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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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Hayden Medical - 00840319700983

Operating Scissors 4-1/2" (11.3cm), straight B/B
Hayden Medical, Inc.
100-022
In Commercial Distribution

  • 00840319700983 ()
100-022

  • General-purpose surgical scissors, reusable

gSource - 00840314201744

Operating Scissors 6 1/2" cvd b/b
GSOURCE LLC
gS 13.4036
In Commercial Distribution

  • 00840314201744 ()
gS 13.4036

  • Bandage scissors, reusable

gSource - 00840314201713

Operating Scissors 6 1/2" str b/b
GSOURCE LLC
gS 13.4033
In Commercial Distribution

  • 00840314201713 ()
gS 13.4033

  • Bandage scissors, reusable

gSource - 00840314201676

Operating Scissors 5 1/2" cvd b/b
GSOURCE LLC
gS 13.4026
In Commercial Distribution

  • 00840314201676 ()
gS 13.4026

  • Bandage scissors, reusable

gSource - 00840314201645

Operating Scissors 5 1/2" str b/b
GSOURCE LLC
gS 13.4023
In Commercial Distribution

  • 00840314201645 ()
gS 13.4023

  • Bandage scissors, reusable

gSource - 00840314201522

Operating Scissors 4 1/2" cvd b/b
GSOURCE LLC
gS 13.4006
In Commercial Distribution

  • 00840314201522 ()
gS 13.4006

  • Bandage scissors, reusable

gSource - 00840314201492

Operating Scissors 4 1/2" str b/b
GSOURCE LLC
gS 13.4003
In Commercial Distribution

  • 00840314201492 ()
gS 13.4003

  • Bandage scissors, reusable

Hayden Medical - 00840319735916

Deaver Scissors 5-1/2" (14cm), straight B/B
Hayden Medical, Inc.
100-104
In Commercial Distribution

  • 00840319735916 ()
100-104

  • General-purpose surgical scissors, reusable

Avalign - 00190776235383

O.R. Sci, B/B, cvd, 6 1/2"
Avalign Technologies, Inc.
VM21-4184
In Commercial Distribution

  • 00190776235383 ()


  • General-purpose surgical scissors, reusable

N/A - 00840329809034

B&B EMORY ENDOPLASTIC BREAST DISSECTOR; 13''(33CM)
BLACK & BLACK SURGICAL, INC.
B65220
In Commercial Distribution

  • 00840329809034 ()
B65220

  • Open-surgery dissector

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

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

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

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 - 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

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

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

VIROTROL - 00847661004707

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

  • 00847661004707 ()
00101D

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

VIROTROL - 00847661004684

VIROTROL III (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00110A
In Commercial Distribution

  • 00847661004684 ()
00110A

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

VIROTROL - 00847661004585

VIROTROL III (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00110C
In Commercial Distribution

  • 00847661004585 ()
00110C

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

VIROTROL - 00847661004240

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

  • 00847661004240 ()
00100A

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

VIROCLEAR - 00847661002581

VIROCLEAR (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00107
In Commercial Distribution

  • 00847661002581 ()
00107

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

VIROCLEAR - 00847661002574

VIROCLEAR (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00112
In Commercial Distribution

  • 00847661002574 ()
00112

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

VIROCLEAR - 00847661002567

VIROCLEAR (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00106
In Commercial Distribution

  • 00847661002567 ()
00106

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

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

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

QUANTA Lite® PBC Screen IgG/IgA ELISA - 08426950594239

1. 1x PBC Screen IgG/IgA ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted PBC Screen IgG/IgA ELISA Low Positive 4. 1x 1.2mL prediluted PBC Screen IgG/IgA ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP PBC Screen IgG/IgA Conjugate, (goat), anti-human IgG/IgA 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
704560
In Commercial Distribution

  • 08426950594239 ()


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