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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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G-CEM LinkAce™ - D0470048601

G-CEM LinkAce™ BO1, 2 x syringes, 15 GC Automix Tips, 5 x GC Automix Tips for Endo
Gc America Inc.
004860
Not in Commercial Distribution

  • D0470048601 ()
004860

  • Dental composite resin

G-CEM LinkAce™ - D0470048591

G-CEM LinkAce™ AO3, 2 x syringes, 15 GC Automix Tips, 5 x GC Automix Tips for Endo
Gc America Inc.
004859
Not in Commercial Distribution

  • D0470048591 ()
004859

  • Dental composite resin

G-CEM LinkAce™ - D0470048581

G-CEM LinkAce™ Translucent, 2 x syringes, 15 GC Automix Tips, 5 x GC Automix Tips for Endo
Gc America Inc.
004858
Not in Commercial Distribution

  • D0470048581 ()
004858

  • Dental composite resin

G-CEM LinkAce™ - D0470048571

G-CEM LinkAce™ A2, 2 x syringes (4.6g) 15 GC Automix Tips,
Gc America Inc.
004857
Not in Commercial Distribution

  • D0470048571 ()
004857

  • Dental composite resin

Surgical Direct - B382SD908192350

8 1/8 inch Garrett Vascular Dilator, Malleable, 3.5mm Tip
Surgical Direct, Inc.
SD90819235
In Commercial Distribution

  • B382SD908192350 ()
SD90819235

  • Laparoscopic access cannula, reusable

Surgical Direct - B382SD908192300

8 1/8 inch Garrett Vascular Dilator, Malleable, 3mm Tip
Surgical Direct, Inc.
SD90819230
In Commercial Distribution

  • B382SD908192300 ()
SD90819230

  • Laparoscopic access cannula, reusable

Surgical Direct - B382SD908192250

8 1/8 inch Garrett Vascular Dilator, Malleable, 2.5mm Tip
Surgical Direct, Inc.
SD90819225
In Commercial Distribution

  • B382SD908192250 ()
SD90819225

  • Laparoscopic access cannula, reusable

Surgical Direct - B382SD908192200

8 1/8 inch Garrett Vascular Dilator, Malleable, 2mm Tip
Surgical Direct, Inc.
SD90819220
In Commercial Distribution

  • B382SD908192200 ()
SD90819220

  • Laparoscopic access cannula, reusable

Surgical Direct - B382SD907232010

8 5/8" Obwegeser Spine Retractor, Straight, 40mm x 10mm
Surgical Direct, Inc.
SD90723201
In Commercial Distribution

  • B382SD907232010 ()
SD90723201

  • Self-retaining surgical retractor, reusable

Surgical Direct - B382S26911020

8 7/8" Bayonet Bipolar Forceps, 1.5mm Gold Tips, Titanium
Surgical Direct, Inc.
S2691.102
In Commercial Distribution

  • B382S26911020 ()
S2691.102

  • Endoscopic electrosurgical handpiece/electrode, bipolar, reusable
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