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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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O2 ACTIVE 9 17x15x3.5" - 08717261055978

Wheelchair cushion
Vicair B.V.
OCT9/4338
In Commercial Distribution

  • 08717261055978 ()

  • Width: 17 Inch
  • Depth: 15 Inch
  • Device Size Text, specify:


  • Wheelchair seat cushion

O2 ACTIVE 9 17x14x3.5" - 08717261055961

Wheelchair cushion
Vicair B.V.
OCT9/4335
In Commercial Distribution

  • 08717261055961 ()

  • Device Size Text, specify:
  • Width: 17 Inch
  • Depth: 14 Inch


  • Wheelchair seat cushion

O2 ACTIVE 9 16x21x3.5" - 08717261055954

Wheelchair cushion
Vicair B.V.
OCT9/4053
In Commercial Distribution

  • 08717261055954 ()

  • Width: 16 Inch
  • Device Size Text, specify:
  • Depth: 21 Inch


  • Wheelchair seat cushion

O2 ACTIVE 9 16x20x3.5" - 08717261055947

Wheelchair cushion
Vicair B.V.
OCT9/4050
In Commercial Distribution

  • 08717261055947 ()

  • Width: 16 Inch
  • Depth: 20 Inch
  • Device Size Text, specify:


  • Wheelchair seat cushion

O2 ACTIVE 9 16x19x3.5" - 08717261055930

Wheelchair cushion
Vicair B.V.
OCT9/4048
In Commercial Distribution

  • 08717261055930 ()

  • Width: 16 Inch
  • Depth: 19 Inch
  • Device Size Text, specify:


  • Wheelchair seat cushion

O2 ACTIVE 9 16x18x3.5" - 08717261055923

Wheelchair cushion
Vicair B.V.
OCT9/4045
In Commercial Distribution

  • 08717261055923 ()

  • Width: 16 Inch
  • Depth: 18 Inch
  • Device Size Text, specify:


  • Wheelchair seat cushion

O2 ACTIVE 9 16x17x3.5" - 08717261055916

Wheelchair cushion
Vicair B.V.
OCT9/4043
In Commercial Distribution

  • 08717261055916 ()

  • Depth: 17 Inch
  • Width: 16 Inch
  • Device Size Text, specify:


  • Wheelchair seat cushion

O2 ACTIVE 9 16x16x3.5" - 08717261055909

Wheelchair cushion
Vicair B.V.
OCT9/4040
In Commercial Distribution

  • 08717261055909 ()

  • Device Size Text, specify:
  • Depth: 16 Inch
  • Width: 16 Inch


  • Wheelchair seat cushion

O2 ACTIVE 9 16x15x3.5" - 08717261055893

Wheelchair cushion
Vicair B.V.
OCT9/4038
In Commercial Distribution

  • 08717261055893 ()

  • Device Size Text, specify:
  • Width: 16 Inch
  • Depth: 15 Inch


  • Wheelchair seat cushion

O2 ACTIVE 9 16x14x3.5" - 08717261055886

Wheelchair cushion
Vicair B.V.
OCT9/4035
In Commercial Distribution

  • 08717261055886 ()

  • Device Size Text, specify:
  • Width: 16 Inch
  • Depth: 14 Inch


  • Wheelchair seat cushion

O2 ACTIVE 9 15x19x3.5" - 08717261055879

Wheelchair cushion
Vicair B.V.
OCT9/3848
In Commercial Distribution

  • 08717261055879 ()

  • Width: 15 Inch
  • Device Size Text, specify:
  • Depth: 19 Inch


  • Wheelchair seat cushion

O2 ACTIVE 9 15x18x3.5" - 08717261055862

Wheelchair cushion
Vicair B.V.
OCT9/3845
In Commercial Distribution

  • 08717261055862 ()

  • Depth: 18 Inch
  • Width: 15 Inch
  • Device Size Text, specify:


  • Wheelchair seat cushion

O2 ACTIVE 9 15x17x3.5" - 08717261055855

Wheelchair cushion
Vicair B.V.
OCT9/3843
In Commercial Distribution

  • 08717261055855 ()

  • Device Size Text, specify:
  • Width: 15 Inch
  • Depth: 17 Inch


  • Wheelchair seat cushion

O2 ACTIVE 9 15x16x3.5" - 08717261055848

Wheelchair cushion
Vicair B.V.
OCT9/3840
In Commercial Distribution

  • 08717261055848 ()

  • Width: 15 Inch
  • Depth: 16 Inch
  • Device Size Text, specify:


  • Wheelchair seat cushion

O2 ACTIVE 9 15x15x3.5" - 08717261055831

Wheelchair cushion
Vicair B.V.
OCT9/3838
In Commercial Distribution

  • 08717261055831 ()

