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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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DBX® - W4184227010T0473

AFT Straight Tube (1/2 Filled)
Musculoskeletal Transplant Foundation, Inc.
227010
In Commercial Distribution

  • W4184227010T0473 ()
227010

  • Bone matrix implant, human-derived

Cora - X0037JJ66L

Cora Menstrual Cup Size 2 (DTC & AMZ)
Cora
10MenstrualCup-S2A
In Commercial Distribution

  • X0037JJ66L ()


  • Menstrual cup, non-latex, reusable

LayZir Disc - D952CM0034

LayZir isc AD98-25-LZ A2
SMART DENTISTRY SOLUTIONS INC.
CM0034S
In Commercial Distribution

  • D952CM0034 ()
CM0034S

  • Dental appliance fabrication material, ceramic

Two Stage Bone Level Implant - D78532508ENGPLS0

3.25mm diameter X 8mm length Engage Plus Bone Level Implant
OCO BIOMEDICAL INC
EngagePlus
In Commercial Distribution

  • D78532508ENGPLS0 ()
32508 Engage Plus

  • Screw endosteal dental implant, two-piece

TSI/ERI Locator Abutment - D785189270

Locator Abutment 3.25mm Diameter .7mm Height
OCO BIOMEDICAL INC
Locator Abutment 3.25mm
In Commercial Distribution

  • D785189270 ()
1892

  • Dental implant suprastructure, permanent, preformed

NA - 00811137010769

Red Cell Freezing Pack 2000 mL. Sterile Fluid Path
FENWAL, INC.
4R2422
Not in Commercial Distribution

  • 10811137010766 ()
  • 00811137010769 ()
  • 0FE04R2422 ()
4R2422

  • Blood/tissue storage/culture container

Transfer Pack - 00811137010738

Transfer Pack Container 600 mL with 8 couplers. Sterile Fluid Path
FENWAL, INC.
4R2027
Not in Commercial Distribution

  • 10811137010735 ()
  • 00811137010738 ()
  • 0FE04R2027 ()
4R2027

  • Blood/tissue storage/culture container

Leukoconnect - 00811137010486

LEUKOCONNECT Pre-Storage Sterile Connect Leukoreduction Set with SEPACELL RS-2000 Filter for Red Blood Cells in Additive Solution. Sterile Fluid Path
FENWAL, INC.
4C4300
Not in Commercial Distribution

  • 10811137010483 ()
  • 00811137010486 ()
  • 0FE04C4300 ()
4C4300

  • Blood transfusion set, non-exchange

NA - 00811137010462

SEPACELL Pre-Storage Leukocyte Reduction Set for Red Cells. Sterile Fluid Path
FENWAL, INC.
4C2300
Not in Commercial Distribution

  • 10811137010469 ()
  • 00811137010462 ()
  • 0FE04C2300 ()
4C2300

  • Blood transfusion set, non-exchange

IDI Dental Implant - D747IDI1060088A1

IDI Implant Fixture 6.0mm x 8.8mm (Practice Building Kit)
AIDI BIOMEDICAL LLC
IDI-1060-088-A
In Commercial Distribution

  • D747IDI1060088A1 ()
IDI-1060-088-A

  • Dental implant system
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