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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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EarQ - 04056839022887

EarQ HA LPL EAR Q P BT 7PX GB Hearing Aid
Ws Audiology Usa, Inc.
HA LPL EAR Q P BT 7PX GB
In Commercial Distribution

  • 04056839022887 ()
10948062

  • Air-conduction hearing aid, behind-the-ear

EarQ - 04056839022863

EarQ HA LPL EAR Q P BT 7PX GR Hearing Aid
Ws Audiology Usa, Inc.
HA LPL EAR Q P BT 7PX GR
In Commercial Distribution

  • 04056839022863 ()
10948064

  • Air-conduction hearing aid, behind-the-ear

EarQ - 04056839022856

EarQ HA LPL EAR Q P BT 7PX PRL Hearing Aid
Ws Audiology Usa, Inc.
HA LPL EAR Q P BT 7PX PRL
In Commercial Distribution

  • 04056839022856 ()
10948065

  • Air-conduction hearing aid, behind-the-ear

EarQ - 04056839022849

EarQ HA LPL EAR Q P BT 7PX SB Hearing Aid
Ws Audiology Usa, Inc.
HA LPL EAR Q P BT 7PX SB
In Commercial Distribution

  • 04056839022849 ()
10948066

  • Air-conduction hearing aid, behind-the-ear

EarQ - 04056839022832

EarQ HA LPL EAR Q P BT 7PX SLV Hearing Aid
Ws Audiology Usa, Inc.
HA LPL EAR Q P BT 7PX SLV
In Commercial Distribution

  • 04056839022832 ()
10948067

  • Air-conduction hearing aid, behind-the-ear

Damon - 00889989080490

Damon Clear SPK Upr 5-5/Lwr 3-3 Damon Q Lwr Bic
ORMCO CORPORATION
740-1408
In Commercial Distribution

  • 00889989080490 ()

  • Slot size: .022"


  • Orthodontic bracket, ceramic

NA - 10886982292551

RETENTION PIN FOR SCREWDRIVER W/ Q C -HEX 12MM/SHORT/XL25
Synthes GmbH
03.045.008
In Commercial Distribution

  • 07612334167859 ()
  • 10886982292551 ()
03045008

  • Orthopaedic instrument surgical connector

VBR™ vertebral body replacement - 04052536004041

VBR center piece, size Q, Ø 28 mm, height 42-58 mm
Ulrich GmbH & Co. KG
CS 2228-4258-1
Not in Commercial Distribution

  • 04052536004041 ()
CS 2228-4258-1

  • Vertebral body prosthesis

ComPel Surgical Drape - 00634916005561

RECTANGULAR LEGGING 1 PLY - 30X50 COMPEL W/WHT BINDING W/Q
STANDARD TEXTILE CO., INC.
27751402
In Commercial Distribution

  • 00634916005561 ()
  • 10634916005568 ()
27751402

  • Patient surgical drape, reusable

Barrier Supreme Wrapper - 00634916005530

WRAPPER BARR SUP 45X45 MISTY - MERROWED W/WHITE THREAD Q/QCM2
STANDARD TEXTILE CO., INC.
21625002
In Commercial Distribution

  • 00634916005530 ()
  • 10634916005530 ()
21625002

  • Sterilization packaging, reusable

NA - 00842307103646

WHEELCHAIR,32X20DP,REM ARM,Q/R 700 LB CAPACITY,REGENCY XL2000
GENDRON, INC.
6732-20-61-78-28-8
Not in Commercial Distribution

  • 00842307103646 ()


  • Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

NA - 00842307103608

WHEELCHAIR,26x20DP,REM ARM,Q/R 700 LB CAPACITY,REGENCY XL2000
GENDRON, INC.
6726-20-63-78-36-86-6
Not in Commercial Distribution

  • 00842307103608 ()


  • Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

NA - 00842307103134

WHEELCHAIR,24X18DP,ADJ HGT ARM,Q/R700 LB CAPACITY,REGENCY XL2000
GENDRON, INC.
6724-18-63-78-29-8
Not in Commercial Distribution

  • 00842307103134 ()


  • Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

NA - 00842307103080

WHEELCHAIR,30X20DP,REM ARM,Q/R 700 LB CAPACITY,REGENCY XL2000
GENDRON, INC.
6730-20-62-78-29-8
Not in Commercial Distribution

  • 00842307103080 ()


  • Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

NA - 00842307102960

WHEELCHAIR,22X20DP,REM ARM,Q/R 700 LB CAPACITY,REGENCY XL2000
GENDRON, INC.
6722-20-62-29-8
Not in Commercial Distribution

  • 00842307102960 ()


  • Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

NA - 00842307102724

WHEELCHAIR,26X22DP,REM ARM,Q/R 700 LB CAPACITY,REGENCY XL2000
GENDRON, INC.
6726-22-62-78-28-8
Not in Commercial Distribution

  • 00842307102724 ()


  • Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

NA - 00842307102694

WHEELCHAIR,20X22DP,HGT ADJ ARM,Q/R700 LB CAPACITY,REGENCY XL2000
GENDRON, INC.
6720-22-63-29-8
Not in Commercial Distribution

  • 00842307102694 ()


  • Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

NA - 00842307100638

WHEELCHAIR,30X20DP,REM ARM,Q/R 700 LB CAPACITY,REGENCY XL2000
GENDRON, INC.
6730-20-62-29-8
Not in Commercial Distribution

  • 00842307100638 ()


  • Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

NA - 00842307100621

WHEELCHAIR,26X20DP,REM ARM,Q/R 700 LB CAPACITY,REGENCY XL2000
GENDRON, INC.
6726-20-62-28-8
Not in Commercial Distribution

