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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Suspension Sleeve, 12" / 30 cm , 11
Julius Zorn, Inc.
3232DF 11
In Commercial Distribution

  • 00640095025108 ()
02510

  • Tubular support bandage, non-latex, reusable
The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual control during the dilation • the tension on the tissue is visible while passing the stricture, thereby avoiding overstretching • tapered design allowing precise dilation in millimetre increments • reduced procedure time due to less intrument change • evaluation can be done directly after the dilation thanks to the attached transparent cap • two lateral holes for air insufflation and suction • one centered hole for the insertion of a guide wire
Ovesco Endoscopy AG
11/12
In Commercial Distribution

  • 04260206311416 ()
  • 04260206311423 ()
  • 04260206310860 ()

  • mounting depht of the cap: 9 mm
  • for endoscopes with diameter 9.4 - 9.9 mm
  • Length: 27.5 Millimeter
  • Outer plateau diameters: 11 mm / 12 mm
400.32.01

  • Endoscopic gastrointestinal stenosis dilator
Working Sleeve 7,2 mm
Hoogland Spine Products GmbH
1001-ES 11
In Commercial Distribution

  • 04260200310712 ()


  • Endoscope sheath, reusable
FILE HIRSCHFELD, # 5/11, 17 CM
BMT Medizintechnik GmbH
HF-5/11
In Commercial Distribution

  • 04251725218324 ()
HF-5/11

  • Bone curette, reusable
No Description
FEATHER SAFETY RAZOR CO., LTD.
No.11
In Commercial Distribution

  • 04902470026992 ()


  • Scalpel, single-use
No Description
FEATHER SAFETY RAZOR CO., LTD.
No.11
In Commercial Distribution

  • 04902470026084 ()


  • Scalpel, single-use
No Description
FEATHER SAFETY RAZOR CO., LTD.
No.11
In Commercial Distribution

  • 04902470017563 ()


  • Manual scalpel blade, single-use
No Description
SPECWELL CORPORATION
3.8x 11
In Commercial Distribution

  • 04582697820063 ()


  • Indirect monocular ophthalmoscope, electrically-powered
COCR HUMERAL STEM CEMENTED SIZE 6/115MM-STERILE
SYNTHES (U.S.A.) LP
5624-6/11
Not in Commercial Distribution

  • H67956246110 ()
  • 10886982241603 ()
5624611

  • Uncoated shoulder humeral stem prosthesis
TI HUMERAL STEM HA COATED PRESS-FIT SIZE 6/115MM-STERILE
SYNTHES (U.S.A.) LP
5540-6/11
Not in Commercial Distribution

  • H67955406110 ()
  • 10886982241450 ()
5540611

  • Coated shoulder humeral stem prosthesis
TI HUMERAL STEM PRESS-FIT SIZE 6/115MM-STERILE
SYNTHES (U.S.A.) LP
5537-6/11
Not in Commercial Distribution

  • H67955376110 ()
  • 10886982241399 ()
5537611

  • Press-fit shoulder humeral stem prosthesis
No Description
BERNARD CERVOS SOCIETE
11 mm
Not in Commercial Distribution

  • 03760357971084 ()


  • Dental casting non-noble alloy
No Description
BERNARD CERVOS SOCIETE
11 mm
In Commercial Distribution

  • 03760357970209 ()


  • Dental casting non-noble alloy
No Description
Alpinion Medical Systems Co., Ltd.
E-CUBE 11
In Commercial Distribution

  • 08800013523006 ()


  • General-purpose ultrasound imaging system
BSG10/FUS12/MBP20SX/MBP20SX/TRT12NSH
Saeshin Precision Co., Ltd.
SSG10 #11
In Commercial Distribution

  • 08809260475038 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
32:1, Contra Angle(Lever Type) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL-45I
Saeshin Precision Co., Ltd.
X-CUBE #11
In Commercial Distribution

  • 08809260470880 ()


  • Dental power tool system, line-powered
TITAN 11 is a diagnostic DR System that contains high output capacity and high-resolution image processing system. During a surgery, the presence of lesions, size, and location can be recorded easily as Radiography images. The important images can be stored within the device so taking Radiography images is convenient.
GEMSS MEDICAL SYSTEMS CO.,LTD.
TITAN 11
In Commercial Distribution

  • 08809246620032 ()
TITAN 11

  • Computed radiography digital imaging scanner
Water jet flosser
PHILIPS ORAL HEALTHCARE, LLC
HX3801/11
In Commercial Distribution

  • 00075020100399 ()


  • Water jet flosser
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX9994/11
In Commercial Distribution

  • 00075020099396 ()


  • Basic electric toothbrush
No Description
PHILIPS ORAL HEALTHCARE, LLC
BH1021/11
In Commercial Distribution

