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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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PowerHeal 3-layer clear adhesive, 2.3 x 3.5
Vomaris Wound Care, Inc.
2.3" x 3.5"
In Commercial Distribution

  • 00810198031522 ()

  • Length: 2.3 Inch
  • Width: 3.5 Inch
PFK-2335

  • Bioelectric wound dressing
Procellera Single Layer Rx, 5" x 5"
Vomaris Wound Care, Inc.
5" x 5"
In Commercial Distribution

  • 00894318002579 ()
  • 00810198030808 ()
  • 00810198030815 ()
VSR-0505

  • Bioelectric wound dressing
Procellera Single Layer OTC, 4"x 4"
Vomaris Wound Care, Inc.
4" x 4"
In Commercial Distribution

  • 00810198030389 ()
VSC-0404

  • Bioelectric wound dressing
Procellera Single Layer OTC, 2"x2"
Vomaris Wound Care, Inc.
2"x 2"
In Commercial Distribution

  • 00810198030372 ()
VSC-0202

  • Bioelectric wound dressing
Procellera Single Layer Rx 12" x 12"
Vomaris Wound Care, Inc.
12" x 12"
In Commercial Distribution

  • 00810198030358 ()
  • 00810198030310 ()
  • 00810198030365 ()
VSR-1212

  • Portable pneumatic high-frequency ventilator
Procellera Single Layer Rx 8" x 8"
Vomaris Wound Care, Inc.
8" X 8"
In Commercial Distribution

  • 00810198030327 ()
  • 00810198030303 ()
  • 00810198030334 ()
  • 00810198030341 ()
VSR-0808

  • Bioelectric wound dressing
Procellera Single Layer Rx, 4" x 8"
Vomaris Wound Care, Inc.
4" x 8"
In Commercial Distribution

  • 00810198030013 ()
  • 10810198030010 ()
VSR-0408

  • Bioelectric wound dressing
For calibrating the quantitative Direct Total Iron-Binding Capacity (TIBC) assay on automated chemistry analyzer systems. Using the Direct TIBC reagents, measurement of the total iron-binding capacity of serum occurs in a fully automated manner, without the need for any off-line separation. Since the entire reaction process is monitored by the chemistry analyzer, it is necessary to calibrate the assay with serum-based calibrators which are carried through the same reaction process as the patient specimens.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
2 x 2mL
In Commercial Distribution

  • 00812137012173 ()
  • 00812137012463 ()
502-157

  • Total iron binding capacity (TIBC) IVD, calibrator
The CRP Calibrator Set is intended to be used for the calibration of the CDS CRP Reagents. For in vitro diagnostic use only. The calibrators in this kit contain known quantities of human C-reactive protein. These reagents are to be used as calibrators with the manufacturer’s CRP Reagents.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
5 x 2mL
In Commercial Distribution

  • 00812137012142 ()
  • 00812137012432 ()
502-154

  • C-reactive protein (CRP) IVD, calibrator
The Chemistry Control Level I is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly of interest in a general chemistry control, including common drugs and thyroids. For in vitro diagnostic use only. The quality control material is prepared from human serum with enzymes, nonprotein constituents, non-human protein, and bacteriostatic agents added.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
10 x 5mL
In Commercial Distribution

  • 00812137012128 ()
  • 00812137012388 ()
502-152

  • Multiple-type clinical chemistry analyte profile IVD, control
CDS Hematology Calibrator is manufactured for calibration of multi-parameter hematology analyzers for WBC, RBC, Hgb, MCV, Plt and MPV, as applicable to the analyzer system. Multi-parameter hematology analyzers require periodic calibration in order to produce accurate results on patient samples. Calibration may be accomplished by transferring calibration factors to the analyzer through fresh blood samples that have been assayed by reference methods. However, a more direct and convenient approach is to use a calibrator material such as CDS Hematology Calibrator, having system-specific assigned values, derived from a carefully calibrated analyzer or group of analyzers. CDS Hematology Calibrator assigned values are derived from replicate analyses on whole blood calibrated hematology analyzers (see reference procedures). Replicate analyses are performed on the user’s analyzer and calibration factors are computed by comparing recovered values and assigned values. The CDS Hematology Calibrator values are then divided by these determined factors to provide calibration settings for making adjustments to the instrument. Hct, MCH, MCHC, RDW and the WBC differential parameters do not require calibration.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
1 x 4.5mL
In Commercial Distribution

