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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Disposable Nitrile Examination Gloves, Powder Free, 100/Box, Size X-Large
U. S. GLOVE CO., INC.
3273/11
In Commercial Distribution

  • 20731791034571 ()
  • 00731791034577 ()
  • 50731791034572 ()
3273/11

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Latex, Powder Free, Exam, 50/BX Size X-Large
U. S. GLOVE CO., INC.
3418/11
In Commercial Distribution

  • 20731791030269 ()
  • 00731791030265 ()
  • 50731791030260 ()
3418/11

  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
No Description
Joint Jack Company
Joint-Spring 11"
In Commercial Distribution

  • 00858534005073 ()
1254

  • Hand/finger splint, single-use
#10/11 Orban DE File
HU-FRIEDY MFG. CO., LLC
FO10/11
In Commercial Distribution

  • 10889950012458 ()


  • Periodontal file/rasp, manual
#5/11 Hirschfeld DE File
HU-FRIEDY MFG. CO., LLC
FH5/11
In Commercial Distribution

  • 10889950012359 ()


  • Periodontal file/rasp, manual
#23/CP-11 Expro
HU-FRIEDY MFG. CO., LLC
XP23/11
In Commercial Distribution

  • 10889950034771 ()
XP23/11

  • Dental surgical probe, reusable
#9/11 DE Root Canal Plugger
HU-FRIEDY MFG. CO., LLC
RCP9/11
In Commercial Distribution

  • 10889950021160 ()
RCP9/11

  • Endodontic plugger
e-Delphyn Donor version 11.x.x (US)
Gpi Usa, Inc.
11(US)
In Commercial Distribution

  • 00860007282706 ()


  • Blood bank information system
Semi Automatic ESR Analyzer
STERILE SAFEQUIP & CHEMICALS LLP
11.ZE10
In Commercial Distribution

  • 00860011967712 ()
ZE10

  • Erthrocyte sedimentation rate (ESR) analyser IVD
Optical Tracker Snap 11 0.090 IN (previously known as Snap 1)
TrackX Technology, LLC
Snap 11
Not in Commercial Distribution

  • 00860099000806 ()
TX-3-3036

  • Diagnostic x-ray digital imaging system workstation application software
Nellcor-Oximax Compatible DB9 Conn 1.1m
Unimed Medical Supplies, Inc.
OXM.SEN.11
In Commercial Distribution

  • 06936735451395 ()


  • Pulse oximeter probe, reusable
Adult (Color:Red/black/green/yellow)
Unimed Medical Supplies, Inc.
ECG.ELC.11
In Commercial Distribution

  • 06936735487158 ()


  • Electrocardiographic lead set, reusable
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
DIO Corporation
SHH 11
In Commercial Distribution

  • 08800049204177 ()


  • Surgical instrument handle, non-torque-limiting
UPGRADE, SENTINEL 10.5 TO 11.5 OR HIGHER
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129551 ()
040-1766-00

  • Cardiology information system application software
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
VARIAN MEDICAL SYSTEMS, INC.
Channel 11
In Commercial Distribution

  • 00816389028609 ()
  • 10816389028606 ()
Not Sold Separately

  • General-purpose brachytherapy system applicator, remote-afterloading
No Description
TEKNIMED
11 CC
Not in Commercial Distribution

  • 03760177043947 ()
183901000

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

  • 03760177046344 ()
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
No Description
Otto Bock Healthcare Products GmbH
9001C02=11
Not in Commercial Distribution

  • 04032767648788 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Replacement set, CoCrMo, UHMWPE, rotating hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-0037/11
In Commercial Distribution

  • 04026575185313 ()


  • Rotating hinged total knee prosthesis
Femoral component, TiNbN coating, cemented, CoCrMo, UHMWPE, Ti6Al4V, modular, rotating hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-9813/11
In Commercial Distribution

  • 04026575183319 ()


  • Uncoated knee femur prosthesis, metallic
Femoral component, TiNbN coating, cemented, CoCrMo, UHMWPE, Ti6Al4V, modular, rotating hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-9812/11
In Commercial Distribution

  • 04026575183296 ()


  • Uncoated knee femur prosthesis, metallic
Femoral component, TiNbN coating, cemented, CoCrMo, UHMWPE, Ti6Al4V, modular, rotating hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-9811/11
In Commercial Distribution

  • 04026575183272 ()


  • Uncoated knee femur prosthesis, metallic
Femoral component, TiNbN coating, cemented, CoCrMo, UHMWPE, Ti6Al4V, modular, rotating hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-9810/11
In Commercial Distribution

