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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Elvarex Soft 3/Capri-CT-Body Bandage/with slip form on both sides/Straight Top, slip form without Volant to sew at body bandage
BSN-Jobst GmbH
79575-00004-00
In Commercial Distribution

  • 04019702512427 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex Soft 3/Bermuda panty/with slip form on both sides/Straight Top, slip form without Volant to sew at body bandage
BSN-Jobst GmbH
79574-00004-00
In Commercial Distribution

  • 04019702512380 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex Soft 2/Capri-CT-Body Bandage/with slip form on both sides/Straight Top, slip form without Volant to sew at body bandage
BSN-Jobst GmbH
79573-00004-00
In Commercial Distribution

  • 04019702512342 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex Soft 2/Bermuda panty/with slip form on both sides/Straight Top, slip form without Volant to sew at body bandage
BSN-Jobst GmbH
79572-00004-00
In Commercial Distribution

  • 04019702512304 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
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
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
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
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
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
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
Colibri Forceps Standard .4mm 1x2 Teeth set at 45 Degree, 6mm Tying Platform, Oval Hole Flat Handle, 75mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH2394
In Commercial Distribution

  • G412PH23940 ()


  • Ophthalmic surgical device handling forceps, reusable
Colibri Forceps Standard .4mm 1x2 Teeth set at 45 Degree, without Tying Platform, Oval Hole Flat Handle, 75mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH2393
In Commercial Distribution

  • G412PH23930 ()


  • Ophthalmic surgical device handling forceps, reusable
Pierse-Colibri Corneal Forceps Very Delicate 1x1 Teeth set at 45 Degree, .1mm (.25mm hole), Oval Hole Flat Handle, 75mm Overall Length, Titanium
Crestpoint Management Limited
PH2391T
In Commercial Distribution

  • G412PH2391T0 ()


  • Ophthalmic surgical device handling forceps, reusable
Troutman-Barraquer Colibri Corneal Utility Forceps Very Delicate 1x2 Teeth set at 45 Degree with 6mm tying platform, .3mm, 73mm Overall Length, Titanium
Crestpoint Management Limited
PH2244T
In Commercial Distribution

  • G412PH2244T0 ()


  • Ophthalmic surgical device handling forceps, reusable
Colibri Forceps Very Delicate .12mm 1x2 Teeth, 2mm Angled tips set at 45 Degree with 6mm tying platform, 73mm Overall Length, Titanium
Crestpoint Management Limited
PH2243T
In Commercial Distribution

  • G412PH2243T0 ()


  • Ophthalmic surgical device handling forceps, reusable
Pierse-Colibri Corneal Forceps Very Delicate 1x1 Teeth set at 45 Degree, .1mm (.25mm hole), Serrated Flat Handle, 75mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH2241
In Commercial Distribution

  • G412PH22410 ()


  • Ophthalmic surgical device handling forceps, reusable
Osher Micro Suture .5mm J-Hook, Angled 12mm from bend to tip at 45 Degree, Round Knurled Handle, 116mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH1572
In Commercial Distribution

  • G412PH15720 ()


  • Soft-tissue surgical hook, reusable
Knolle-Pearce Irrigating Vectis 23gatw with 16ga Reinforced shaft, Three Outer Irrigating .3 ports at 12, 10, and 2 o'clock, 38mm Overall Length
Crestpoint Management Limited
CA770
In Commercial Distribution

  • G412CA7700 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Drews Posterior Capsule Polisher 25ga, Lightly angled, 2mm I.D. loop with textured posterior base, .2mm port at 6 o'clock, 23mm Overall Length
Crestpoint Management Limited
CA469
In Commercial Distribution

  • G412CA4690 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Anis Cortex Aspirating Cannula 23gatw Angled 35 Degree at 1.5mm from bend to tip, .4mm Port, without sandblasted finish, 26mm Overall Length
Crestpoint Management Limited
CA1443
In Commercial Distribution

  • G412CA14430 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, 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
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
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
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
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
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
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
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
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
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
TD-Web is a web solution to easily manage orders creation, optimize collection management and provide real-time results access at the patient’s bedside.
TECHNIDATA
TD-Web
In Commercial Distribution

  • 03770027519041 ()


  • Clinical laboratory information system application software
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
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
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
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
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
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 Transducer Support Holder provides a rigid, stable post for securing a transducer at the appropriate height for neuro and cardiac surgery.
STERIS CORPORATION
BF263
In Commercial Distribution

  • 00724995182236 ()
BF263

  • Universal operating table top
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 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
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
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
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
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