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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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JOBST Elvarex - 04019702256956

Elvarex 2/Thigh High/Slant, Closed Toe, E-Version, Knee Comfort/Thigh high slip form without volant to sew at body bandage/Black
BSN-Jobst GmbH
77556-01113-00
In Commercial Distribution

  • 04019702256956 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex - 04019702330342

Elvarex Forte 3/Thigh High/Slant, Closed Toe, E-Version, Knee Comfort/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77428-00421-00
In Commercial Distribution

  • 04019702330342 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex - 04019702330243

Elvarex Forte 3/Thigh High/Slant, Open Toe, E-Version, Knee Comfort/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77428-00431-00
In Commercial Distribution

  • 04019702330243 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex - 04019702300352

Elvarex 2/Leg Extension from below knee to thigh/Knee Comfort/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77338-00056-00
In Commercial Distribution

  • 04019702300352 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable

NA - 10858512007072

Liquid Urine Control for Microscopic and High Specific Gravity - Negative, 250 ml. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
301-4
In Commercial Distribution

  • 10858512007072 ()

  • Total Volume: 250 Milliliter
301-4

  • Multiple urine analyte IVD, control

Carnegie Surgical LLC - G141554333380

St Mark's Retractor BL 8 3/4", BW 2 1/2", BW at taper 1 3/4", 15 degree blade tip angle
Carnegie Surgical LLC
554-33338
In Commercial Distribution

  • G141554333380 ()
554-33338

  • Hand-held surgical retractor, reusable

ACTEON - 03609820877044

Circular scalpel angled at 130°, for osteoplasty, harvesting of bone particles or chips. Ridge osteoplasty, periodontal surgery, cysts exerisis, Alternative DI : 10887587009728
SATELEC
03.000.405S
In Commercial Distribution

  • 03609820877044 ()
F87704

  • Hard/soft-tissue ultrasonic surgical system

Rumex - 00840159906675

Holz Capsule Polisher, Angled Shaft, Texturized Bottom And Sharpened Ridge At The Top For Delicate Polishing, Length 120 mm, Round Titanium Handle
RUMEX INTERNATIONAL CORP.
7-142
In Commercial Distribution

  • 00840159906675 ()
7-142

  • General-purpose surgical spatula

Resp-O2 Heat Moisture Exchanger (HME) 1250 Tracheostomy - 00840117305533

T-Shape, Suction Port, Adult, Tidal Volume Range(150-1250mL), Media(Foam),Dead Space(15mL), Breathing Resistance(0.2cm H2O at 30L/min), Weight(5.5g)
Dynarex Corporation
30301
In Commercial Distribution

  • 00840117305533 ()
  • 00840117305540 ()


  • Heat/moisture exchanger/microbial medical gas filter

Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500 B/V Filter and CO2 Port - 00840117305335

Adult, Tidal Volume Range(250-1500 mL), Media (Foam + Flat Media), Dead Space (60mL), Breathing Resistance (1.8cm H2O at 60L /min), Weight (36g)
Dynarex Corporation
30105
In Commercial Distribution

  • 00840117305342 ()
  • 00840117305335 ()


  • Heat/moisture exchanger/microbial medical gas filter

HYGITECH - 03615140003247

Standard protection: • It holds back loose hair from the face • There are 2 ties at the back to secure the cap firmly
HYGITECH
HY-50013
In Commercial Distribution

  • 03615140003254 ()
  • 03615140003247 ()
HY-50013

  • Medical equipment/instrument drape, single-use

V. Mueller - 10885403098109

V. Mueller BONACCOLTO UTILITY and PICK-UP FCPS, SMALL 1.2MM WIDE AT TIPS TIPS HAVE FINE CROSS-SERRATION OVERALL LENGTH 3-7/8 inches 9.8CM
STERIS CORPORATION
OP3183
In Commercial Distribution

  • 10885403098109 ()
OP3183

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

JOBST Elvarex - 04019702451610

Elvarex 2/Thigh High/Slant, Open Toe, E-Version, Knee Comfort/Thigh high slip form without volant to sew at body bandage/Navy
BSN-Jobst GmbH
77556-01877-00
In Commercial Distribution

  • 04019702451610 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex - 04019702403763

Elvarex 2/Thigh High/Slant, Closed Toe, E-Version, Knee Comfort/Thigh high slip form without volant to sew at body bandage/Cocoa
BSN-Jobst GmbH
77556-02457-00
In Commercial Distribution

