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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LW, SNAP to DIN, UNSHIELDED, 24", BROW
CURBELL MEDICAL PRODUCTS, INC.
LW-2090024BR
In Commercial Distribution

  • 00840828146944 ()
9192

  • Electrocardiographic lead set, reusable
LW, SNAP TO DIN, UNSHIELDED, 24",GREEN
CURBELL MEDICAL PRODUCTS, INC.
LW-2090024GR
In Commercial Distribution

  • 00840828146937 ()
9193

  • Electrocardiographic lead set, reusable
LW, SNAP to DIN, UNSHIELDED, 24", RED
CURBELL MEDICAL PRODUCTS, INC.
LW-2090024RD
In Commercial Distribution

  • 00840828146920 ()
9194

  • Electrocardiographic lead set, reusable
LW, SNAP to DIN, UNSHIELDED, 24", WHIT
CURBELL MEDICAL PRODUCTS, INC.
LW-2090024WH
In Commercial Distribution

  • 00840828146913 ()
9195

  • Electrocardiographic lead set, reusable
5-LD Set, PINCH to DIN, UNSHIELDED, H,
CURBELL MEDICAL PRODUCTS, INC.
LW-3090040/5A
In Commercial Distribution

  • 00840828146906 ()
9230

  • Electrocardiographic lead set, reusable
SPO2 AD CB, NELCR to SPLABS, ULTRAVIEW8
CURBELL MEDICAL PRODUCTS, INC.
CB-A400-1103A
In Commercial Distribution

  • 00840828146609 ()
5587

  • Electrical-only medical device connection cable, reusable
5-LD ECG CABLE DATEX TO GE LEADS
CURBELL MEDICAL PRODUCTS, INC.
CB-51595R
In Commercial Distribution

  • 00840828146029 ()
5463

  • Electrocardiographic electrode connector
5-LD TWIN TO 001A ECG CABLE, A
CURBELL MEDICAL PRODUCTS, INC.
CB-81540R
In Commercial Distribution

  • 00840828146005 ()
5550

  • Electrocardiographic electrode connector
ADAPTOR,P412(8') & P3701(1') TO S412
CURBELL MEDICAL PRODUCTS, INC.
AD-0223
In Commercial Distribution

  • 00840828133784 ()
15254

  • Electrical mains power extension cable
JUMPER,6",P1010 TO S103 INLINE, WT
CURBELL MEDICAL PRODUCTS, INC.
JU06-622
In Commercial Distribution

  • 00840828133159 ()
15030

  • Electrical mains power extension cable
JUMPER,120",P800 TO P102,BOTH MOLDED
CURBELL MEDICAL PRODUCTS, INC.
JU120-165
In Commercial Distribution

  • 00840828131735 ()
14096

  • Electrical mains power extension cable
JUMPER,300",P800 TO S800,BOTH MECHANIC
CURBELL MEDICAL PRODUCTS, INC.
JU300-100
In Commercial Distribution

  • 00840828129459 ()
8195

  • Electrical mains power extension cable
JUMPER,6",P800 TO S103 INLINE,R4
CURBELL MEDICAL PRODUCTS, INC.
JU06-602
In Commercial Distribution

  • 00840828129183 ()
8135

  • Electrical mains power extension cable
ADP,P3701 TO S3701,S800,RW,FLANGE
CURBELL MEDICAL PRODUCTS, INC.
AD-0626
In Commercial Distribution

  • 00840828127523 ()
16992

  • Electrical mains power extension cable
JUMPER,72",GRAY,P1010 TO S1010,WEST-COM
CURBELL MEDICAL PRODUCTS, INC.
JU72-580
In Commercial Distribution

  • 00840828127493 ()
8426

  • Electrical mains power extension cable
JUMPER,6",GRAY,P1010 TO S1010,WEST-COM
CURBELL MEDICAL PRODUCTS, INC.
JU06-311
In Commercial Distribution