  • Width: 15 Inch
  • Device Size Text, specify:
  • Depth: 15 Inch


  • Wheelchair seat cushion

O2 ACTIVE 9 15x14x3.5" - 08717261055824

Wheelchair cushion
Vicair B.V.
OCT9/3835
In Commercial Distribution

  • 08717261055824 ()

  • Depth: 14 Inch
  • Device Size Text, specify:
  • Width: 15 Inch


  • Wheelchair seat cushion

O2 ACTIVE 9 14x18x3.5" - 08717261055817

Wheelchair cushion
Vicair B.V.
OCT9/3545
In Commercial Distribution

  • 08717261055817 ()

  • Device Size Text, specify:
  • Width: 14 Inch
  • Depth: 18 Inch


  • Wheelchair seat cushion

O2 ACTIVE 9 14x17x3.5" - 08717261055800

Wheelchair cushion
Vicair B.V.
OCT9/3543
In Commercial Distribution

  • 08717261055800 ()

  • Width: 14 Inch
  • Device Size Text, specify:
  • Depth: 17 Inch


  • Wheelchair seat cushion

O2 ACTIVE 9 14x16x3.5" - 08717261055794

Wheelchair cushion
Vicair B.V.
OCT9/3540
In Commercial Distribution

  • 08717261055794 ()

  • Width: 14 Inch
  • Depth: 16 Inch
  • Device Size Text, specify:


  • Wheelchair seat cushion

O2 ACTIVE 9 14x15x3.5" - 08717261055787

Wheelchair cushion
Vicair B.V.
OCT9/3538
In Commercial Distribution

  • 08717261055787 ()

  • Device Size Text, specify:
  • Width: 14 Inch
  • Depth: 15 Inch


  • Wheelchair seat cushion

O2 ACTIVE 9 14x14x3.5" - 08717261055770

Wheelchair cushion
Vicair B.V.
OCT9/3535
In Commercial Distribution

  • 08717261055770 ()

  • Device Size Text, specify:
  • Depth: 14 Inch
  • Width: 14 Inch


  • Wheelchair seat cushion

ColoCare - 9 Health Fair - M5255521380

No Description
HELENA LABORATORIES CORPORATION
552138
In Commercial Distribution

  • M5255521380 ()


  • Faecal occult blood IVD, kit, rapid colorimetric, clinical

DOA 9 PANEL TEST - 00817830022221

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / MTD / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD7072-06
In Commercial Distribution

  • 00817830022221 ()

  • Length: 75 Millimeter
07RD7072-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

DOA 9 PANEL TEST - 00817830022214

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / BUP / COC / M-AMP / MTD / OPI-II / THC
RAPID DIAGNOSTICS INC
07RD7072-02A
In Commercial Distribution

  • 00817830022214 ()

  • Length: 75 Millimeter
07RD7072-02A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

DOA 9 PANEL TEST - 00817830022207

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / BUP / COC / M-AMP / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7072-02
In Commercial Distribution

  • 00817830022207 ()

  • Length: 75 Millimeter
07RD7072-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

DOA 9 PANEL TEST - 00817830022191

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / MTD / OPI-II/ PCP / THC
RAPID DIAGNOSTICS INC
07RD7072-01A
In Commercial Distribution

  • 00817830022191 ()

  • Length: 75 Millimeter
07RD7072-01A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

DOA 9 PANEL TEST - 00817830022184

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / MTD / OPI / PCP / THC
RAPID DIAGNOSTICS INC
07RD7072-01
In Commercial Distribution

  • 00817830022184 ()

  • Length: 75 Millimeter
07RD7072-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Victory 9 3 Wheel - 00606509300377

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
Pride Mobility Products Corp
SC609/S609
In Commercial Distribution

  • 00606509300377 ()
N/A

  • Assistive scooter, electric-motor-driven

Victory 9 4 Wheel - 00606509300384

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
Pride Mobility Products Corp
SC709/S709
In Commercial Distribution

  • 00606509300384 ()
N/A

  • Assistive scooter, electric-motor-driven

BICRO-LITE ANKLE 9" MEDIUM - 00610570121519

No Description
Bird & Cronin, LLC
99000583
In Commercial Distribution

  • 00610570121519 ()


  • Ankle/foot orthosis

9" ABDOMINAL BINDER 55-72" - 00610570107285

No Description
Bird & Cronin, LLC
BC 0372
In Commercial Distribution

  • 00610570107285 ()