  • 04019702403763 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex - 04019702401523

Elvarex 2/Thigh High/Slant, Open Toe, E-Version, Knee Comfort/Thigh high slip form without volant to sew at body bandage/Cocoa
BSN-Jobst GmbH
77556-02467-00
In Commercial Distribution

  • 04019702401523 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex - 04019702346466

Elvarex 3/Leg Extension from below knee to thigh/Knee Comfort/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77381-00042-00
In Commercial Distribution

  • 04019702346466 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable

Ambler Surgical - 00190660001971

McCabe measuring instrument, 6 7/8'', straight shaft, slightly curved tip, rings at 3.0mm, 4.0mm and 5.0mm from distal tip, round handle
AMBLER SURGICAL CORP.
McCabe measuring instrument
In Commercial Distribution

  • 00190660001971 ()
14-155

  • Fistula probe

Ambler Surgical - 00190660197087

Micro toothed forceps, 3 7/8'', straight shafts with 0.10mm 1x2 teeth set at 60 degrees, 4mm tying platforms, flat knurled handle
AMBLER SURGICAL CORP.
Micro toothed forceps
In Commercial Distribution

  • 00190660197087 ()
M5220

  • Dressing/utility forceps, scissors-like, reusable

Ambler Surgical - 00190660197070

Micro toothed forceps, 3 3/4'', straight shafts with 0.063mm 1x2 teeth set at 60 degrees, 4mm tying platforms, flat knurled handle
AMBLER SURGICAL CORP.
Micro toothed forceps
In Commercial Distribution

  • 00190660197070 ()
M5210

  • Dressing/utility forceps, scissors-like, reusable

Resp-O2 Heat Moisture Exchanger (HME) 1500 Tracheostomy - 00840117318137

Bow Tie,Adult : Tidal Volume Range(75-1500mL), Media(Corrugated Paper), Dead Space(12mL), Breathing Resistance(0.2cm H2O at 30L/min), Weight(4.8g)
Dynarex Corporation
30305
In Commercial Distribution

  • 00840117318120 ()
  • 00840117318137 ()


  • Heat/moisture exchanger, single-use

Novo Surgical - G586OP7121040

knolle lens nucleus spatula & gauge, 30 mm blade, with marking at 5 mm, 6 mm & 7 mm from tip, 5" (12.7 cm)
NOVO SURGICAL, INC.
OP7121-04
In Commercial Distribution

  • G586OP7121040 ()
OP7121-04

  • Ophthalmic surgical probe, reusable

Surgical Direct - B382S340162000

Henderson Style Pre-Op Reference Marker, Half Circle With 3 Blunt Alignment Pins At 0, 90 and 180 Degrees, With Round Knurled Handle
Surgical Direct, Inc.
S34016.200
In Commercial Distribution

  • B382S340162000 ()
S34016.200

  • Intraocular retractor, reusable

Ventricular Catheter - 10381780033332

20 cm Radiopaque Straight Ventricular Catheter with large holes and graphite based length marks at 5, 10, 15 cm from the tip.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
901302
Not in Commercial Distribution

  • 10381780033332 ()
  • M2729013021 ()

  • Vent. Cath. 20cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Introducer 22cm Length
901302

  • Intracerebral infusion/drainage catheter, short-term

Titan - 00817914023755

M-Style Bayonet Bipolar Forcep 7 3/4" (196.85mm) Irrigating and Insulated With A With A 0.25mm Tip (*** PRODUCT MAY SCISSOR AT TIPS ***)
TITAN MANUFACTURING INC
263318239010101
In Commercial Distribution

  • 00817914023755 ()

  • Length: 7.75 Inch


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Titan - 00817914023731

M-Style Straight Bipolar Forcep 5" (127mm) Insulated And Irrigating With A With A Straight 0.25mm Tip Anti-Stick (*** PRODUCT MAY SCISSOR AT TIPS ***)
TITAN MANUFACTURING INC
263228217010101
In Commercial Distribution

  • 00817914023731 ()

  • Length: 5 Inch


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Titan - 00817914023403

Scoville-Greenwood Bayonet Bipolar Forcep 7 3/4" (196.85mm) Irrigating And Insulated With A With A 0.25mm Tip (*** PRODUCT MAY SCISSOR AT TIPS ***)
TITAN MANUFACTURING INC
262018239010101
In Commercial Distribution