  • 04026575183258 ()


  • Uncoated knee femur prosthesis, metallic
Instrument tray - LCU Hip System
WALDEMAR LINK GmbH & Co. KG
165-100/11
In Commercial Distribution

  • 04026575180684 ()


  • Instrument tray, reusable
Femoral component, cemented, CoCrMo, UHMWPE, Ti6Al4V, modular, pure hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-4833/11
In Commercial Distribution

  • 04026575179282 ()


  • Uncoated knee femur prosthesis, metallic
Femoral component, cemented, CoCrMo, UHMWPE, Ti6Al4V, modular, pure hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-4832/11
In Commercial Distribution

  • 04026575179268 ()


  • Uncoated knee femur prosthesis, metallic
Femoral component, cemented, CoCrMo, UHMWPE, Ti6Al4V, modular, pure hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-4831/11
In Commercial Distribution

  • 04026575179244 ()


  • Uncoated knee femur prosthesis, metallic
Femoral component, cemented, CoCrMo, UHMWPE, Ti6Al4V, modular, pure hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-4830/11
In Commercial Distribution

  • 04026575179220 ()


  • Uncoated knee femur prosthesis, metallic
Femoral component, cemented, CoCrMo, UHMWPE, Ti6Al4V, modular, rotating hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-4813/11
In Commercial Distribution

  • 04026575179206 ()


  • Uncoated knee femur prosthesis, metallic
Femoral component, cemented, CoCrMo, UHMWPE, Ti6Al4V, modular, rotating hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-4812/11
In Commercial Distribution

  • 04026575179183 ()


  • Uncoated knee femur prosthesis, metallic
Femoral component, cemented, CoCrMo, UHMWPE, Ti6Al4V, modular, rotating hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-4811/11
In Commercial Distribution

  • 04026575179169 ()


  • Uncoated knee femur prosthesis, metallic
Femoral component, cemented, CoCrMo, UHMWPE, Ti6Al4V, modular, rotating hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-4810/11
In Commercial Distribution

  • 04026575179145 ()


  • Uncoated knee femur prosthesis, metallic
Articulating Surfaces, PS
WALDEMAR LINK GmbH & Co. KG
880-211/11
In Commercial Distribution

  • 04026575179084 ()
880-211/11

  • Uncoated knee tibia prosthesis, polyethylene
Surgical implant template, reusable - LINK Embrace Shoulder System
WALDEMAR LINK GmbH & Co. KG
630-001/11
In Commercial Distribution

  • 04026575176250 ()


  • Surgical implant template, reusable
BiMobile Liner - conventional UHMWPE
WALDEMAR LINK GmbH & Co. KG
184-260/11
In Commercial Distribution

  • 04026575174775 ()
184-260/11

  • Constrained polyethylene acetabular liner
Knee femur prosthesis trial - Megasystem-C Tumor- and Revision System
WALDEMAR LINK GmbH & Co. KG
16-3195/11
In Commercial Distribution

  • 04026575172368 ()


  • Knee femur prosthesis trial, reusable
Knee femur prosthesis trial - Megasystem-C Tumor- and Revision System
WALDEMAR LINK GmbH & Co. KG
16-3193/11
In Commercial Distribution

  • 04026575172351 ()


  • Knee femur prosthesis trial, reusable
Knee femur prosthesis trial - Megasystem-C Tumor- and Revision System
WALDEMAR LINK GmbH & Co. KG
16-3191/11
In Commercial Distribution

  • 04026575172344 ()


  • Knee femur prosthesis trial, reusable
Rotational Knee Joint Prosthesis
WALDEMAR LINK GmbH & Co. KG
15-3817/11
In Commercial Distribution

  • 04026575164042 ()
15-3817/11

  • Rotating hinged total knee prosthesis
Rotational Knee Joint Prosthesis
WALDEMAR LINK GmbH & Co. KG
15-3818/11
In Commercial Distribution

  • 04026575164028 ()
15-3818/11

  • Rotating hinged total knee prosthesis
Medullary canal orthopaedic reamer, rigid - MP Reconstruction System
WALDEMAR LINK GmbH & Co. KG
134-800/11
In Commercial Distribution

  • 04026575128754 ()


  • Medullary canal orthopaedic reamer, rigid
Medullary canal orthopaedic reamer, rigid - MP Reconstruction System
WALDEMAR LINK GmbH & Co. KG
134-700/11
In Commercial Distribution

  • 04026575128716 ()


  • Medullary canal orthopaedic reamer, rigid
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