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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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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
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
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
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
Azar corneal scissors, 4 1/2'', universal medium model, curved 16.0mm blades, blunt tips, calibration markings at 1 to 6.0mm, flat handle
AMBLER SURGICAL CORP.
Azar corneal scissors
In Commercial Distribution

  • 00190660156879 ()
5847E

  • Corneal scissors, reusable
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
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
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
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
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
Dyson colibri forceps, 2 7/8'', very delicate, thin shanks, 0.12mm 1x2 teeth set at 45 degrees, with tying platform, flat handle
AMBLER SURGICAL CORP.
Dyson colibri forceps
In Commercial Distribution

  • 00190660051907 ()
9508E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
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
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
Micro toothed forceps, 2 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

  • 00190660197025 ()
M5120

  • Dressing/utility forceps, scissors-like, reusable
Micro toothed forceps, 2 7/8'', 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

  • 00190660197018 ()
M5110

  • Dressing/utility forceps, scissors-like, reusable
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
Castroviejo colibri corneal forceps, 4 1/4'', 0.12mm 1x2 teeth set at 45 degrees, 6.0mm TC dusted tying platforms, wide flat handle
AMBLER SURGICAL CORP.
Castroviejo colibri corneal forceps
In Commercial Distribution

  • 00190660042905 ()
2234E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Bonn suturing forceps, 4 1/4'', straight shafts, 0.12mm 1x2 teeth set at 90 degrees, 5.0mm tying platforms, ergonomic fenestrated round handle
AMBLER SURGICAL CORP.
Bonn suturing forceps
In Commercial Distribution

  • 00190660041847 ()
2352E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
LRI economy diamond knife, straight, 1.00mm wide, 30 degrees lance blade, dull sides, single footplate, preset at 600 microns, j-slot aluminum handle
AMBLER SURGICAL CORP.
LRI economy diamond knife
In Commercial Distribution

  • 00190660028978 ()
21-232E

  • Ophthalmic knife, reusable
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
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
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
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
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
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
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
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
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
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