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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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Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-075/40
In Commercial Distribution

  • 04026575240692 ()
645-075/40

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-075/35
In Commercial Distribution

  • 04026575240685 ()
645-075/35

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-075/30
In Commercial Distribution

  • 04026575240678 ()
645-075/30

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-075/25
In Commercial Distribution

  • 04026575240661 ()
645-075/25

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-075/20
In Commercial Distribution

  • 04026575240654 ()
645-075/20

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-073/40
In Commercial Distribution

  • 04026575240647 ()
645-073/40

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-073/35
In Commercial Distribution

  • 04026575240630 ()
645-073/35

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-073/30
In Commercial Distribution

  • 04026575240579 ()
645-073/30

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-073/25
In Commercial Distribution

  • 04026575240524 ()
645-073/25

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-073/20
In Commercial Distribution

  • 04026575240517 ()
645-073/20

  • Orthopaedic bone screw (non-sliding)
OR CLN UP KIT VAN MERT CO HOSP
MEDLINE INDUSTRIES, INC.
DYK1016081C2
In Commercial Distribution

  • 10884389349045 ()
DYK1016081C2

  • General surgical procedure kit, non-medicated, reusable
Widal & Weil Felix Positive control Salmonella Paratyphi C-O
PRO-LAB, INCORPORATED
PLA585
In Commercial Distribution

  • 00817978025856 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent
Salmonella Paratyphi C-O Widal and Weil Felix Antigen
PRO-LAB, INCORPORATED
PLA303
In Commercial Distribution

  • 00817978023036 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-075/60
In Commercial Distribution

  • 04026575302253 ()
645-075/60

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-075/50
In Commercial Distribution

  • 04026575302239 ()
645-075/50

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-073/60
In Commercial Distribution

  • 04026575302215 ()
645-073/60

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-073/50
In Commercial Distribution

  • 04026575302192 ()
645-073/50

  • Orthopaedic bone screw (non-sliding)
4617 @ARTSPC CAN SET W/DISTAL HOLES & CO
MEDLINE INDUSTRIES, INC.
4617R
In Commercial Distribution

  • 20888277374208 ()
  • 10888277374201 ()
4617R

  • Laparoscopic access cannula, reprocessed
357.404 @TAPERED DRL BIT CANTED LG QK CO
MEDLINE INDUSTRIES, INC.
357404RH
In Commercial Distribution

  • 10888277356160 ()
357404RH

  • Cannulated surgical drill bit, single-use
CM-hex screw system Cap screw CO M1.2 short
Cendres+Métaux SA
05000120
In Commercial Distribution

  • 07640166514961 ()
05000120

  • Dental prosthesis/implant abutment screw
Personal Use Kit OC-Auto, for Grand Junction, CO
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 2334490
In Commercial Distribution

  • 00816917022222 ()


  • Faecal occult blood IVD, reagent
CM-hex screw system Cap screw CO M1.4 short
Cendres+Métaux SA
05000122
In Commercial Distribution

  • 07640173090076 ()

  • Length: 6.20 Millimeter
05000122

  • Dental prosthesis/implant abutment screw
KUP5 KOIS UNIV CO (M) FL CP 3P
Peter Brasseler Holdings, LLC
5030933U0
In Commercial Distribution

  • 00887919965077 ()


  • Dental abrasive point, reusable
A portable, non-invasive cardiac output (CO) monitoring device.
CHEETAH MEDICAL (ISRAEL) LTD
CMM-ST5
Not in Commercial Distribution

  • 07290013030030 ()
CMM-ST5

  • Multiple vital physiological parameter monitoring system, clinical
Co. Cr. Base Plastic Castable Abut, Pl.+Co.Cr.
NORIS MEDICAL LTD
NM-C2002
Not in Commercial Distribution

  • 07290108816457 ()
NM-C2002

  • Dental implant suprastructure, temporary, preformed, single-use
*Custom* Wilkes Co IV Start Kit with Saline
BOUND TREE MEDICAL, LLC
8600-01363
In Commercial Distribution

