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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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Dilator of Uterine Cervix
MEDGYN PRODUCTS, INC.
size 3
In Commercial Distribution

  • M803021003 ()
021003

  • Hygroscopic cervical dilator
dilator of the uterine cervix
MEDGYN PRODUCTS, INC.
size 2
In Commercial Distribution

  • M803021002 ()
021002

  • Hygroscopic cervical dilator
Kit contents: One dilateria, extra thick (6mm), 2 gauze sponge envelopes and IFU
Coopersurgical, Inc.
MX240
In Commercial Distribution

  • 60888937003330 ()
  • 00888937003338 ()

  • Outer Diameter: 6 Millimeter


  • Hygroscopic cervical dilator
discovery® pearl bracket with hook, - 7° Torque, 0° Angulation for tooth 24, McLaughlin-Bennett-Trevisi** 22
DENTAURUM GmbH & Co.KG
722-742-24
In Commercial Distribution

  • J011722742240 ()


  • Orthodontic bracket, ceramic
discovery® pearl bracket with hook, - 7° Torque, 0° Angulation for tooth 24, Roth 22
DENTAURUM GmbH & Co.KG
722-741-24
In Commercial Distribution

  • J011722741240 ()


  • Orthodontic bracket, ceramic
discovery® pearl bracket with hook, - 7° Torque, 0° Angulation for tooth 24, Roth 18
DENTAURUM GmbH & Co.KG
718-741-24
In Commercial Distribution

  • J011718741240 ()


  • Orthodontic bracket, ceramic
discovery® pearl bracket with hook, - 7° Torque, 0° Angulation for tooth 24, McLaughlin-Bennett-Trevisi** 18
DENTAURUM GmbH & Co.KG
718-742-24
In Commercial Distribution

  • J011718742240 ()


  • Orthodontic bracket, ceramic
Curaplex Laryngoscope Set, Blue CASE incl Mac 2-4, Miller 0, 2, 3 and MED Handle
BOUND TREE MEDICAL, LLC
GP126
In Commercial Distribution

  • 00815277029988 ()
GP126

  • First aid kit, non-medicated, single-use
X-MESH EXPANDABLE CAGE SYSTEM EXPANDABLE VERTEBRAL BODY REPLACEMENT, ANTERIOR, LARGE 65 - 90mm, 0/24 DEGREES
Medos International Sàrl
188912565
Not in Commercial Distribution

  • 10705034160580 ()
188912565

  • Metallic spinal interbody fusion cage
X-MESH EXPANDABLE CAGE SYSTEM EXPANDABLE VERTEBRAL BODY REPLACEMENT, ANTERIOR, LARGE 51 - 71mm, 0/24 DEGREES
Medos International Sàrl
188912551
Not in Commercial Distribution

  • 10705034160573 ()
188912551

  • Metallic spinal interbody fusion cage
X-MESH EXPANDABLE CAGE SYSTEM EXPANDABLE VERTEBRAL BODY REPLACEMENT, ANTERIOR, LARGE 40 - 56mm, 0/24 DEGREES
Medos International Sàrl
188912540
Not in Commercial Distribution

  • 10705034160566 ()
188912540

  • Metallic spinal interbody fusion cage
TG Ab QC Kit - Atellica IM - CLT 2 x 3 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995465
In Commercial Distribution

  • 00630414597928 ()
10995465

  • Thyroglobulin antibody IVD, control
TG Ab - Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995464
In Commercial Distribution

  • 00630414597911 ()
10995464

  • Thyroglobulin antibody IVD, control
The alVeo Autologous Fibrin & Platelet System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
ROYAL BIOLOGICS INC.
510354
In Commercial Distribution

  • 10850014593640 ()
  • 00850014593643 ()

  • Total Volume: 60 Milliliter
510354

  • Haematological concentrate system preparation kit, platelet concentration
The SeriVium Autologous Fibrin & Platelet System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
ROYAL BIOLOGICS INC.
510355
In Commercial Distribution

  • 10850014593633 ()
  • 00850014593636 ()

  • Total Volume: 60 Milliliter
510355

  • Haematological concentrate system preparation kit, platelet concentration
The BioIncyte Autologous Fibrin & Platelet System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
ROYAL BIOLOGICS INC.
510356
In Commercial Distribution

  • 10850014593626 ()
  • 00850014593629 ()

  • Total Volume: 60 Milliliter
510356

  • Haematological concentrate system preparation kit, platelet concentration
The Royal MAXX™ BMC concentration system is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of a mixture of peripheral blood and bone marrow aspirate at the patient’s point of care for mixing with autograft and/or allograft bone to improve handling characteristics. The system consists of a kit of consumables including a concentration device, syringes, blunt needle, alcohol wipes, ACD-A anticoagulant, and bone marrow aspiration supplies.
ROYAL BIOLOGICS INC.
MXBMC-60
In Commercial Distribution

  • 00850014593391 ()
  • 10850014593398 ()

  • Total Volume: 60 Milliliter
MXBMC-60

  • Haematological concentrate system preparation kit, platelet concentration
The Royal MAXX™ Accessory Kit is designed for use with the Royal MAXX™ PRP and BMC concentration systems. The kit contains 2 reuseable Royal MAXX Counterbalances and 2 reuseable Turn keys .
ROYAL BIOLOGICS INC.
MXCB
In Commercial Distribution

  • 10850014593381 ()
  • 00850014593384 ()

  • Total Volume: 60 Milliliter
MXCB-1

  • Haematological concentrate system preparation kit, platelet concentration
The Royal MAXX™ PRP concentration system is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient’s point of care for mixing with autograft and/or allograft bone to improve handling characteristics. The system consists of a kit of consumables including a concentration device, syringes, blunt needle, alcohol wipes, ACD-A anticoagulant, and phlebotomy supplies.
ROYAL BIOLOGICS INC.
MXPRP
In Commercial Distribution

  • 10850014593374 ()
  • 00850014593377 ()

  • Total Volume: 60 Milliliter
MXPRP-1

  • Haematological concentrate system preparation kit, platelet concentration
ALBAcyte IgG Sensitized Red Blood Cells for control of the direct and indirect antiglobulin test.
ALBA BIOSCIENCE LIMITED
Z441U
In Commercial Distribution

  • 05060242471162 ()


  • Immunoglobulin-sensitized reagent red blood cell IVD, control
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