  • 00840828127486 ()
8124

  • Electrical mains power extension cable
JUMPER,12",GRAY,P1010 TO S1010,WEST-COM
CURBELL MEDICAL PRODUCTS, INC.
JU12-200
In Commercial Distribution

  • 00840828127479 ()
8167

  • Electrical mains power extension cable
JUMPER,144",1/4" TO 1/4"
CURBELL MEDICAL PRODUCTS, INC.
JU144-120
In Commercial Distribution

  • 00840828189323 ()
8176

  • Electrical-only medical device connection cable, reusable
JUMPER,PS BREAKAWAY,P808 TO S800,10",SF.
CURBELL MEDICAL PRODUCTS, INC.
JUP-1066-010
In Commercial Distribution

  • 00840828186551 ()
27860

  • Electrical-only medical device connection cable, reusable
JUMPER,120",P103 TO RJ12
CURBELL MEDICAL PRODUCTS, INC.
JU96-811
In Commercial Distribution

  • 00840828195355 ()
30364

  • Electrical mains power extension cable
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
C
In Commercial Distribution

  • 10810190013790 ()
110026903

  • Orthopaedic guidewire, reusable
Used to convert and allow the use of ratchet tools in a dental implant surgery kit.
STERNGOLD DENTAL LLC
905805
In Commercial Distribution

  • 00841549118999 ()


  • Fixture/appliance dental drill bit, reusable
No Description
implantcast GmbH
78200580
In Commercial Distribution

  • 04048844533731 ()


  • Orthopaedic fixation implant alignment tool
No Description
Roche Diagnostics GmbH
5401674190
In Commercial Distribution

  • 04015630926961 ()
5401674190

  • Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry
No Description
Navinetics, Inc.
NN1250
In Commercial Distribution

  • 10850023620177 ()
NN1250

  • Neurological stereotactic surgery system
No Description
LUMENIS LTD.
AcuPulseā„¢ Upgrade Kit 40AES-F to 40AES-A
In Commercial Distribution

  • 07290109142920 ()


  • General/multiple surgical solid-state/carbon dioxide laser system
No Description
LUMENIS LTD.
AcuPulseā„¢ Upgrade Kit 40 to 40ST
In Commercial Distribution

  • 07290109142913 ()


  • General/multiple surgical solid-state/carbon dioxide laser system
No Description
LUMENIS LTD.
AcuPulseā„¢ Upgrade Kit 40 to 40F
Not in Commercial Distribution

  • 07290109142906 ()


  • General/multiple surgical solid-state/carbon dioxide laser system
Additional DM UDI: 07290109144054; 07290109144061; 07290109144047; 07290109144078
LUMENIS LTD.
AcuPulseā„¢ Upgrade Kit 40 to 40AES-R
Not in Commercial Distribution

  • 07290109142890 ()
  • 07290109144122 ()


  • General/multiple surgical solid-state/carbon dioxide laser system
Additional DM UDI: 07290109144054; 07290109144061; 07290109144047; 07290109144122
LUMENIS LTD.
AcuPulseā„¢ Upgrade Kit 40 to 40AES-A
In Commercial Distribution

  • 07290109142883 ()
  • 07290109144078 ()


  • General/multiple surgical solid-state/carbon dioxide laser system
No Description
LUMENIS LTD.
AcuPulseā„¢ Upgrade Kit 30 to 30ST
In Commercial Distribution

  • 07290109142876 ()


  • General/multiple surgical solid-state/carbon dioxide laser system
No Description
LUMENIS LTD.
AcuPulseā„¢ Upgrade Kit 40AES-R To 40AES-A
In Commercial Distribution

  • 07290109142852 ()


  • General/multiple surgical solid-state/carbon dioxide laser system
Additional DM UDI: 07290109144054; 07290109144047; 07290109144078; 07290109144122
LUMENIS LTD.
AcuPulseā„¢ Upgrade Kit 40AES-F to 40AES-R
Not in Commercial Distribution

  • 07290109142845 ()
  • 07290109144061 ()


