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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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Elvarex Soft 1/AT-Body Bandage/Closed Toe-Both Sides-Slip/Thigh high slip form without volant to sew at body bandage/Black
BSN-Jobst GmbH
79578-00009-00
In Commercial Distribution

  • 04019702511017 ()

  • Pressure: 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex Soft 1/AT-Body Bandage/Slant-Open Toe-Both Sides-Slip-Waist Band/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
79578-00006-00
In Commercial Distribution

  • 04019702510980 ()

  • Pressure: 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex Soft 1/AT-Body Bandage/Open Toe-Both Sides-Slip-Waist Band/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
79578-00002-00
In Commercial Distribution

  • 04019702510942 ()

  • Pressure: 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
COVERALL, DISPOSABLE, WHITE, 3XLARGE, ELASTIC CUFF, OPEN ANKLE, BACK ELASTIC AT LUMBAR, SMS 35GSM, 5EA/BG, 10BG/CS (50EA/CS)
Asp Global, LLC
GNTW505
In Commercial Distribution

  • 00840216106697 ()


  • Surgical coverall
COVERALL, DISPOSABLE, WHITE, 2XLARGE, ELASTIC CUFF, OPEN ANKLE, BACK ELASTIC AT LUMBAR, SMS 35GSM, 5EA/BG, 10BG/CS (50EA/CS)
Asp Global, LLC
GNTW504
In Commercial Distribution

  • 00840216106680 ()


  • Surgical coverall
COVERALL, DISPOSABLE, WHITE, XLARGE, ELASTIC CUFF, OPEN ANKLE, BACK ELASTIC AT LUMBAR, SMS 35GSM, 5EA/BG, 10BG/CS (50EA/CS)
Asp Global, LLC
GNTW503
In Commercial Distribution

  • 00840216106673 ()


  • Surgical coverall
Cottle osteotome, 7 1/4'', straight, 9.0mm wide, with markings at 4.0cm, 5.0cm, 6.0cm and 7.0cm, rounded corners, flat handle
AMBLER SURGICAL CORP.
Cottle osteotome
In Commercial Distribution

  • 00190660122744 ()
59-354

  • Plastic surgery osteotome
Cottle osteotome, 7 1/4'', straight, 6.0mm wide, with markings at 4.0cm, 5.0cm, 6.0cm and 7.0cm, rounded corners, flat handle
AMBLER SURGICAL CORP.
Cottle osteotome
In Commercial Distribution

  • 00190660122737 ()
59-352

  • Plastic surgery osteotome
Cottle osteotome, 7 1/4'', straight, 4.0mm wide, with markings at 4.0cm, 5.0cm, 6.0cm and 7.0cm, rounded corners, flat handle
AMBLER SURGICAL CORP.
Cottle osteotome
In Commercial Distribution

  • 00190660122720 ()
59-350

  • Plastic surgery osteotome
Cottle osteotome, 7 1/4'', straight, 20.0mm wide, with markings at 4.0cm, 5.0cm, 6.0cm and 7.0cm, rounded corners, flat handle
AMBLER SURGICAL CORP.
Cottle osteotome
In Commercial Distribution

  • 00190660122713 ()
59-360

  • Plastic surgery osteotome
Cottle osteotome, 7 1/4'', straight, 14.0mm wide, with markings at 4.0cm, 5.0cm, 6.0cm and 7.0cm, rounded corners, flat handle
AMBLER SURGICAL CORP.
Cottle osteotome
In Commercial Distribution

  • 00190660122706 ()
59-358

  • Plastic surgery osteotome
Cottle osteotome, 7 1/4'', straight, 12.0mm wide, with markings at 4.0cm, 5.0cm, 6.0cm and 7.0cm, rounded corners, flat handle
AMBLER SURGICAL CORP.
Cottle osteotome
In Commercial Distribution

  • 00190660122690 ()
59-356

  • Plastic surgery osteotome
Cottle osteotome, 7 1/4'', curved, 6.0mm wide, with markings at 4.0cm, 5.0cm, 6.0cm and 7.0cm, rounded corners, flat handle
AMBLER SURGICAL CORP.
Cottle osteotome
In Commercial Distribution

  • 00190660122683 ()
59-353

  • Nasal chisel
Cottle osteotome, 7 1/4'', curved, 4.0mm wide, with markings at 4.0cm, 5.0cm, 6.0cm and 7.0cm, rounded corners, flat handle
AMBLER SURGICAL CORP.
Cottle osteotome
In Commercial Distribution

