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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IVD reagent kit containing 30 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0136
Not in Commercial Distribution

  • 00815381020291 ()
RFIT-ASY-0136

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
423883
In Commercial Distribution

  • 00815381020239 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 6 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0145
In Commercial Distribution

  • 00815381020185 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0144
In Commercial Distribution

  • 00815381020178 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 6 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0130
Not in Commercial Distribution

  • 00815381020161 ()
RFIT-ASY-0130

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0129
Not in Commercial Distribution

  • 00815381020154 ()
RFIT-ASY-0129

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0120
Not in Commercial Distribution

  • 00815381020147 ()
RFIT-ASY-0120

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0125
Not in Commercial Distribution

  • 00815381020079 ()
RFIT-ASY-0125

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0124
Not in Commercial Distribution

  • 00815381020062 ()
RFIT-ASY-0124

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert Xpress CoV-2/Flu/RSV plus
CEPHEID
XPRS4PLEX-10
In Commercial Distribution

  • 07332940008604 ()
XPRS4PLEX-10

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
20 tests/kit
In Commercial Distribution

  • 06974849369137 ()


  • Beta-haemolytic Group B Streptococcus antigen IVD, kit, rapid ICT, clinical
No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
5 tests/kit
In Commercial Distribution

  • 06974849369120 ()


  • Beta-haemolytic Group B Streptococcus antigen IVD, kit, rapid ICT, clinical
No Description
Biocartis NV
1.0
Not in Commercial Distribution

  • 15415219000635 ()
  • 05415219000638 ()
A1030/6

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Inst: Scissor Curv 4.5in B/B 20/Bx
MEDICAL ACTION INDUSTRIES INC.
73649
In Commercial Distribution

  • 20809160003739 ()
  • 10809160003732 ()
  • 30809160003736 ()


  • General-purpose surgical scissors, single-use
Operating Scissors 6 1/2" str b/b
GSOURCE LLC
gS 13.4033
In Commercial Distribution

  • 00840314201713 ()
gS 13.4033

  • Bandage scissors, reusable
Operating Scissors 4 1/2" cvd b/b
GSOURCE LLC
gS 13.4006
In Commercial Distribution

  • 00840314201522 ()
gS 13.4006

  • Bandage scissors, reusable
Operating Scissors 6-1/2" (16.3cm), curved B/B
Hayden Medical, Inc.
100-058
In Commercial Distribution

  • 00840319701164 ()
100-058

  • General-purpose surgical scissors, reusable
Operating Scissors 5-1/2" (13.8cm), curved B/B
Hayden Medical, Inc.
100-056
In Commercial Distribution

  • 00840319701157 ()
100-056

  • General-purpose surgical scissors, reusable
Operating Scissors 4-1/2" (11.3cm), curved B/B
Hayden Medical, Inc.
100-052
In Commercial Distribution

  • 00840319701133 ()
100-052

  • General-purpose surgical scissors, reusable
Operating Scissors 6-1/2" (16.3cm), straight B/B
Hayden Medical, Inc.
100-028
In Commercial Distribution

  • 00840319701027 ()
100-028

  • General-purpose surgical scissors, reusable
Operating Scissors 5-1/2" (13.8cm), straight B/B
Hayden Medical, Inc.
100-026
In Commercial Distribution

  • 00840319701003 ()
100-026

  • General-purpose surgical scissors, reusable
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
g2 Stevens Tenotomy Scissors 4" cvd b/b
GSOURCE LLC
SC.13.2720
In Commercial Distribution

  • 00840314250711 ()
SC.13.2720

  • Tenotome
g2 Stevens Tenotomy Scissors 4" str b/b
GSOURCE LLC
SC.13.2680
In Commercial Distribution

  • 00840314250704 ()
SC.13.2680

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

  • 00840314201744 ()
gS 13.4036

  • Bandage scissors, reusable
Operating Scissors 5 1/2" cvd b/b
GSOURCE LLC
gS 13.4026
In Commercial Distribution

  • 00840314201676 ()
gS 13.4026

  • Bandage scissors, reusable
Operating Scissors 5 1/2" str b/b
GSOURCE LLC
gS 13.4023
In Commercial Distribution

  • 00840314201645 ()
gS 13.4023

  • Bandage scissors, reusable
Operating Scissors 4 1/2" str b/b
GSOURCE LLC
gS 13.4003
In Commercial Distribution

  • 00840314201492 ()
gS 13.4003

  • Bandage scissors, reusable
Handle for 10386 A/B, 10389 A/B
Karl Storz GmbH & Co. KG
10386VH
In Commercial Distribution

