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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
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
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
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
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
ADIMS is a stand-alone blood establishment computer software application (BECS) that provides for the management of plasma and whole blood donors for an RBC immunization program as well as the record and inventory management of immunogen red blood cells. The application is used to determine donor eligibility and release of the blood or blood component for transfusion as well as tracking the preparation of immunogen components (vials) for storage and distribution. Additionally, ADIMS allows for the tracking the recipient of transfused immunogen RBCs
Csl Plasma Inc.
1.0
In Commercial Distribution

  • 00860007397615 ()


  • Blood bank information system application software
LOGIC 4.0 is a web-based software application used to support daily operations of product logistics, primarily organizing and controlling the movement of plasma units between facilities such as warehouses and fractionators. The application also communicates observations or post donation information, status and recalls between collection, warehouse and fractionation facilities. LOGIC provides interface capabilities with sub-systems.
Csl Plasma Inc.
4.0
In Commercial Distribution

  • 00860007397608 ()


  • Blood bank information system application software
e-Delphyn LIS 21.x.x (US)
Gpi Usa, Inc.
21.x.x (US)
In Commercial Distribution

  • 00860007282744 ()


  • Blood bank information system
Surround 5.x
Gpi Usa, Inc.
5.x
In Commercial Distribution



  • Blood bank information system
Donor Doc 3.x.x
Gpi Usa, Inc.
3.x.x
In Commercial Distribution



  • Configurable electronic form web-based application software
ElDorado Donor 3.x.x
Gpi Usa, Inc.
3.x.x
In Commercial Distribution



  • Blood bank information system
Regulated Software Application (RSA), Version 2.0 is a stand-alone blood establishment computer software application (BECS) that provides management controls and information services that have been designed to assist personnel in the operation of a blood center.
ARC-ONE SOLUTIONS, LLC
2.0.0.0
In Commercial Distribution

  • 00860006793708 ()
2.0.0.0

  • Blood bank information system application software
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