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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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Pin Site Sponge
Os Medica, LLC
950S
In Commercial Distribution

  • 00860011062608 ()
  • 00860011062615 ()
  • 50860011062603 ()
950S

  • Wound-nonadherent dressing, absorbent, non-antimicrobial
No Description
Anthrotronix, Inc.
1.0
In Commercial Distribution

  • 00860011042105 ()


  • Cognitive assessment software
Autoclave pan and tray for Surgical HypoHolder
TyTek Medical Inc.
1009
In Commercial Distribution

  • 00860010987926 ()


  • Instrument tray, reusable
Binder Transfer slide sheet for Stryker Pro XT and Pro 2 models (Sheet only)
We Stitch Stuff, LLC
BT-SS2-BL
In Commercial Distribution

  • 00860010986561 ()
BT-SS2-BL

  • Patient transfer/turning sheet, reusable
Binder Transfer Stryker Bundle (Sheet/Transer-aid with set of 8 anchors)
We Stitch Stuff, LLC
BT-SB1-BL
In Commercial Distribution

  • 00860010986554 ()
BT-SB1-BL

  • Patient transfer/turning sheet, reusable
Cleft Lip Approximation Tape Size Small
Cleftalign Inc.
LAT-S
In Commercial Distribution

  • 00860010953952 ()


  • Skin-closure adhesive strip
Cleft Lip Approximation Tape Size Medium
Cleftalign Inc.
LAT-M
In Commercial Distribution

  • 00860010953945 ()


  • Skin-closure adhesive strip
Cleft Lip Approximation Tape Size Large
Cleftalign Inc.
LAT-L
In Commercial Distribution

  • 00860010953938 ()


  • Skin-closure adhesive strip
Cleft Nose Approximation Device Size # 3
Cleftalign Inc.
NAS 03
In Commercial Distribution

  • 00860010953921 ()


  • Skin-closure adhesive strip
Cleft Nose Approximation Device Size # 2
Cleftalign Inc.
NAS 02
In Commercial Distribution

  • 00860010953914 ()


  • Skin-closure adhesive strip
Cleft Nose Approximation Device Size # 1
Cleftalign Inc.
NAS 01
In Commercial Distribution

  • 00860010953907 ()


  • Skin-closure adhesive strip
No Description
Otc Hearing Inc
HearYou ONE
In Commercial Distribution

  • 00860010946206 ()


  • Air-conduction hearing aid, behind-the-ear
The System 83 RevolveĀ® Endoscope Washer/Disinfector is an automated, computer controlled, electro-mechanical system intended to wash and high-level disinfect one or two submersible flexible endoscopes utilizing a detergent and FDA cleared high-level disinfectant validated by Wassenburg Medical. The System 83 RevolveĀ® utilizes a processing chamber and the immersion method to perform washing, disinfection, rinsing, and alcohol flush of an endoscope to render a high-level disinfected endoscope. The System 83 RevolveĀ® is capable of automated detergent dispensing and transfer of disinfectant solution between the reservoir and processing chamber. Following disinfection, the endoscopes and channels are automatically rinsed with potable water that is filtered through a water filtration system that contains a 0.1 micron bacteria filter and the channels are then flushed with air. A semi-automated air/alcohol flush must be completed at the end of the cycle. At completion, the operator prints out the endoscope reprocess
Wassenburg Medical, Inc.
System 83 Revolve
In Commercial Distribution

  • 00860010835241 ()


  • Endoscope washer-disinfector (chemical)
Mandible And Maxilla Model - 2 Piece
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801697 ()
MAPMANI2P

  • Custom-made organ/bone anatomy model
Screw metal sleeve
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801680 ()
Q-SPTS

  • Custom-made orthopaedic/craniofacial surgical guide
Slot metal sleeve
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801673 ()
Q-SPCS

  • Custom-made orthopaedic/craniofacial surgical guide
Drill metal sleeve
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801666 ()
Q-SPBS

  • Custom-made orthopaedic/craniofacial surgical guide
Genioplasty Surgical Guide - Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801659 ()
GCGTI

  • Custom-made orthopaedic/craniofacial surgical guide
Genioplasty Surgical Guide with dental support - Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801642 ()
GCGSDTI

  • Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801635 ()
GCLTI

  • Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide with dental support - TI
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801628 ()
GCLSDTI

  • Custom-made orthopaedic/craniofacial surgical guide
Genioplasty Surgical Guide with Splint - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801611 ()
GCGFBC

  • Custom-made orthopaedic/craniofacial surgical guide
Genioplasty Surgical Guide - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801604 ()
GCGBC

  • Custom-made orthopaedic/craniofacial surgical guide
02 VINYL HOOD W/OPTICAL WINDOW, NECK RING ASSEMBLY, UNTRIMMED SILICONE NECK SEAL
Amron International, Inc.
8891-03
In Commercial Distribution

  • 00860010778616 ()


  • Oxygen administration hood, adult
02 VINYL HOOD W/OPTICAL WINDOW, NECK RING ASSEMBLY, STRAPS AND UNTRIMMED SILICONE NECK SEAL
Amron International, Inc.
8891-03S
In Commercial Distribution

  • 00860010778609 ()


  • Oxygen administration hood, adult
No Description
PATIENT POSITIONING SYSTEMS, LLC
SPU Bariatric
In Commercial Distribution

  • 00860010693155 ()


  • Inflatable patient transfer sliding mattress, single-use
No Description
PATIENT POSITIONING SYSTEMS, LLC
SPU Large
In Commercial Distribution

  • 00860010693148 ()


  • Inflatable patient transfer sliding mattress, single-use
Regular
PATIENT POSITIONING SYSTEMS, LLC
SPU Regular
In Commercial Distribution

  • 00860010693131 ()


  • Inflatable patient transfer sliding mattress, single-use
No Description
PATIENT POSITIONING SYSTEMS, LLC
Reusable Bariatric
In Commercial Distribution

  • 00860010693124 ()


  • Inflatable patient transfer sliding mattress, reusable
No Description
PATIENT POSITIONING SYSTEMS, LLC
Reusable Large
In Commercial Distribution

  • 00860010693117 ()


  • Inflatable patient transfer sliding mattress, reusable
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