  • Abdominal binder, single-use

9" ABDOMINAL BINDER 46-62" - 00610570107278

No Description
Bird & Cronin, LLC
BC 0362
In Commercial Distribution

  • 00610570107278 ()


  • Abdominal binder, single-use

Origin Size 9 Template - 09348215074722

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-109
In Commercial Distribution

  • 09348215074722 ()


  • Surgical implant template, reusable

Aria Size 9 Template - 09348215073572

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-201-509
In Commercial Distribution

  • 09348215073572 ()


  • Surgical implant template, reusable

Tap Shaft Size 9 - 09348215068356

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
132-112-185
In Commercial Distribution

  • 09348215068356 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable

Conformity stem, collared, #9 - 04711605583022

Conformity stem, collared, #9
UNITED ORTHOPEDIC CORP.
1110-1009
In Commercial Distribution

  • 04711605583022 ()
1110-1009

  • Metal-on-polyethylene total hip prosthesis
  • Revision coated hip femur prosthesis
  • Coated hip femur prosthesis, modular

Global Reference Module 9 - 00850011306598

The Global Reference Module 9 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 9
In Commercial Distribution

  • 00850011306598 ()
31-0604-0051

  • Electroencephalographic signal amplifier

9" Stainless Steel Guidewire - 00858406007570

No Description
SURGENTEC, LLC
FC-G-16S
In Commercial Distribution

  • 00858406007570 ()


  • Spinal guidewire

Sealing Cap (Size 9) - 00858395006417

Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.
SONENDO, INC.
FG-001-00009
In Commercial Distribution

  • 00858395006417 ()
  • 00858395006141 ()
GW-MOL-SP09

  • Dental delivery system instrument unit, electric

Sealing Cap (Size 9) - 00858395006073

Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.
SONENDO, INC.
FG-001-00009
In Commercial Distribution

  • 00858395006073 ()
  • 00858395006141 ()
GW-MOL-SP09

  • Dental delivery system instrument unit, electric

Rayner Cataract Set 9 - 05404027444574

No Description
Hasa Optix
HA-SET009
In Commercial Distribution

  • 05404027446592 ()
  • 05404027444574 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

9" SINGLE CLAMP BAR - 00842430112775

No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
3017
In Commercial Distribution

  • 00842430112775 ()
3017

  • Bed traction frame

Zirconia ECO LINE 9 - D800ZRAE0501

No Description
ZIRKONZAHN SRL
ZRAE0501
In Commercial Distribution

  • D800ZRAE0501 ()


  • Dental bridge, ceramic

Prettau® Zirconia 9 - D800ZRAD0501

Content: 1 piece Height: 16 mm Highly translucent zirconia for single crowns to large bridges (fully anatomic structures or reduced structures for veneering with ceramics)
ZIRKONZAHN SRL
ZRAD0501
In Commercial Distribution

  • D800ZRAD0501 ()


  • Dental bridge, ceramic

EL-ANA PROFILES: ANA/9 - 00854473003071

ANTI-NUCLEAR ANTIBODY ELISA TEST KIT, 40 TESTS OF 9 INDIVIDUAL ANTIGENS
THERA-TEST LABORATORIES, INC
104-005
In Commercial Distribution

  • 00854473003071 ()
104-005

  • Centromere protein antibody (anti-CENP) IVD, kit, enzyme immunoassay (EIA)
  • Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA)
  • Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA)
  • SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)
  • SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)
  • Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA)
  • Smith antibody (anti-Sm) IVD, kit, enzyme immunoassay (EIA)
  • Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)
  • Single stranded DNA antibody (anti-ssDNA) IVD, kit, enzyme immunoassay (EIA)

DVD Phonak Target 9 - 07613389709483

No Description
Sonova AG
9.1
In Commercial Distribution

  • 07613389709483 ()
058-0125-091

  • Audiometric/hearing device software

Scan Post 9 mm - 07290109742953

Scan Post 9 mm
BHI IMPLANTS LTD
1
In Commercial Distribution

  • 07290109742953 ()

  • Height: 9.0 Millimeter
BH-SP4509

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

Voss 9" Round Support - 00811304020539

9" disposable foam round head support
VM/POSITIONING, INC.
714-9RS
In Commercial Distribution

  • 00811304020539 ()

  • Length: 9 Inch


  • Freestanding patient positioner, single-use

HEAD FEMORAL 32mm +9 - M209191350

No Description
BIOPRO, INC.
19135
In Commercial Distribution

  • M209191350 ()


  • Metal-on-polyethylene total hip prosthesis

HEAD FEMORAL 36mm +9 - M209190570

No Description
BIOPRO, INC.
19057
In Commercial Distribution

  • M209190570 ()


  • Metal-on-polyethylene total hip prosthesis
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