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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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Sklar - 50649111439863

OP SCISS STR B/B 5.5 INCHESSTRLCS/25
SKLAR CORPORATION
96-2259M
In Commercial Distribution

  • 50649111439863 ()
  • 00649111439868 ()


  • General-purpose surgical scissors, single-use

Sklar - 50649111439856

OP SCISS STR B/B 5.5 INCHESSTRLCS/25
SKLAR CORPORATION
96-2259
In Commercial Distribution

  • 50649111439856 ()
  • 00649111439851 ()


  • General-purpose surgical scissors, single-use

Telio Desensitizer - DVIV707177AN1

FLK Syntac Adhesive B, FLK Syntac Adhesive B
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
707177AN
Not in Commercial Distribution

  • DIVO707177AN0 ()
  • DVIV707177AN1 ()
707177AN

  • Dental coating, tooth-desensitizing, professional

ANKYLOS® - 07392532221286

Wax-Up Coping b/1.5/6.0 & b/3.0/6.0
Dentsply Implants Manufacturing GmbH
31045210
In Commercial Distribution

  • 07392532221286 ()
31045210

  • Dental implant suprastructure, temporary, preformed, single-use

ANKYLOS® - 07392532221262

Wax-Up Coping b/1.5/4.0 & b/3.0/4.0
Dentsply Implants Manufacturing GmbH
31045200
In Commercial Distribution

  • 07392532221262 ()
31045200

  • Dental implant suprastructure, temporary, preformed, single-use

Bausch + Lomb - 00757770417605

4 1/2" PAR SCISSORS,CURVED B/B
Bausch & Lomb Incorporated
P0930
In Commercial Distribution

  • 00757770417605 ()
P0930

  • Corneal scissors, reusable

Surgical Direct - B382SD13238130

5mm 45cm Atraumatic, Endo-Clinch Grasper, Wtih On/Off Style Ratchet Reinforced, Carbon Fiber Com
Surgical Direct, Inc.
SD13238-13
In Commercial Distribution

  • B382SD13238130 ()
SD13238-13

  • Flexible endoscopic tissue manipulation forceps, single-use

Surgical Direct - B382SD15718250

5mm 32cm Hunter Bowel Grasper, Fenestrated, 22mm Jaw, With Non-Locking, Reinforced, Carbon Fiber Com
Surgical Direct, Inc.
SD15718-25
In Commercial Distribution

  • B382SD15718250 ()
SD15718-25

  • Flexible endoscopic tissue manipulation forceps, single-use

Surgical Direct - B382SD13818210

5mm 36cm Atraumatic, Long Jaw, Wave Grasper, Single Action Non-Locking, Reinforced, Carbon Fiber Com
Surgical Direct, Inc.
SD13818-21
In Commercial Distribution

  • B382SD13818210 ()
SD13818-21

  • Flexible endoscopic tissue manipulation forceps, single-use

Surgical Direct - B382SD13128250

5mm 32cm Johan Grasper, 22mm Single Action Jaws, Rotating, Non-Locking, Reinforced, Carbon Fiber Com
Surgical Direct, Inc.
SD13128-25
In Commercial Distribution

  • B382SD13128250 ()
SD13128-25

  • Flexible endoscopic tissue manipulation forceps, single-use

SpO2.COM® NRC-P12 Patient Cable - 00843997001380

No Description
MASIMO CORPORATION
1853
In Commercial Distribution

  • 00843997001380 ()


  • Electrical-only medical device connection cable, reusable

SpO2.COM® NRC-180 Patient Cable - 00843997001359

No Description
MASIMO CORPORATION
1810
In Commercial Distribution

  • 00843997001359 ()


  • Electrical-only medical device connection cable, reusable

ACCURUN® 2 Series 5600 - 00860006589783

No Description
Lgc Clinical Diagnostics, Inc.
2000-0100
In Commercial Distribution

  • 00860006589783 ()


  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00860006589776

No Description
Lgc Clinical Diagnostics, Inc.
2000-0079
In Commercial Distribution

  • 00860006589776 ()