  • 00190660122676 ()
59-351

  • Nasal chisel
LRI economy diamond knife, straight, 1.00mm wide, tri-square blade, sharp sides, single footplate, preset at 600 microns, j-slot aluminum handle
AMBLER SURGICAL CORP.
LRI economy diamond knife
In Commercial Distribution

  • 00190660218850 ()
27-653E

  • Ophthalmic knife, reusable
Tidal Volume Range(150-1500mL) Media(Foam), Dead Space(34mL), Breathing Resistance(2.8cm H2O at 60 L/min), Weight(15g), Adult
Dynarex Corporation
30203
In Commercial Distribution

  • 00840117305441 ()
  • 00840117305434 ()


  • Heat/moisture exchanger/microbial medical gas filter
Chaya Double Ended Chopper, Triple Edged Chopper With Polisher Tip (Verges Style)/Modified Axe Chopper, Offset at 90 Degree, LHD
AURORA SURGICAL, LLC
AS9-052L
In Commercial Distribution

  • 08175700138727 ()
AS9-052L

  • Ophthalmic surgical probe, reusable
Chaya Double Ended Chopper, Triple Edged Chopper With Polisher Tip (Verges Style)/Modified Axe Chopper, Offset at 90 Degree, RHD
AURORA SURGICAL, LLC
AS9-052R
In Commercial Distribution

  • 08175700137973 ()
AS9-052R

  • Ophthalmic surgical probe, reusable
Integra® Miltex® Sims Rectal Speculum, 6", Fenestrated Blades, 3-1/2" Deep x 5/8" Wide At Distal End
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
MH28-2
In Commercial Distribution

  • H834MH2820 ()
  • 10381780488088 ()
MH28-2

  • Rectal speculum
Fogla Fine-Pointed Dissector, Angled 60 Degree at 5mm from bend to tip, Round Knurled Handle, 114mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH6606
In Commercial Distribution

  • G412PH66060 ()


  • Soft-tissue surgical hook, reusable
TTI-McPherson Tying Forceps Angled 10.5mm at 45 Degree, with 10mm Smooth Tying Platform, Round Knurled Handle, 105mm Overall Length, Titanium
Crestpoint Management Limited
PH2443T
In Commercial Distribution

  • G412PH2443T0 ()


  • Ophthalmic surgical device handling forceps, reusable
Bechert-McPherson Tying Forceps Angled 10.5mm at 45 Degree, with 10mm Smooth Tying Platform, Serrated Flat Handle, 84mm Overall Length, Titanium
Crestpoint Management Limited
PH2032T
In Commercial Distribution

  • G412PH2032T0 ()


  • Ophthalmic surgical device handling forceps, reusable
Colibri Utility Forceps Very Delicate 1x2 Teeth set at 45 Degree, .12mm, Oval Hole Flat Handle, 75mm Overall Length, Titanium
Crestpoint Management Limited
PH1028T
In Commercial Distribution

  • G412PH1028T0 ()


  • Ophthalmic surgical device handling forceps, reusable
Seeley Hydrodissection Cannula 26ga, Angled 12mm from bend to tip at 45 Degree, Flattened 2mm Horizontal Tip, 12mm Overall Length
Crestpoint Management Limited
CA436
In Commercial Distribution

  • G412CA4360 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Healon/Viscoelastic Injection Cannula 21ga, Flattened Round Tip, Angled 5mm from bend to tip at 40 degree, 29mm Overall Length
Crestpoint Management Limited
CA320
In Commercial Distribution

  • G412CA3200 ()


  • 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, 26mm Overall Length, Sandblasted
Crestpoint Management Limited
CA292
In Commercial Distribution

  • G412CA2920 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Buratto Hydrodissectional Cannula 25ga Flattened .6mm tip, Angled/Vaulted 14mm from bend to tip at 50 Degrees, 18mm Overall Length
Crestpoint Management Limited
CA1631
In Commercial Distribution

  • G412CA16310 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Healon/Viscoelastic Injection Cannula 27ga, Flattened Round Tip, Angled 5mm from bend to tip at 40 degree, 29mm Overall Length
Crestpoint Management Limited
CA1426
In Commercial Distribution

  • G412CA14260 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Healon/Viscoelastic Injection Cannula 19ga, Flattened Round Tip, Angled 5mm from bend to tip at 40 degree, 29mm Overall Length
Crestpoint Management Limited
CA1425
In Commercial Distribution

  • G412CA14250 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Healon/Viscoelastic Injection Cannula 18ga, Flattened Round Tip, Angled 5mm from bend to tip at 40 degree, 29mm Overall Length
Crestpoint Management Limited
CA1424
In Commercial Distribution

  • G412CA14240 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
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