  • 04048551048191 ()


  • Surgical instrument handle, non-torque-limiting
O.R. Sci, B/B, cvd, 6 1/2"
Avalign Technologies, Inc.
VM21-4184
In Commercial Distribution

  • 00190776235383 ()


  • General-purpose surgical scissors, reusable
B&B EMORY ENDOPLASTIC BREAST DISSECTOR; 13''(33CM)
BLACK & BLACK SURGICAL, INC.
B65220
In Commercial Distribution

  • 00840329809034 ()
B65220

  • Open-surgery dissector
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
FLK Syntac Adhesive B, FLK Syntac Adhesive B
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
707177AN
Not in Commercial Distribution

  • DIVO707177AN0 ()
  • DVIV707177AN1 ()
707177AN

  • Dental coating, tooth-desensitizing, professional
Leadwire B/B 100cm 40" ~ safety socket pin
DJO, LLC
193068-100
In Commercial Distribution

  • 00888912256568 ()


  • Transcutaneous electrical stimulation lead
OPERATING SCISS 6 1/2 CVD B/B
SKLAR CORPORATION
97-300
In Commercial Distribution

  • 10649111150906 ()


  • General-purpose surgical scissors, reusable
OPER SCISSOR CVD B/B 4 1/2"
SKLAR CORPORATION
97-270
In Commercial Distribution

  • 10649111146480 ()


  • General-purpose surgical scissors, reusable
CENSITRAC READY OP SCISS STR B/B 5.5"
SKLAR CORPORATION
15-1055C
In Commercial Distribution

  • 10649111388309 ()


  • General-purpose surgical scissors, reusable
4 inch Knapp Iris Scissors, Curved , B/B
Surgical Direct, Inc.
SD903467102
In Commercial Distribution

  • B382SD9034671020 ()
SD903467102

  • General-purpose surgical scissors, single-use
4 inch Knapp Iris Scissors, Straight, B/B
Surgical Direct, Inc.
SD903466102
In Commercial Distribution

  • B382SD9034661020 ()
SD903466102

  • General-purpose surgical scissors, single-use
10" Metzenbaum Nelson Scissors, Curved, B/B, TC
Surgical Direct, Inc.
SD90397124
In Commercial Distribution

  • B382SD903971240 ()
SD90397124

  • General-purpose surgical scissors, single-use
TC OP SCISS B/B CVD 6.5 CERAM
SKLAR CORPORATION
16-9003
In Commercial Distribution

  • 10649111402241 ()


  • General-purpose surgical scissors, reusable
TC OP SCISS B/B CVD 5.75 CERAM
SKLAR CORPORATION
16-9002
In Commercial Distribution

  • 10649111402234 ()


  • General-purpose surgical scissors, reusable
TC OP SCISS B/B STR 6.5 CERAM
SKLAR CORPORATION
16-9001
In Commercial Distribution

  • 10649111402227 ()


  • General-purpose surgical scissors, reusable
TC OP SCISS B/B STR 5.75 CERAM
SKLAR CORPORATION
16-9000
In Commercial Distribution

  • 10649111402210 ()


  • General-purpose surgical scissors, reusable
ECONO STERILE OPERATING SCISSOR 5.5" B/B C50
SKLAR CORPORATION
94-1346
In Commercial Distribution

  • 50649111256613 ()
  • 10649111256615 ()


  • General-purpose surgical scissors, single-use
IRIS SCISS CVD B/B 4 1/2"
SKLAR CORPORATION
47-1244
In Commercial Distribution

  • 10649111251559 ()


  • Intraocular scissors, conventional-hinge, reusable
IRIS SCISS CVD B/B 3 1/2"
SKLAR CORPORATION
47-1240
In Commercial Distribution

  • 10649111250972 ()


  • Intraocular scissors, conventional-hinge, reusable
IRIS SCISS STR B/B 4 1/2"
SKLAR CORPORATION
47-1144
In Commercial Distribution

  • 10649111236549 ()


  • Intraocular scissors, conventional-hinge, reusable
IRIS SCISS B/B STR 3 1/2"
SKLAR CORPORATION
47-1140
In Commercial Distribution

  • 10649111235757 ()


  • Intraocular scissors, conventional-hinge, reusable
TC MAYO DISS SCIS STR B/B 6.75
SKLAR CORPORATION
16-3532
In Commercial Distribution

  • 10649111285660 ()


  • General-purpose surgical scissors, reusable
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