  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00860006589707

No Description
Lgc Clinical Diagnostics, Inc.
2000-0080
In Commercial Distribution

  • 00860006589707 ()


  • Multiple blood-borne virus antigen/antibody IVD, control

EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) - 04049016124894

No Description
EUROIMMUN Medizinische Labordiagnostika AG
DL 1300-6401-8 G
In Commercial Distribution

  • 04049016124894 ()


  • Multiple liver disease-associated antibody IVD, kit, enzyme immunoassay (EIA)

EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) - 04049016124887

No Description
EUROIMMUN Medizinische Labordiagnostika AG
DL 1300-1601-8 G
In Commercial Distribution

  • 04049016124887 ()


  • Multiple liver disease-associated antibody IVD, kit, enzyme immunoassay (EIA)

VIROTROL - 03610520530146

VIROTROL PLUS-R (An unassayed (human) serology control)
BIO-RAD LABORATORIES, INC.
12000539
In Commercial Distribution

  • 03610520530146 ()
12000539

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 03610520530139

VIROTROL PLUS-R (An unassayed (human) serology control)
BIO-RAD LABORATORIES, INC.
12000538
In Commercial Distribution

  • 03610520530139 ()
12000538

  • Multiple blood-borne virus antigen/antibody IVD, control

ABBOTT PRISM - 00380740039219

ABBOTT PRISM Positive Run Control Kit
ABBOTT LABORATORIES
3E60-11
Not in Commercial Distribution

  • 00380740039219 ()
03E6011

  • Multiple blood-borne virus antigen/antibody IVD, control

ABBOTT PRISM - 00380740038403

ABBOTT PRISM Run Control Kit
ABBOTT LABORATORIES
3E60-10
Not in Commercial Distribution

  • 00380740038403 ()
03E6010

  • Multiple blood-borne virus antigen/antibody IVD, control

Remel - 00848838068416

Xpect C. diff Toxin A/B KT/40TST
REMEL, INC.
R24640
In Commercial Distribution

  • 30848838068417 ()
  • 00848838068416 ()


  • Clostridium difficile antigen IVD, kit, rapid ICT, clinical

Remel - 00848838027093

Xpect C. diff Toxin A/B KT/20TST
REMEL, INC.
R24650
In Commercial Distribution

  • 30848838027094 ()
  • 00848838027093 ()


  • Clostridium difficile antigen IVD, kit, rapid ICT, clinical

VIROTROL - 00847661005780

VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00102C
In Commercial Distribution

  • 00847661005780 ()
00102C

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661005773

VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00102B
In Commercial Distribution

  • 00847661005773 ()
00102B

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661005629

VIROTROL II (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00115B
In Commercial Distribution

  • 00847661005629 ()
00115B

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661005551

VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00101G
In Commercial Distribution

  • 00847661005551 ()
00101G

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661005544

VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00101F
In Commercial Distribution

  • 00847661005544 ()
00101F

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661005537

VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00101E
In Commercial Distribution

  • 00847661005537 ()
00101E

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661005520

VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00101C
In Commercial Distribution

  • 00847661005520 ()
00101C

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661005513

VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00101B
In Commercial Distribution

  • 00847661005513 ()
00101B

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661005506

VIROTROL II (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00104B
In Commercial Distribution

  • 00847661005506 ()
00104B

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661005490

VIROTROL II (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00104A
In Commercial Distribution

  • 00847661005490 ()
00104A

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661005421

VIROTROL II (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00115A
In Commercial Distribution

  • 00847661005421 ()
00115A

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661005322

VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00100B
In Commercial Distribution

  • 00847661005322 ()
00100B

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661004776

VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00100H
In Commercial Distribution

  • 00847661004776 ()
00100H

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661004769

VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00100F
In Commercial Distribution

  • 00847661004769 ()
00100F

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661004752

VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00100E
In Commercial Distribution

  • 00847661004752 ()
00100E

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661004745

VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00100G
In Commercial Distribution

  • 00847661004745 ()
00100G

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 00847661004738

VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00100C
In Commercial Distribution

  • 00847661004738 ()
00100C

  • Multiple blood-borne virus antigen/antibody IVD, control
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