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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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PermaLife Cell Culture bag, 750ml, with SCD Tubing
ORIGEN BIOMEDICAL, INC.
PL750N
In Commercial Distribution

  • 10816203023251 ()
PL750N

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 120ml, with SCD Tubing
ORIGEN BIOMEDICAL, INC.
PL120N
In Commercial Distribution

  • 10816203023244 ()
PL120N

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 325ml, with SCD Tubing
ORIGEN BIOMEDICAL, INC.
PL325N
In Commercial Distribution

  • 10816203023237 ()
PL325N

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 325ml with 10cm sheath
ORIGEN BIOMEDICAL, INC.
PL325M
In Commercial Distribution

  • 10816203023008 ()
PL325M

  • Blood/tissue storage/culture container
Electronic Apex Locator is used to support the dentist in the determination of the working length during the endodontic treatment.
Shenzhen Superline Technology Co., Ltd.
Alpha Apex I
In Commercial Distribution

  • 01069448351999 ()
  • 06944835199918 ()


  • Endodontic apex locator
Expasyl is a paste for temporary gingival retraction that ensures separation of the marginal gingiva and drying of the sulcus
ACTEON MANUFACTURING
EXPASYL EXACT
In Commercial Distribution

  • 03760243001048 ()
  • 03760243007170 ()
  • 03760243007187 ()
  • 03760243007194 ()


  • Gingival retraction kit
PuraPly™ Antimicrobial XT Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial XT Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
ORGANOGENESIS INC.
515-017
In Commercial Distribution

  • 00618474000466 ()

  • Width: 4.91 Centimeter
  • Length: 4.91 Centimeter


  • Animal-derived wound matrix dressing
PuraPly™ Antimicrobial XT Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial XT Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
ORGANOGENESIS INC.
515-036
In Commercial Distribution

  • 00618474000282 ()

  • Width: 9 Centimeter
  • Length: 6 Centimeter


  • Animal-derived wound matrix dressing
BenaCel® Plus Hemostatic Dressing is provided in larger sizes for medical use. Made of biocompatible oxidized cellulose, BenaCel® Plus is intended for the temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.) and traumatic injuries. It may also be used as a topical dressing for local management of bleeding wounds such as lacerations, cuts and abrasions. Approximate resorption time is 2 weeks.
UNICARE BIOMEDICAL INC.
10x20mm
In Commercial Distribution

  • D767B0226101 ()
  • D767B0226100 ()
B02-2610

  • Plant polysaccharide haemostatic agent, bioabsorbable
BenaCel® Plus Hemostatic Dressing is provided in larger sizes for medical use. Made of biocompatible oxidized cellulose, BenaCel® Plus is intended for the temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.) and traumatic injuries. It may also be used as a topical dressing for local management of bleeding wounds such as lacerations, cuts and abrasions. Approximate resorption time is 2 weeks.
UNICARE BIOMEDICAL INC.
10x15mm
In Commercial Distribution

  • D767B0224101 ()
  • D767B0224100 ()
B02-2410

  • Plant polysaccharide haemostatic agent, bioabsorbable
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