elvarex 3/Mid Thigh High/Slant-Closed Toe/Thigh high without volant to sew at body bandage
BSN-Jobst GmbH
77372-00075-00
In Commercial Distribution

  • 04019702335118 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex - 04019702329568

Elvarex Forte 3/Thigh High/Slant-Open Toe-Elephantiasis-Version/Thigh high without volant to sew at body bandage
BSN-Jobst GmbH
77428-00176-00
In Commercial Distribution

  • 04019702329568 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex - 04019702295290

Elvarex 2/Mid Thigh High/Profile-Slant-Open Toe/Thigh high without volant to sew at body bandage
BSN-Jobst GmbH
77340-00070-00
In Commercial Distribution

  • 04019702295290 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex - 04019702294972

Elvarex 2/Mid Thigh High/Slant-Open Toe-Elephantiasis-Version/Thigh high without volant to sew at body bandage
BSN-Jobst GmbH
77340-00092-00
In Commercial Distribution

  • 04019702294972 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex - 04019702292404

Elvarex 3/Thigh High/Closed Toe/Thigh high without volant to sew at body bandage/Black
BSN-Jobst GmbH
77567-00241-00
In Commercial Distribution

  • 04019702292404 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable

MR PHACO - G412CA16290

Provisc Irrigation Cannula 27ga, Angled 8mm from bend to tip at 30 Degree, 22mm Overall Length
Crestpoint Management Limited
CA1629
In Commercial Distribution

  • G412CA16290 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

Novo Surgical - G586E748686R0

peck suction cannula, 4.0 mm, calibrations marked at 5.0 - 9.0 cm, 7 1/2" (19.0 cm)
NOVO SURGICAL, INC.
E7486-86R
In Commercial Distribution

  • G586E748686R0 ()
E7486-86R

  • Surgical/emergency suction cannula, non-illuminating, 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

Novo Surgical - 00842331123252

Cooley Pediatric Clamp, delicate clamp, jaws calibrated at 5.0 mm intervals, 5-1/2" (14.0 cm), satinsky
NOVO SURGICAL, INC.
C6661-14
In Commercial Distribution

  • 00842331123252 ()

  • Length: 14 Centimeter


  • Surgical A/V-shaped microvessel clamp

Novo Surgical - 00842331115776

Cooley Pediatric Clamp, delicate clamp, jaws calibrated at 5.0 mm intervals, 5-1/2" (14.0 cm), satinsky
NOVO SURGICAL, INC.
5550-03
Not in Commercial Distribution

  • 00842331115776 ()

  • Length: 14 Centimeter
5550-03

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable

ELMED INCORPORATED - 00198506064005

Fansler proctoscope. Open at top. 1-1/3" (3.3cm) Diameter. Mirror finish. Working length 2-3/8in (6cm).
ELMED INCORPORATED
ST6922629
In Commercial Distribution

  • 00198506064005 ()
ST6922629

  • Optical anoscope, reusable

ELMED - 00198506057540

Fansler proctoscope. Open at top. 1-1/3" (3.3cm) Diameter. Mirror finish. Working length 2-3/8in (6cm).
ELMED INCORPORATED
EL-SU220
In Commercial Distribution

  • 00198506057540 ()
EL-SU220

  • Optical anoscope, 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
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