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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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
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
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
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
RENASYS EDGE Carry Bag
SMITH & NEPHEW MEDICAL LIMITED
66803136
In Commercial Distribution

  • 05000223501136 ()
  • 05000223501129 ()

  • 172x135 x134W x H x Dmm (approximate dimensions with strap at longest)
66803136

  • Negative-pressure wound therapy system, electric, reusable
The Fenestration Punch is used for making small fenestrations in a Provox LaryTube at desired locations.
Atos Medical AB
7654
Not in Commercial Distribution

  • 07331791002632 ()
7654

  • Tracheostomy tube, non-reinforced, non-customized, reusable
OptiFix AT Absorbable Fixation System with Articulating Technology, 37 cm length, 5 mm diameter, 30 Fasteners
Davol Inc.
0113330
In Commercial Distribution

  • 10801741136563 ()
  • 00801741136566 ()

  • Length: 37 Centimeter
  • Outer Diameter: 5 Millimeter
0113330

  • Soft-tissue/mesh anchor, bioabsorbable
OptiFix AT Absorbable Fixation System with Articulating Technology, 37 cm length, 5 mm diameter, 15 Fasteners
Davol Inc.
0113315
In Commercial Distribution

  • 10801741136556 ()
  • 00801741136559 ()

  • Length: 37 Centimeter
  • Outer Diameter: 5 Millimeter
0113315

  • Soft-tissue/mesh anchor, bioabsorbable
Bishop-Harmon Cannula, 19 Gauge, Angled 30° at 5mm from bend to spatulated tip, 25mm tip length
Diamatrix
C191
In Commercial Distribution

  • 00813059017055 ()
C191

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Bishop-Harmon Cannula, 19 Gauge, Angled 35° at 7mm from bend to spatulated tip, 24mm tip length
Diamatrix
C190-19
In Commercial Distribution

  • 00813059014962 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
BODYMED LED MOIST AND DRY HEATING PAD, WITH AUTO SHUT-OFF AT 2 HOURS. 12" X 15"
BOXOUT, LLC
ZZHP1215EA
In Commercial Distribution

  • 20815991024195 ()
  • 00815991024191 ()


  • External electric-heating core temperature regulation system pad
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
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
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
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
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
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
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
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
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
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
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
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
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 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 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Surgical Gown, Level 3, snaps at neck, tie waist, barrier to hem, military neckband, Size 2XL
Lac-Mac Limited
005ABAM-2XL
In Commercial Distribution

  • 00627755056931 ()

  • Width: 25 Inch
005ABAM-2XL

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

  • 00627755056047 ()

  • Height: 57.25 Inch
  • Width: 29 Inch
005XEAE-2XL

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

  • 00627755056030 ()

  • Height: 57.25 Inch
  • Width: 29 Inch
005XEAB-2XL

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

  • 00627755055958 ()

  • Width: 25 Inch
005XXCB-XL

  • Surgical gown, reusable
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