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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 18x19x3.5" - 08717261056111

Wheelchair cushion
Vicair B.V.
OCT9/4548
In Commercial Distribution

  • 08717261056111 ()

  • Depth: 19 Inch
  • Width: 18 Inch
  • Device Size Text, specify:


  • 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

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

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

HEAD FEMORAL 28mm +9 - M209190080

No Description
BIOPRO, INC.
19008
In Commercial Distribution

  • M209190080 ()


  • Metal-on-polyethylene total hip prosthesis

HEAD FEMORAL 28mm +9 - M209185920

No Description
BIOPRO, INC.
18592
In Commercial Distribution

  • M209185920 ()


  • Metal-on-polyethylene total hip prosthesis

STEM PC XSHORT 9 - M209173390

No Description
BIOPRO, INC.
17339
In Commercial Distribution

  • M209173390 ()


  • Press-fit hip femur prosthesis, modular

STEM PC SH 9 - M209101380

No Description
BIOPRO, INC.
10138
In Commercial Distribution

  • M209101380 ()


  • Press-fit hip femur prosthesis, modular

Hose, N2O DISS 9' - 00813830021882

No Description
ACCUTRON, INC.
34062-9
In Commercial Distribution

  • 00813830021882 ()
34062-9

  • Medical gas pipeline system

Hose, O2 DISS 9' - 00813830021868

No Description
ACCUTRON, INC.
34061-9
In Commercial Distribution

  • 00813830021868 ()
34061-9

  • Medical gas pipeline system

DVD Phonak Target 9 - 07613389709483

No Description
Sonova AG
9.1
In Commercial Distribution

  • 07613389709483 ()
058-0125-091

  • Audiometric/hearing device software

Carbonic Anhydrase 9 RMab - B502BSB64200

Carbonic Anhydrase 9 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB64200 ()
BSB 6420

  • Carbonic anhydrase IVD, antibody

Carbonic Anhydrase 9 RMab - B502BSB64190

Carbonic Anhydrase 9 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB64190 ()
BSB 6419

  • Carbonic anhydrase IVD, antibody

Carbonic Anhydrase 9 RMab - B502BSB64180

Carbonic Anhydrase 9 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB64180 ()
BSB 6418

  • Carbonic anhydrase IVD, antibody

FIXED REAMER, 9 MM - 00888480266143

No Description
Biomet Orthopedics, LLC
29413
In Commercial Distribution

  • 00888480266143 ()
29413

  • Bone-resection orthopaedic reamer, reusable

System 9 CD NXT - 07613327592856

Handpiece
STRYKER CORPORATION
4607000000
In Commercial Distribution

  • 07613327592856 ()
4607-000-000

  • Bone/joint surgical power tool motor, electric

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

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

THC PLUS LEVEL 9 - B800THC9UFWCT0

THC PLUS LEVEL 9
UTAK LABORATORIES, INC.
THC+ 9 U F WCT
In Commercial Distribution

  • B800THC9UFWCT5 ()
  • B800THC9UFWCT0 ()

  • Total Volume: 10 Milliliter
THC+ 9 U F WCT

  • Multiple-type clinical chemistry analyte profile IVD, control

CERVICAL COIL N.9 - 08056304452870

Coil for G-scan Brio
ESAOTE SPA
131000400
In Commercial Distribution

  • 08056304452870 ()


  • MRI system coil, radio-frequency

DEPTH GAUGE 9 mm - 08055727374578

No Description
HPF SRL
9095.11.302
In Commercial Distribution

  • 08055727374578 ()


  • Surgical depth gauge, reusable

DEPTH GAUGE 9 mm - 08055727374561

No Description
HPF SRL
H0010354099
In Commercial Distribution

  • 08055727374561 ()


  • Surgical depth gauge, reusable

Molt #9 Periosteal Elevator - 00810060722664

No Description
Berman Instruments LLC
EP009
Not in Commercial Distribution

  • 00810060722664 ()


  • Dental elevator, tooth/root

Provox LaryTube 9/55 - 07331791002175

Provox LaryTube is a holder for devices in the Provox HME System intended for vocal and pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. The Provox LaryTube is intended for single patient use. The Standard model is made for use with or without a voice prosthesis. The Standard model can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users. The standard model can be attached with a Provox TubeHolder or Provox LaryClips.
Atos Medical AB
7607
In Commercial Distribution

  • 07331791002175 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
  • Outer Diameter: 13.5 Millimeter
  • Length: 55 Millimeter
7607

  • Tracheostomy tube, non-reinforced, non-customized, reusable
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