  • General/multiple surgical solid-state/carbon dioxide laser system
LDW TO PHILIPS 2000 WITH SHOWER SHIELD
CURBELL MEDICAL PRODUCTS, INC.
DLW-05AU-40AS-0000
In Commercial Distribution

  • 90840828154485 ()
  • 90840828154461 ()
  • 90840828154478 ()
20640

  • Electrocardiographic electrode, single-use
LEAD WIRE,PINCH TO NIHON KONDEN,INTERMED
CURBELL MEDICAL PRODUCTS, INC.
DLW-06BF-MXAN-3000
Not in Commercial Distribution

  • 90840828101519 ()
  • 90840828101045 ()
  • 90840828101199 ()
18604

  • Electrocardiographic electrode, single-use
DLW,5LD,SNAP TO MULTI,CHEST,INTERMED
CURBELL MEDICAL PRODUCTS, INC.
DLW-05AM-40AM-3000
Not in Commercial Distribution

  • 90840828101410 ()
  • 90840828101007 ()
  • 90840828101151 ()
18600

  • Electrocardiographic electrode, single-use
LDW TO INTELLIVUE W/SHOWR SHLD,INTERMED
CURBELL MEDICAL PRODUCTS, INC.
DLW-05BU-40AS-3000
Not in Commercial Distribution

  • 90840828101106 ()
  • 90840828100956 ()
18595

  • Electrocardiographic electrode, single-use
Cable, V1-MPC to Electrode – Medtronic/QuickCombo (~10ft)
Tz Medical, Inc.
PAD 6091
In Commercial Distribution

  • 00811331018349 ()


  • Electrical catheter connection cable/switch
Cable, V1-MPC to Defibrillator/Pacemaker – Zoll (~10ft)
Tz Medical, Inc.
PAD 6080
In Commercial Distribution

  • 00811331017502 ()


  • Electrical catheter connection cable/switch
Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
Braebon Medical Corporation
8592A
In Commercial Distribution

  • B1408592A0 ()

  • Length: 48 Inch
8592A

  • Pneumograph
Cable for the Q-RIPā„¢ Respiratory Effort Systemā„¢ which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
Braebon Medical Corporation
0573A
In Commercial Distribution

  • B1400573A0 ()
0573A

  • Electrical-only medical device connection cable, reusable
ISolate Ready to Use Density Gradient Medium at Two Concentrations. Contains 1x100mL Upper Layer and 1x100mL Lower Layer.
IRVINE SCIENTIFIC, LLC
99264-2x100ML
In Commercial Distribution

  • 00810195240361 ()
99264

  • IVF medium
ISolate Ready to Use Density Gradient Medium at Two Concentrations. Contains 6x6mL Upper Layer and 6x6mL Lower Layer.
IRVINE SCIENTIFIC, LLC
99264-12x6ML
In Commercial Distribution

  • 00810195240354 ()
99264

  • IVF medium
No Description
GLOBAL SURGICAL CORPORATION
M 713GU
In Commercial Distribution

  • 00810040251436 ()


  • General-purpose surgical microscope
No Description
GLOBAL SURGICAL CORPORATION
M 528XSLR-NEX
In Commercial Distribution

  • 00810040251009 ()


  • General-purpose surgical microscope
No Description
GLOBAL SURGICAL CORPORATION
M 528XSLR-F
In Commercial Distribution

  • 00810040250996 ()


  • General-purpose surgical microscope
No Description
GLOBAL SURGICAL CORPORATION
M 528XSLR-EOS
In Commercial Distribution

  • 00810040250989 ()


  • General-purpose surgical microscope
No Description
GLOBAL SURGICAL CORPORATION
M A730-GCK
In Commercial Distribution

  • 00810040250767 ()


  • General-purpose surgical microscope
No Description
Bird & Cronin, LLC
08140260
In Commercial Distribution

  • 50610570140980 ()
  • 00610570140985 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
08140345
In Commercial Distribution

  • 50610570002219 ()
  • 00610570002214 ()


  • Abdominal binder, single-use
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