  • 00075020096845 ()


  • Basic electric toothbrush
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX9990/11
In Commercial Distribution

  • 00075020096289 ()


  • Basic electric toothbrush
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX6481/11
In Commercial Distribution

  • 00075020085627 ()


  • Basic electric toothbrush
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX9944/11
In Commercial Distribution

  • 00075020085221 ()


  • Basic electric toothbrush
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX6827/11
In Commercial Distribution

  • 00075020076137 ()


  • Basic electric toothbrush
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX6857/11
In Commercial Distribution

  • 00075020070418 ()


  • Basic electric toothbrush
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX6853/11
In Commercial Distribution

  • 00075020070371 ()


  • Basic electric toothbrush
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX8072/11
In Commercial Distribution

  • 00075020097569 ()
  • 00075020065926 ()


  • Basic electric toothbrush
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX9924/11
In Commercial Distribution

  • 00075020064448 ()


  • Basic electric toothbrush
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX9903/11
In Commercial Distribution

  • 00075020064370 ()


  • Basic electric toothbrush
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX3631/11
In Commercial Distribution

  • 00075020057969 ()


  • Basic electric toothbrush
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX5911/11
In Commercial Distribution

  • 00075020057129 ()


  • Basic electric toothbrush
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX8332/11
In Commercial Distribution

  • 00075020056252 ()


  • Water jet flosser
No Description
Discus Dental, LLC
DIS350/11
Not in Commercial Distribution

  • 00075020049445 ()


  • Tongue scraper, reusable
No Description
Discus Dental, LLC
DIS251/11
Not in Commercial Distribution

  • 00075020049421 ()


  • Tongue scraper, reusable
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX8341/11
In Commercial Distribution

  • 00075020048202 ()


  • Water jet flosser
No Description
Discus Dental, LLC
DIS359/11
Not in Commercial Distribution

  • 00075020048066 ()


  • Tongue scraper, reusable
No Description
Discus Dental, LLC
DIS357/11
Not in Commercial Distribution

  • 00075020048042 ()


  • Tongue scraper, reusable
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX6041/11
In Commercial Distribution

  • 00075020007902 ()


  • Basic electric toothbrush
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX6031/11
In Commercial Distribution

  • 00075020007650 ()


  • Basic electric toothbrush
EXC 4-4 EXM RH MBT 022/UL 5-5,3,4,5HK
Gc Orthodontics America Inc.
11/19-2CC5-2424
In Commercial Distribution

  • D78811192CC524240 ()
  • D78811192CC524241 ()
11/19-2CC5-2424

  • Orthodontic bracket, ceramic
EXPC RH MBT 022 UL 5-5 U34 L345 HK
Gc Orthodontics America Inc.
11/19-2C45-0020
In Commercial Distribution

  • D78811192C4500200 ()
  • D78811192C4500201 ()
11/19-2C45-0020

  • Orthodontic bracket, ceramic
EXPC U4-4 L3-3/EXMRC U5 L45 ROTH 018 HK
Gc Orthodontics America Inc.
11/19-1CC5-7921
In Commercial Distribution

  • D78811191CC579211 ()
11/19-1CC5-7921

  • Orthodontic bracket, metal
  • Orthodontic bracket, ceramic
EXP C/EXMRC ROTH 018 U/L 5-5 HK 345
Gc Orthodontics America Inc.
11/19-1CC5-1120
In Commercial Distribution

  • D78811191CC511201 ()
11/19-1CC5-1120

  • Orthodontic bracket, metal
  • Orthodontic bracket, ceramic
No Description
DIO Corporation
SHH 11
In Commercial Distribution

  • 08800049204177 ()


  • Surgical instrument handle, non-torque-limiting
No Description
DIO Corporation
AJ3D 11
In Commercial Distribution

  • 08800049418383 ()


  • Dental implant analog
No Description
DIO Corporation
GUIDE 11
In Commercial Distribution

  • 08800049415276 ()


  • Dental guided surgery reference plate
No Description
ORLIMAN S.L.U.
I-112#11
In Commercial Distribution

  • 08435025922150 ()


  • Abdominal hernia truss, reusable
No Description
ORLIMAN S.L.U.
D-111#11
In Commercial Distribution

  • 08435025919709 ()


  • Abdominal hernia truss, reusable
No Description
ORLIMAN S.L.U.
B-110#11
In Commercial Distribution

  • 08435025914841 ()


  • Abdominal hernia truss, reusable
EXPLORER, DE, BRIAULT #11, STD
NORDENT MANUFACTURING INC
EXBRIAULT/11
In Commercial Distribution

  • 00840018605688 ()


  • Dental surgical probe, reusable
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