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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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AMSure ® Foley Catheters Tray - 10704411014867

2000 mL Drainage Bag Hydrophilic Latex Foley Catheter 5 cc Balloon 16Fr.
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 10704411014867 ()
  • 40704411014868 ()
AS89316H

  • Intermittent urethral drainage catheter, non-antimicrobial, single-use

AMSure ® Foley Catheters Tray - 10704411014850

2000 mL Drainage Bag Hydrophilic Latex Foley Catheter 5 cc Balloon 14Fr.
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411014851 ()
  • 10704411014850 ()
AS89314H

  • Intermittent urethral drainage catheter, non-antimicrobial, single-use

SALVINOSS-B - 00841336112018

SalvinOss®B Bovine Xenograft Bone Graft Material - 1.0 cc 250-1000 microns
SALVIN DENTAL SPECIALTIES, LLC
SALVINOSS-B-SYR-1.00
In Commercial Distribution

  • 00841336112018 ()


  • Dental bone matrix implant, animal-derived

SALVINOSS-B - 00841336112001

SalvinOss®B Bovine Xenograft Bone Graft Material - 0.5 cc 250-1000 microns
SALVIN DENTAL SPECIALTIES, LLC
SALVINOSS-B-SYR-0.50
In Commercial Distribution

  • 00841336112001 ()


  • Dental bone matrix implant, animal-derived

SALVINOSS-B - 00841336111998

SalvinOss®B Bovine Xenograft Bone Graft Material - 0.25 cc 250-1000 microns
SALVIN DENTAL SPECIALTIES, LLC
SALVINOSS-B-SYR-0.25
In Commercial Distribution

  • 00841336111998 ()


  • Dental bone matrix implant, animal-derived

Typenex Wound Drainage - 00812269031301

7 FR Round Perforated, Full, PVC w 400 cc Spring Evacuator + Trocar
TYPENEX MEDICAL LLC
WD0701TK5
In Commercial Distribution

  • 00812269031318 ()
  • 00812269031301 ()


  • Closed-wound drainage kit

Typenex Wound Drainage - 00812269030410

15 FR Round Fluted, Full with Trocar Kit with 100 cc Evacuator
TYPENEX MEDICAL LLC
WD0503TK1
In Commercial Distribution

  • 00812269030427 ()
  • 00812269030410 ()


  • Closed-wound drainage kit

IRRIJET® Single-Use - 60888937015951

IRRIJET® Single-Use WITH SPLATTER-GARD AND 35 CC SYRINGE WOUND IRRIGATION SYSTEM
Coopersurgical, Inc.
55-2134
In Commercial Distribution

  • 30888937015950 ()
  • 20888937015953 ()
  • 60888937015951 ()


  • Irrigation syringe

ZCORE FORM - D765ZF2000

Moldable Collagen-Enriched Porcine Xenograft, Particle Size 0.25-1.0 mm, Sterile, Contents: 2.0 cc
Osteogenics Biomedical Inc
ZF200
In Commercial Distribution

  • D765ZF2000 ()


  • Dental bone matrix implant, animal-derived

ZCORE FORM - D765ZF1000

Moldable Collagen-Enriched Porcine Xenograft, Particle Size 0.25-1.0 mm, Sterile, Contents: 1.0 cc
Osteogenics Biomedical Inc
ZF100
In Commercial Distribution

  • D765ZF1000 ()


  • Dental bone matrix implant, animal-derived
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