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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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Vitale Calcium Alginate Ropes with Antibacterial Silver, 5/box, 10 boxes/case
CELLERA LLC
20500
Not in Commercial Distribution

  • B492205002 ()
  • B492205001 ()
  • B492205000 ()
20500

  • Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Vitale Non-Adhesive Foam Dressings, 4" x 4", 10/box, 10 boxes/case
CELLERA LLC
20444
Not in Commercial Distribution

  • B492204442 ()
  • B492204441 ()
  • B492204440 ()
20444

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
Vitale Foam Heel Dressings, 5/box, 10 boxes/case
CELLERA LLC
20400
In Commercial Distribution

  • B492204002 ()
  • B492204001 ()
  • B492204000 ()
20400

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
Vitale Adhesive Foam Dressing, 6"x6", 10/box, 10 boxes/case
CELLERA LLC
20366
In Commercial Distribution

  • B492203662 ()
  • B492203661 ()
  • B492203660 ()
20366

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
Vitale Adhesive Foam Dressing, 4"x4", 10/box, 10 boxes/case
CELLERA LLC
20344
Not in Commercial Distribution

  • B492203442 ()
  • B492203441 ()
  • B492203440 ()
20344

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
Vitale Silicone Super-Absorbent Dressings, 8" x 10", 10/box, 10 boxes/case
CELLERA LLC
20280
Not in Commercial Distribution

  • B492202803 ()
  • B492202801 ()
  • B492202800 ()
20280

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
Vitale Sacral Silicone Foam Dressing, 7" x 6 3/4", 5/box, 10 boxes/case
CELLERA LLC
20190
Not in Commercial Distribution

  • B492201901 ()
  • B492201900 ()
  • B492201903 ()
20190

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
Vitale Silicone Foam Dressings, 3" X 3", 10/box, 10 boxes/case
CELLERA LLC
20133
Not in Commercial Distribution

  • B492201332 ()
  • B492201331 ()
  • B492201330 ()
20133

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
The Lithotomy Drape (see Figure 1) is a sterile single use device that serves as a sterile barrier for the patient and isolates the surgical site. The Lithotomy Drape also provides a sterile barrier between transurethral and rectal instruments, while also managing fluid collection. The Lithotomy Drape allows the physician to conduct an Aquablation® or other transurethral or transrectal urological procedures and reduce the risk of breaching sterility. The Lithotomy Drape, measuring 105 inches by 53 inches, is made of a Non-woven SMS textile, transparent poly sheeting, and a fluid pouch with a mesh screen.
PROCEPT BIOROBOTICS CORPORATION
351101
In Commercial Distribution

  • B6143511011 ()
  • B6143511018 ()
  • B6143511012 ()
351101

  • Patient surgical drape, single-use
Single use vaginal speculum with built in light source size small
FTT MEDICAL, INC.
140310
In Commercial Distribution

  • B3961403102 ()
  • B3961403100 ()
  • B3961403101 ()
14-0310

  • Vaginal speculum, single-use
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