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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 Soft - 04019702511246

Elvarex Soft 1/Bermuda panty/with slip form on both sides/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
79579-00000-00
In Commercial Distribution

  • 04019702511246 ()

  • Pressure: 18-21 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex Soft - 04019702510669

Elvarex Soft 1/Capri-CT-Body Bandage/with slip form on both sides/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
79580-00000-00
In Commercial Distribution

  • 04019702510669 ()

  • Pressure: 18-21 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

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

Oxygen Kit - 00848530104528

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

Cover Gown - 00634916194173

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

MSI Precision Specialty Instruments - 00194613043018

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

MSI Precision Specialty Instruments - 00194613043001

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

MSI Precision Specialty Instruments - 00194613105860

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

MSI Precision Specialty Instruments - 00194613074739

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

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

Connexion - 04056719001261

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

Novo Surgical Inc. - 00842331129575

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

TrackX - 00857088008660

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

Quasar MD Blue - 00851478007080

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

CORTAC® - 00650551085508

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

CORTAC® - 00650551060932

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

CORTAC® - 00650551077404

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

CORTAC® - 00650551052838

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

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

Hayden Medical - 00840319707869

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

Hayden Medical - 00840319722695

Bodenhammer Rectal Speculum 6" (15.2cm) long, w/set screw, blades 3-1/2" (8.9cm) long x 3/4" (1.9cm) wide at distal end
Hayden Medical, Inc.
280-004
In Commercial Distribution

  • 00840319722695 ()
280-004

  • Rectal speculum

Ambler Surgical - 00190660051907

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

Ambler Surgical - 00190660028978

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

Ambler Surgical - 00190660076429

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

Ambler Surgical - 00190660104993

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

Ambler Surgical - 00190660156879

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

Quickie QX/QXi - 00016958053593

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

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

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
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