  • 00842307100621 ()


  • Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

NA - 00842307102267

WHEELCHAIR,32X20DP,REM ARM,Q/R 700 LB CAPACITY,REGENCY XL2000
GENDRON, INC.
6732-20-61-78-29-8
Not in Commercial Distribution

  • 00842307102267 ()


  • Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

NA - 00842307101857

WHEELCHAIR,28X20DP,REM ARM,Q/R 700 LB CAPACITY,REGENCY XL2000
GENDRON, INC.
6728-20-62-78-29-46-8
Not in Commercial Distribution

  • 00842307101857 ()


  • Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

NA - 00842307101840

WHEELCHAIR,32X20DP,REM ARM,Q/R 700 LB CAPACITY,REGENCY XL2000
GENDRON, INC.
6732-20-62-78-29-46-8
Not in Commercial Distribution

  • 00842307101840 ()


  • Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

NA - 00842307101833

WHEELCHAIR,30X20DP,REM ARM,Q/R 700 LB CAPACITY,REGENCY XL2000
GENDRON, INC.
6730-20-62-78-29-46-8
Not in Commercial Distribution

  • 00842307101833 ()


  • Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

NA - 00842307101796

WHEELCHAIR,26X20DP,REM ARM,Q/R 700 LB CAPACITY,REGENCY XL2000
GENDRON, INC.
6726-20-62-28-46-8
Not in Commercial Distribution

  • 00842307101796 ()


  • Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

NA - 00842307101550

WHEELCHAIR,32X18DP,REM ARM,Q/R 700 LB CAPACITY,REGENCY XL2000
GENDRON, INC.
6732-18-62-29-8
Not in Commercial Distribution

  • 00842307101550 ()


  • Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

NA - 00842307101062

WHEELCHAIR,28X20DP,HGT ADJ ARM,Q/R700 LB CAPACITY,REGENCY XL2000
GENDRON, INC.
6728-20-63-78-36-13-8
Not in Commercial Distribution

  • 00842307101062 ()


  • Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

NA - 00842307100300

WHEELCHAIR,30X18DP,REM ARM,Q/R 700 LB CAPACITY,REGENCY XL2000
GENDRON, INC.
6730-18-62-33-8
Not in Commercial Distribution

  • 00842307100300 ()


  • Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

NA - 00842307100270

WHEELCHAIR,28X20DP,REM ARM,Q/R 700 LB CAPACITY,REGENCY XL2000
GENDRON, INC.
6728-20-62-78-29-8
Not in Commercial Distribution

  • 00842307100270 ()


  • Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

NA - 00842307100256

WHEELCHAIR,28X20DP,REM ARM,Q/R 700 LB CAPACITY,REGENCY XL2000
GENDRON, INC.
6728-20-62-29-8
Not in Commercial Distribution

  • 00842307100256 ()


  • Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

LEVEL ONE NEURO - 00888118074874

PLATE, LOW PROFILE, Q STYLE, DBL Y, NEURO SCREW, CP TITANIUM
KLS-Martin L.P.
50-312-01-09
In Commercial Distribution

  • 00888118074874 ()

  • 6 HOLE, T=0.6 MM


  • Craniofacial fixation plate, non-bioabsorbable, non-customized

Bio-Eye® - 00854066006045

Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I00024S
In Commercial Distribution

  • 00854066006045 ()

  • Outer Diameter: 24 Millimeter


  • Ophthalmic conformer
  • Orbital sphere implant

Bio-Eye® - 00854066006038

Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I00022S
In Commercial Distribution

  • 00854066006038 ()

  • Outer Diameter: 22 Millimeter


  • Ophthalmic conformer
  • Orbital sphere implant

Bio-Eye® - 00854066006021

Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I00020S
In Commercial Distribution

  • 00854066006021 ()

  • Outer Diameter: 20 Millimeter


  • Ophthalmic conformer
  • Orbital sphere implant

Bio-Eye® - 00854066006014

Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I00018S
In Commercial Distribution

  • 00854066006014 ()

  • Outer Diameter: 18 Millimeter


  • Ophthalmic conformer
  • Orbital sphere implant

Bio-Eye® - 00854066006007

Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I00016S
In Commercial Distribution

  • 00854066006007 ()

  • Outer Diameter: 16 Millimeter


  • Ophthalmic conformer
  • Orbital sphere implant

Optimus Q Long - 09348215061753

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-045
In Commercial Distribution

  • 09348215061753 ()


  • Fluted surgical drill bit, reusable

Artis Q biplane - 04056869009995

No Description
Siemens Healthcare GmbH
10848282
In Commercial Distribution

  • 04056869009995 ()


  • Stationary angiographic x-ray system, digital

Artis Q ceiling - 04056869009988

No Description
Siemens Healthcare GmbH
10848281
In Commercial Distribution

  • 04056869009988 ()


  • Stationary angiographic x-ray system, digital

Artis Q floor - 04056869009971

No Description
Siemens Healthcare GmbH
10848280
In Commercial Distribution

  • 04056869009971 ()


  • Stationary angiographic x-ray system, digital

Custom I Q - D798CIQA0

INDICATIONS FOR USE: Custom IQ™ is intended for use as a chair-side, fast set, no mix chemical cure bonding resin for custom base indirect bonding. This is the Part A of the two part system.
RELIANCE ORTHODONTIC PRODUCTS INC
CIQA
Not in Commercial Distribution

  • D798CIQA0 ()
CIQA

  • Dentine bonding agent/set
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