  • 00812137010421 ()
502-068

  • Full blood count IVD, calibrator
24 x 65 Metaphyseal Stem
SIGNAL MEDICAL CORPORATION
24 x 65
In Commercial Distribution

  • B04622051024650 ()
22-05-102465

  • Knee femur stem prosthesis
22 x 60 Metaphyseal Stem
SIGNAL MEDICAL CORPORATION
22 x 60
In Commercial Distribution

  • B04622051022600 ()
22-05-102260

  • Knee femur stem prosthesis
20 x 55 Metaphyseal Stem
SIGNAL MEDICAL CORPORATION
20 x 55
In Commercial Distribution

  • B04622051020550 ()
22-05-102055

  • Knee femur stem prosthesis
Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 18mm High x 56mm Diameter R33mm Articulation.
Shoulder Innovations, Inc.
18mm x 56mm
In Commercial Distribution

  • B1132N2HE180561 ()
2N12HE18056

  • Total shoulder prosthesis
Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 18mm High x 52mm Diameter R30mm Articulation.
Shoulder Innovations, Inc.
18mm x 52mm
In Commercial Distribution

  • B1132N2HE180521 ()
2N2HE18052

  • Total shoulder prosthesis
Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 18mm High x 48mm Diameter R26mm Articulation.
Shoulder Innovations, Inc.
18mm x 48mm
In Commercial Distribution

  • B1132N2HE180481 ()
2N2HE18048

  • Total shoulder prosthesis
Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 18mm High x 46mm Diameter R25mm Articulation.
Shoulder Innovations, Inc.
18mm x 46mm
In Commercial Distribution

  • B1132N2HE180460 ()
2N2HE18046

  • Total shoulder prosthesis
Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 18mm High x 44mm Diameter R23mm Articulation.
Shoulder Innovations, Inc.
18mm x 44mm
In Commercial Distribution

  • B1132N2HE180441 ()
2N2HE18044

  • Total shoulder prosthesis
Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 18mm High x 40mm Diameter R21 Articulation
Shoulder Innovations, Inc.
18mm x 40mm
In Commercial Distribution

  • B1132N2HE180401 ()
2N2HE18040

  • Total shoulder prosthesis
Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 17mm High x 44mm Diameter R24mm Articulation.
Shoulder Innovations, Inc.
17mm x 44mm
In Commercial Distribution

  • B1132N2HE170440 ()
2N2HE17044

  • Total shoulder prosthesis
Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 16mm High x 42mm Diameter R23mm Articulation.
Shoulder Innovations, Inc.
16mm x 42mm
In Commercial Distribution

  • B1132N2HE160420 ()
2N2HE16042

  • Total shoulder prosthesis
Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 15mm High x 52mm Diameter R34mm Articulation.
Shoulder Innovations, Inc.
15mm x 52mm
In Commercial Distribution

  • B1132N2HE150521 ()
2N2HE15052

  • Total shoulder prosthesis
Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 15mm High x 48mm Diameter R30mm Articulation.
Shoulder Innovations, Inc.
15mm x 48mm
In Commercial Distribution

  • B1132N2HE150481 ()
2N2HE15048

  • Total shoulder prosthesis
Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 15mm High x 44mm Diameter R26mm Articulation.
Shoulder Innovations, Inc.
15mm x 44mm
In Commercial Distribution

  • B1132N2HE150441 ()
2N2HE15044

  • Total shoulder prosthesis
Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 15mm High x 40mm Diameter R22mm Articulation.
Shoulder Innovations, Inc.
15mm x 40mm
In Commercial Distribution

  • B1132N2HE150401 ()
2N2HE15040

  • Total shoulder prosthesis
Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 14mm High x 38mm Diameter R21mm Articulation.
Shoulder Innovations, Inc.
14mm x 38mm
In Commercial Distribution

  • B1132N2HE140381 ()
2N2HE14038

  • Total shoulder prosthesis
Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 21mm x 56mm
Shoulder Innovations, Inc.
21mm x 56mm
In Commercial Distribution

  • B1132N1HE210560 ()
2N1HE21056

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 21mm x 52mm.
Shoulder Innovations, Inc.
21mm x 52mm
In Commercial Distribution

  • B1132N1HE210520 ()
2N1HE21052

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 21mm x 50mm
Shoulder Innovations, Inc.
21mm x 50mm
In Commercial Distribution

  • B1132N1HE210500 ()
2N1HE21050

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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