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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140 mL Piston Syringe,Luer-Lock Tip
Cardinal Health, Inc.
8881114063
Not in Commercial Distribution

  • 10884521128910 ()
  • 20884521128917 ()

  • Total Volume: 140 Milliliter
  • Total Volume: 12 Milliliter
  • Total Volume: 20 Milliliter
  • Total Volume: 60 Milliliter
  • Total Volume: 6 Milliliter
  • Total Volume: 35 Milliliter
  • Total Volume: 3 Milliliter
  • Total Volume: 18 Gallon
8881114063

  • Irrigation syringe
No Description
Dynarex Corporation
6993BULK-LS
In Commercial Distribution

  • 00810180841948 ()
  • 00840117345157 ()


  • Irrigation syringe
No Description
Dynarex Corporation
6991BULK-LS
In Commercial Distribution

  • 00810180841931 ()
  • 00840117345140 ()


  • Irrigation syringe
0.9% Sodium Chloride,Flush Syringe, 5 mL Fill
Cardinal Health, Inc.
8881570125
Not in Commercial Distribution

  • 20884521005560 ()
  • 30884521005567 ()
  • 10884521005563 ()

  • Total Volume: 5 Milliliter
8881570125

  • Irrigation syringe
0.9% Sodium Chloride,Flush Syringe, 3 mL Fill
Cardinal Health, Inc.
8881570123
Not in Commercial Distribution

  • 20884521005553 ()
  • 30884521005550 ()
  • 10884521005556 ()

  • Total Volume: 3 Milliliter
8881570123

  • Irrigation syringe
The Short Indexing bar is required for accurate repositioning of accessories at the middle area of the Connexion™ Lateral Opening Module.
3C-Medical Intelligence GmbH
P10105-253
In Commercial Distribution

  • 04056719001261 ()
P10105-253

  • Accelerator system table, non-powered
mccabe flap knife dissector, double-ended, 2.0 mm x 3.0 mm blades angled at 25 degrees & 45 degrees, 7 1/4" (18.5 cm)
NOVO SURGICAL, INC.
E7315-91
In Commercial Distribution

  • 00842331129575 ()
E7315-91

  • Skin grafting knife
fischer tonsil knife & dissector, 15.0 mm curved blade w/ sharp edge at flat tip, top edge serrated, 8 1/2" (21.5 cm)
NOVO SURGICAL, INC.
E8331-81
In Commercial Distribution

  • 00842331140518 ()
E8331-81

  • Skin grafting knife
FIBER OPTIC DEEP PELVIC RETRACTOR WITH DOYAN HANDLE, OVERALL BLADE LENGTH 9" (228MM) X 2.5" (65MM) WIDE AT TOP, 2" (55MM) WIDE
ELMED INCORPORATED
15-09-70F
In Commercial Distribution

  • 00198506081866 ()
15-09-70F

  • Hand-held surgical retractor, reusable
  • Fibreoptic retractor handle
Ring Handle Micro Needle Holder 6" With Serrated Tungsten Carbide Inserts and The Jaw Tapers From 3mm to 1mm At The Tip
Med Saver, Inc.
38-3565BX
In Commercial Distribution

  • 00194613074739 ()


  • Suturing needle holder, reusable
Cottle Osteotome Curved 4mm Wide Cutting Edge With Centimeter Marking At 4cm / 5cm / 6cm and 7cm Overall Length 7 1/4" (184mm)
Med Saver, Inc.
114-5447
In Commercial Distribution

  • 00194613047726 ()


  • Orthopaedic osteotome
Cottle Osteotome Straight 12mm Wide Cutting Edge With Centimeter Marking At 4cm / 5cm / 6cm and 7cm Overall Length 7 1/4" (184mm)
Med Saver, Inc.
114-5453
In Commercial Distribution

  • 00194613043018 ()


  • Plastic surgery osteotome
Cottle Osteotome Straight 4mm Wide Cutting Edge With Centimeter Marking At 4cm / 5cm / 6cm and 7cm Overall Length 7 1/4" (184mm)
Med Saver, Inc.
114-5445
In Commercial Distribution

  • 00194613043001 ()


  • Plastic surgery osteotome
Grene Visual Axis Marker With Smooth And Flat Handle, 1.5mm Bend At Tip, And An Overall Length Of 4 1/2"" (115mm)
Med Saver, Inc.
11-4-9212
In Commercial Distribution

  • 00194613042073 ()


  • Corneal marker, reusable
Cottle Chisel Curved 6mm Wide Cutting Edge With Centimeter Marking At 4mm / 5mm / 6mm and 7mm Overall Length 7 1/4" (184mm)
Med Saver, Inc.
114-5456
In Commercial Distribution

  • 00194613060619 ()


  • Orthopaedic chisel
Day Ear Hook Medium 2.0mm Blunt Tip Angled At 90° On A Small Round Knurled Handle Overall Length 6 1/3" (159mm)
Med Saver, Inc.
114-1581-2
In Commercial Distribution

  • 00194613105860 ()