  • 00817914023403 ()

  • Length: 196.85 Millimeter


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Titan - 00817914021300

M-Style Straight Bipolar Forcep 6 3/4" (171.45mm) Insulated With A With A 0.2mm Tip With Stop (*** PRODUCT MAY SCISSOR AT TIPS ***)
TITAN MANUFACTURING INC
163218131000101
In Commercial Distribution

  • 00817914021300 ()

  • Length: 171.45 Millimeter


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Pointe Scientific - 00811727012555

AST Reagent Set for the quantitative determination of Aspartate Aminotransferase (AST) in human serum. Packaged at 5 x 100ml, 2 x 55ml
POINTE SCIENTIFIC, INC.
HA961-610
In Commercial Distribution

  • 00811727012555 ()
HA961-610

  • Aspartate aminotransferase (AST) isoenzyme IVD, reagent

K-ASSAY® Multi-Analyte Calibrator - 00816426020566

For the calibration of the K-ASSAY® Alpha-1 AG, Alpha-1 AT, Complement C3, Comlement C4, Haptoglobin, IgA, IgG, IgM, and Transferrin assays.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-016C
In Commercial Distribution

  • 00816426020566 ()
KAI-016C

  • Plasma protein IVD, calibrator

Diamatrix - 00813059017444

Gimbel Nucleus Spatula, .25mm Diameter, Angled 10mm from bend to tip at 30°, Smooth, Round knurled Handle, 109mm total length, Stainless Steel
Diamatrix
H308-S
In Commercial Distribution

  • 00813059017444 ()
H308-S

  • Ocular hook/spatula/manipulator, reusable

Diamatrix - 00813059017437

Bechert-McPherson Tying Forceps, Angled 10.5mm from bend to tip at 45°, 10mm smooth tying platform, Flat serrated handle, 84mm total length, Stainless
Diamatrix
F805S
In Commercial Distribution

  • 00813059017437 ()
F805S

  • Suturing needle holder, reusable

Poly Pro - B3437000A2

LED Light Therapy Device. Uses 1820 LEDs at 633nm to treat facial wrinkles. Available for use in Salons, Spas, Med Spas, Dermatology.
Medtek Lighting Corporation
Poly Pro Rejuv
In Commercial Distribution

  • B3437000A2 ()


  • Blue/red/infrared phototherapy lamp

Nella NuSpec - 00860000270427

Reusable Vaginal Speculum
CEEK WOMEN'S HEALTH
NU001
In Commercial Distribution

  • 10860000270424 ()
  • 00860000270427 ()


  • Vaginal speculum, reusable

Realstar Surgical - 00860012999699

Vu-Max (Pederson), Large
REAL STAR SURGICAL INSTRUMENTS
RSSI-130-114
In Commercial Distribution

  • 00860012999699 ()


  • Vaginal speculum, reusable

Realstar Surgical - 00860012999682

Vu-Max (Pederson) , Medium
REAL STAR SURGICAL INSTRUMENTS
RSSI-130-115
In Commercial Distribution

  • 00860012999682 ()


  • Vaginal speculum, reusable

Realstar Surgical - 00860012999675

Pederson Vaginal Speculum, Large
REAL STAR SURGICAL INSTRUMENTS
RSSI-130-200
In Commercial Distribution

  • 00860012999675 ()


  • Vaginal speculum, reusable

Realstar Sugical - 00860012999668

Pederson Vaginal Speculum, Medium
REAL STAR SURGICAL INSTRUMENTS
RSSI-130-202
In Commercial Distribution

  • 00860012999668 ()


  • Vaginal speculum, reusable

Realstar Surgical - 00860012999651

Pederson Vaginal Speculum, Small
REAL STAR SURGICAL INSTRUMENTS
RSSI-130-203
In Commercial Distribution

  • 00860012999651 ()


  • Vaginal speculum, reusable

Realstar Surgical - 00860012999644

Graves Vaginal Speculum, X-Large
REAL STAR SURGICAL INSTRUMENTS
RSSI-130-104
In Commercial Distribution

  • 00860012999644 ()


  • Vaginal speculum, reusable

Realstar Surgical - 00860012999637

Graves Vaginal Speculum, Small
REAL STAR SURGICAL INSTRUMENTS
RSSI-130-103
In Commercial Distribution

  • 00860012999637 ()


  • Vaginal speculum, reusable
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