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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EXP C U4-4 LME U5-L5-5 022 hks 345
Gc Orthodontics America Inc.
11/32-2CC5-6338
In Commercial Distribution

  • D78811322CC563381 ()
11/32-2CC5-6338

  • Orthodontic bracket, ceramic
  • Orthodontic bracket, metal
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
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
HX6041/11
In Commercial Distribution

  • 00075020007902 ()


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

  • 00075020007650 ()


  • Basic electric toothbrush
MyCRO Band w/Lining purple
OTTO BOCK HEALTHCARE
24H1=11
In Commercial Distribution

  • 04064409000029 ()


  • Cranial orthosis
Gingival Knife, Goldman-Fox, Double Ended
A. TITAN INSTRUMENTS, INC.
GF 11
In Commercial Distribution

  • 00841685110307 ()


  • Periodontal knife
Spreader, Single Ended
A. TITAN INSTRUMENTS, INC.
D 11
In Commercial Distribution

  • 00841685108731 ()


  • Manual endodontic filling material spreader
FILE HIRSCHFELD, # 5/11, 17 CM
BMT Medizintechnik GmbH
HF-5/11
In Commercial Distribution

  • 04251725218324 ()
HF-5/11

  • Bone curette, 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
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
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
10/11MM DIA., 6CM, STAINLESS STEEL TROCAR GUIDE CONES
ELMED INCORPORATED
52203-10/11
In Commercial Distribution

  • 00842180136847 ()
52203-10/11

  • Laparoscopic multi-instrument access port, reusable
Composite Instrument, Plastic Filling Instrument, Double Ended
A. TITAN INSTRUMENTS, INC.
PFI 11
In Commercial Distribution

  • 00841685104511 ()


  • Dental restoration carver, resin
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
TiAl6V4 ELI sterile
Merete GmbH
2 11
In Commercial Distribution

  • 04048266150011 ()

  • Length: 11 Millimeter
  • Outer Diameter: 2.0 Millimeter
CB30011S

  • Orthopaedic bone screw (non-sliding)
No Description
Merete GmbH
2.0 11
In Commercial Distribution

  • 04048266038241 ()

  • Length: 11 Millimeter
CB30011

  • Orthopaedic bone screw (non-sliding)
No Description
MK-Dent GmbH
LB11/11
In Commercial Distribution

  • 04050546002729 ()


  • Dental drilling system attachment
No Description
MK-Dent GmbH
LB41/11
In Commercial Distribution

  • 04050546002767 ()


  • Dental drilling system attachment
The EZCare Softouch is intended to secure a patient’s tracheostomy tube. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
11" Camouflage
In Commercial Distribution

  • 00812594012457 ()
  • 10812594012454 ()
N9111CO

  • Tracheostomy tube neck holder, single-use
The EZCare Softouch is intended to secure a patient’s tracheostomy tube. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
11" Blue
In Commercial Distribution

  • 00812594012389 ()
  • 10812594012386 ()
N9111BL

  • Tracheostomy tube neck holder, single-use
The EZCare Softouch is intended to secure a patient’s tracheostomy tube. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
11" Tan
In Commercial Distribution

  • 00812594012310 ()
  • 10812594012317 ()
N9111TN

  • Tracheostomy tube neck holder, single-use
The EZCare Softouch is intended to secure a patient’s tracheostomy tube. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
11" Pink
In Commercial Distribution

  • 00812594012242 ()
  • 10812594012249 ()
N9111PK

  • Tracheostomy tube neck holder, single-use
No Description
TEKNIMED
11 CC
Not in Commercial Distribution

  • 03760177046344 ()
183901000

  • Vertebral bone filler, non-bioabsorbable
No Description
TEKNIMED
11 CC
Not in Commercial Distribution

  • 03760177043947 ()
183901000

  • Vertebral bone filler, non-bioabsorbable
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
Articulating Surfaces, PS
WALDEMAR LINK GmbH & Co. KG
880-253/11
In Commercial Distribution

  • 04026575255788 ()
880-253/11

  • Uncoated knee tibia prosthesis, polyethylene
Articulating Surfaces, PS
WALDEMAR LINK GmbH & Co. KG
880-252/11
In Commercial Distribution

  • 04026575255702 ()
880-252/11

  • Uncoated knee tibia prosthesis, polyethylene
Articulating Surfaces, PS
WALDEMAR LINK GmbH & Co. KG
880-251/11
In Commercial Distribution

  • 04026575255641 ()
880-251/11

  • Uncoated knee tibia prosthesis, polyethylene
Articulating Surfaces, CR
WALDEMAR LINK GmbH & Co. KG
880-249/11
In Commercial Distribution

  • 04026575255597 ()
880-249/11

  • Uncoated knee tibia prosthesis, polyethylene
Articulating Surfaces, CR
WALDEMAR LINK GmbH & Co. KG
880-247/11
In Commercial Distribution

  • 04026575255535 ()
880-247/11

  • Uncoated knee tibia prosthesis, polyethylene
Articulating Surfaces, CR
WALDEMAR LINK GmbH & Co. KG
880-245/11
In Commercial Distribution

  • 04026575255474 ()
880-245/11

  • Uncoated knee tibia prosthesis, polyethylene
Articulating Surfaces, CR
WALDEMAR LINK GmbH & Co. KG
880-243/11
In Commercial Distribution

  • 04026575255368 ()
880-243/11

  • Uncoated knee tibia prosthesis, polyethylene
Articulating Surfaces, CR
WALDEMAR LINK GmbH & Co. KG
880-241/11
In Commercial Distribution

  • 04026575255238 ()
880-241/11

  • Uncoated knee tibia prosthesis, polyethylene
Orthopaedic prosthesis instrument, reusable - General Instrument
WALDEMAR LINK GmbH & Co. KG
15-1436/11
In Commercial Distribution

  • 04026575234011 ()


  • Surgical torque wrench, reusable
BiMobile Liner - X-LINKed Vit-E PE (E-Dur)
WALDEMAR LINK GmbH & Co. KG
184-280/11
In Commercial Distribution

  • 04026575230730 ()
184-280/11

  • Constrained polyethylene acetabular liner
Articulating Surfaces, PS+
WALDEMAR LINK GmbH & Co. KG
880-269/11
In Commercial Distribution

  • 04026575256495 ()
880-269/11

  • Uncoated knee tibia prosthesis, polyethylene
Articulating Surfaces, PS+
WALDEMAR LINK GmbH & Co. KG
880-267/11
In Commercial Distribution

  • 04026575256433 ()
880-267/11

  • Uncoated knee tibia prosthesis, polyethylene
Articulating Surfaces, PS+
WALDEMAR LINK GmbH & Co. KG
880-265/11
In Commercial Distribution

  • 04026575256372 ()
880-265/11

  • Uncoated knee tibia prosthesis, polyethylene
Articulating Surfaces, PS+
WALDEMAR LINK GmbH & Co. KG
880-264/11
In Commercial Distribution

  • 04026575256310 ()
880-264/11

  • Uncoated knee tibia prosthesis, polyethylene
Articulating Surfaces, PS+
WALDEMAR LINK GmbH & Co. KG
880-263/11
In Commercial Distribution

  • 04026575256259 ()
880-263/11

  • Uncoated knee tibia prosthesis, polyethylene
Articulating Surfaces, PS+
WALDEMAR LINK GmbH & Co. KG
880-262/11
In Commercial Distribution

  • 04026575256198 ()
880-262/11

  • Uncoated knee tibia prosthesis, polyethylene
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