  • 00812277033076 ()
  • 00810094572914 ()
8600-01363

  • Peripheral intravenous catheterization support kit
Magnetic coil for he Axilum Robotics’ TMS-Cobot TS MV solution (K182768) which is an accessory to the predicate MagVenture TMS Therapy System (K150641, K171481 and K171967).
Tonica Elektronik A/S
Cool-B65 CO
In Commercial Distribution

  • 05713484020437 ()
9016E0151

  • Magnetic neural stimulation system
No Description
PHILIPS ORAL HEALTHCARE, LLC
PAL109/CO
In Commercial Distribution

  • 00075020102300 ()


  • Basic electric toothbrush
BUR TWIST 27MM .45HD 4CL CONTRA ANGLE
ACE SURGICAL SUPPLY CO., INC.
502700045
In Commercial Distribution

  • 00614950026708 ()

  • Length: 27 Millimeter
502700045

  • Carbide dental bur, reusable
CONTRA ANGLE DRIVER FOR 5.0MM TRI-CAM SYSTEM SS 17-4 (H900)
ACE SURGICAL SUPPLY CO., INC.
04977901
In Commercial Distribution

  • 00614950009633 ()

  • Length: 27 Millimeter
04977901

  • Orthopaedic implant driver
CONTRA ANGLE DRIVER FOR 4.3MM TRI-CAM SYSTEM SS 17-4 (H900)
ACE SURGICAL SUPPLY CO., INC.
04977701
In Commercial Distribution

  • 00614950009626 ()

  • Length: 27 Millimeter
04977701

  • Orthopaedic implant driver
ONE PIECE CONNECTION TO THE CONTRA ANGLE FOR 3HD 27TL
ACE SURGICAL SUPPLY CO., INC.
04974101
In Commercial Distribution

  • 00614950021277 ()

  • Length: 27 Millimeter
04974101

  • Dental power tool converter attachment, rotary
MOSS VRS Locking Cap Inserter, star 27, AO coupling
Biedermann Motech GmbH & Co. KG
208-010-0205
In Commercial Distribution

  • 04250869634724 ()
208-010-0205

  • General internal orthopaedic fixation system implantation kit
TUMBLER 7OZ STAINLESS STEEL 2-7/8"X 3-1/8"
ACE SURGICAL SUPPLY CO., INC.
0531006
In Commercial Distribution

  • 00614950021840 ()
0531006

  • Medicine cup, reusable
2-channel (4 electrodes) Component of Narcotrend-Compact M (Primary DI Number: 04260497021063)
MT MonitorTechnik GmbH & Co. KG
PKM4
In Commercial Distribution

  • 04260497025016 ()


  • Electroencephalographic monitoring system
1-channel (3 electrodes) Component of Narcotrend-Compact M (Primary DI Number: 04260497021063)
MT MonitorTechnik GmbH & Co. KG
PKM1
In Commercial Distribution

  • 04260497025009 ()


  • Electroencephalographic monitoring system
Product Name: PEAKOSIL Monophase Regular Set This product has another model number, NS024C.
NEOSIL Co., Ltd
MSRC
In Commercial Distribution

  • 18800026400025 ()
  • 08800026400028 ()
  • 08800026400349 ()


  • Silicone dental impression material
CT Bed Rail Mount, Siemens Alt
NEUWAVE MEDICAL, INC.
CTBKT4
In Commercial Distribution

  • 00853719006487 ()

  • Depth: 88 Millimeter
  • Width: 645 Millimeter
CTBKT4

  • Microwave ablation system generator
Sterile Drape for MCM 2-Tier Back Table, 30 x 60" with upper shelf, 12 per case. Single use only.
MID CENTRAL MEDICAL CORP.
MCM555-DRAPE
In Commercial Distribution

  • 00810030863441 ()
  • 10810030863448 ()

  • Width: 50 Inch
  • Length: 88 Inch
MCM555-DRAPE

  • Medical equipment/instrument drape, single-use
No Description
TORNIER
DWF712C
In Commercial Distribution

  • 03700386945335 ()

  • Size 2C
  • Length: 88 Millimeter
  • Angle: 137.5 degree


  • Total reverse shoulder prosthesis
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