  • Soft-tissue surgical hook, reusable
COVER GOWN 100%C UNBLEACHED L W/Tie Closures at Neck and Self Waist Ties Raglan Long Sleeves w/Natural Poly Cuffs
STANDARD TEXTILE CO., INC.
74103400
Not in Commercial Distribution

  • 00634916194173 ()
  • 10634916194173 ()
74103400

  • Isolation gown, reusable
Atrium Health At Home O2 Kit This kit contains: (2) RES001, (1) RES012 , (2) RES018, (6) RES1107S, (2) RES3040G, and (1) RES003
SUNSET HEALTHCARE SOLUTIONS, INC.
ATRIUMO2KIT-10
In Commercial Distribution

  • 00848530104528 ()
  • 00848530104504 ()


  • Oxygen administration kit
SUBDURAL STRIP ELECTRODE, STAINLESS STEEL, 8 CONTACT, 1X8, RADIOPAQUE "L" AT CONTACT #1 & #8, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-08-093-NS
In Commercial Distribution

  • 00650551085508 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.76 Millimeter
2111-08-093-NS

  • Cortical electrode
This light therapy prescription-strength powerhouse banishes blemishes at their core with a larger treatment head bringing the dermatologist into your living room.
QUASAR BIO-TECH INC.
DPA-022
In Commercial Distribution

  • 00851478007080 ()
DPA-022

  • Blue/red/infrared phototherapy lamp
SUBDURAL GRID ELECTRODE, PLATINUM, 20 CONTACT, 4X5, SMOOTH, INLINE CONNECTOR, 2 EXITS, 2 LEADS, 2 TAILS, #1 CONTACT AT RIGHT CORNER NUMBERED
PMT CORPORATION
2110-20-046-NS
In Commercial Distribution

  • 00650551077404 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2110-20-046-NS

  • Cortical electrode
SUBDURAL GRID ELECTRODE, PLATINUM, 20 CONTACT, 4X5, SMOOTH, INLINE CONNECTOR, 2 EXITS, 2 LEADS, 2 TAILS, #1 CONTACT AT RIGHT CORNER NUMBERED
PMT CORPORATION
2110-20-046
In Commercial Distribution

  • 00650551052838 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2110-20-046

  • Cortical electrode
SUBDURAL STRIP ELECTRODE, STAINLESS STEEL, 8 CONTACT, 1X8, RADIOPAQUE "L" AT CONTACT #1 & #8, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-08-093
In Commercial Distribution

  • 00650551060932 ()

  • Thickness 0.76 Millimeter
  • Contact Diameter 3 Millimeter
2111-08-093

  • Cortical electrode
TrackX reusable adapter that enables physicians to more adequately utilize the Insight Base - NV/AT Disc Prep SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX NV INSERT-ADAPT
In Commercial Distribution

  • 00857088008660 ()
TX-3-4089

  • Diagnostic x-ray digital imaging system workstation application software
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
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
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
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
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
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
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
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
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
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
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
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
Pratt Rectal Speculum 8-1/2" (21.6cm) long, w/set screw, blades 3-1/2" (8.9cm) long x 1" (2.5cm) wide at distal end
Hayden Medical, Inc.
280-001
In Commercial Distribution

  • 00840319707869 ()
280-001

  • Rectal speculum
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
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
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
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
John ALK marker, 4 1/8'', 8 radial blades, 4 longer marks at 3, 6, 9, and 12 o'clock positions, flat handle
AMBLER SURGICAL CORP.
John ALK marker
In Commercial Distribution

  • 00190660104993 ()
8867E

  • Scleral marker, reusable
University of Kansas colibri corneal forceps, 4 1/4'', 0.12mm 2x2 teeth set at 45 degrees with 7.0mm tying platforms, flat handle
AMBLER SURGICAL CORP.
University of Kansas colibri corneal forceps
In Commercial Distribution

  • 00190660076429 ()
2336E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
The QUICKIE QXi is a durable, low-maintenance lightweight folding wheelchair that's perfect for the person looking for simplicity at the right price.
SUNRISE MEDICAL (US) LLC
QX/QXi
In Commercial Distribution

  • 00016958053593 ()
EIF6

  • Push-rim manual wheelchair, non-bariatric
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
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
Sideport/Groove economy diamond knife, straight, 1.00mm wide, 45 degrees single edge blade, dull sides, preset at 600 microns, j-slot aluminum handle
AMBLER SURGICAL CORP.
Sideport/Groove economy diamond knife
In Commercial Distribution

  • 00190660211912 ()
21-143E

  • Ophthalmic knife, reusable
Elvarex 3/Thigh High/Slant, Open Toe, E-Version, Knee Comfort/Thigh high slip form without volant to sew at body bandage/Black
BSN-Jobst GmbH
77567-01063-00
In Commercial Distribution

  • 04019702276152 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 3/Thigh High/Profile, Slant, Open Toe, E-Version, Knee Comfort/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77567-01024-00
In Commercial Distribution

  • 04019702275766 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 3/Thigh High/Slant, Closed Toe, E-Version, Knee Comfort/Thigh high slip form without volant to sew at body bandage/Black
BSN-Jobst GmbH
77567-01043-00
In Commercial Distribution

  • 04019702275575 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
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