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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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Techno-Aide - G242TM5R9

Mammography Thyroid Guards - 0.50mm Lead Equivalence-REGULAR LEADED PROTECTIVE MEDIA
Techno-Aide, Inc.
TM-5R
In Commercial Distribution

  • G242TM5R90 ()
  • G242TM5R9 ()
TM-5R

  • Radiation shielding apron

Techno-Aide - G242TM5N9

Mammography Thyroid Guards - 0.50mm Lead Equivalence-LEAD FREE PROTECTIVE MEDIA
Techno-Aide, Inc.
TM-5N
In Commercial Distribution

  • G242TM5N90 ()
  • G242TM5N9 ()
TM-5N

  • Radiation shielding apron

Techno-Aide - G242TM5L9

Mammography Thyroid Guards - 0.50mm Lead Equivalence-LIGHTWEIGHT LEADED PROTECTIVE MEDIA
Techno-Aide, Inc.
TM-5L
In Commercial Distribution

  • G242TM5L90 ()
  • G242TM5L9 ()
TM-5L

  • Radiation shielding apron

Techno-Aide - G242TM3R9

Mammography Thyroid Guards - 0.35mm Lead Equivalence-REGULAR LEADED PROTECTIVE MEDIA
Techno-Aide, Inc.
TM-3R
In Commercial Distribution

  • G242TM3R90 ()
  • G242TM3R9 ()
TM-3R

  • Radiation shielding apron

Techno-Aide - G242TM3N9

Mammography Thyroid Guards - 0.35mm Lead Equivalence-LEAD FREE PROTECTIVE MEDIA
Techno-Aide, Inc.
TM-3N
In Commercial Distribution

  • G242TM3N90 ()
  • G242TM3N9 ()
TM-3N

  • Radiation shielding apron

Techno-Aide - G242TM3L9

Mammography Thyroid Guards - 0.35mm Lead Equivalence-LIGHTWEIGHT LEADED PROTECTIVE MEDIA
Techno-Aide, Inc.
TM-3L
In Commercial Distribution

  • G242TM3L90 ()
  • G242TM3L9 ()
TM-3L

  • Radiation shielding apron

Techno-Aide - G242TH5R9

Mid-Binding Thyroid Guards - 0.50mm Lead Equivalence-REGULAR LEADED PROTECTIVE MEDIA
Techno-Aide, Inc.
TH-5R
In Commercial Distribution

  • G242TH5R90 ()
  • G242TH5R9 ()
TH-5R

  • Radiation shielding apron

Propper Duo-Spore Biological Indicator Growth Media Vials - 30818087012301

Propper Duo-Spore Biological Indicator Growth Media Vials (25/bx)
PROPPER MANUFACTURING COMPANY, INC.
26910700
In Commercial Distribution

  • 10818087012307 ()
  • 30818087012301 ()
26910700

  • Biological sterilization indicator

Resp-O2 Hygroscopic Condenser Humidifier (HMEF) 600 B/V Filter, CO2 Port - 00840117305373

Pediatric, Tidal Volume Range(70-600mL), Media(Foam + Flat Media), Dead Space(19mL), Breathing Resistance(1.6cm H2O at 30L /min), Weight(19g)
Dynarex Corporation
30107
In Commercial Distribution

  • 00840117305380 ()
  • 00840117305373 ()


  • Heat/moisture exchanger/microbial medical gas filter

Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000 CO2 Port, Low Profile - 00840117305311

Adult, Tidal Volume Range( 150-1000mL), Media (Foam+ Flat Media), Dead Space (43mL), Breathing Resistance (1.9cm H2O at 60L /min), Weight (21g)
Dynarex Corporation
30104
In Commercial Distribution

  • 00840117305328 ()
  • 00840117305311 ()


  • Heat/moisture exchanger/microbial medical gas filter

NA - 04260498580002

No Description
TEC COM GmbH, Gesellschaft für Technik, Technologie und Vermarktung
TECOTHERM NEO
In Commercial Distribution

  • 04260498580002 ()


  • External circulating-fluid core temperature regulation system control unit, heating/cooling

Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500 B/V Filter and CO2 Port - 00840117305335

Adult, Tidal Volume Range(250-1500 mL), Media (Foam + Flat Media), Dead Space (60mL), Breathing Resistance (1.8cm H2O at 60L /min), Weight (36g)
Dynarex Corporation
30105
In Commercial Distribution

  • 00840117305342 ()
  • 00840117305335 ()


  • Heat/moisture exchanger/microbial medical gas filter

Radiation Planning Assistant (RPA) - 00040695000008

The Radiation Planning Assistant (RPA) is a web-based contouring and radiotherapy treatment planning software tool that incorporates the basic radiation planning functions from automated contouring, automated planning with dose optimization, and quality control checks. The system is intended for use for patients with cancer of the head and neck, cervix, breast, and metastases to the brain. The RPA system is integrated with the Eclipse Treatment Planning System v15.6 software cleared under K181145. The RPA radiation treatment planning software tool was trained against hundreds / thousands of CT Scans of normal and diseased tissues from patients receiving radiation for head and neck, cervical, breast, and whole brain at MD Anderson Cancer Center.
The University of Texas M. D. Anderson Cancer Center
1.0.0.5
In Commercial Distribution

  • 00040695000008 ()


  • Radiation therapy software

Biotem - 08800036204159

Biotem IR COM OCTA ABUTMENT 6.0 mm (D) X 2.9 (Octa) x 7.0 mm (H)
Biotem Co., ltd
SAITB607EW
In Commercial Distribution

  • 08800036204159 ()


  • Dental implant system

Biotem - 08800036204142

Biotem IR COM OCTA ABUTMENT 6.0 mm (D) X 2.9 (Octa) x 5.5 mm (H)
Biotem Co., ltd
SAITB605EW
In Commercial Distribution

  • 08800036204142 ()


  • Dental implant system

Biotem - 08800036204135

Biotem IR COM OCTA ABUTMENT 6.0 mm (D) X 2.9 (Octa) x 4.0 mm (H)
Biotem Co., ltd
SAITB604EW
In Commercial Distribution

  • 08800036204135 ()


  • Dental implant system

Biotem - 08800036204128

Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 2.9 (Octa) x 7.0 mm (H)
Biotem Co., ltd
SAITB40437
In Commercial Distribution

  • 08800036204128 ()


  • Dental implant system

Biotem - 08800036204111

Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 2.9 (Octa) x 5.5 mm (H)
Biotem Co., ltd
SAITB40435
In Commercial Distribution

  • 08800036204111 ()


  • Dental implant system

Biotem - 08800036204104

Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 2.9 (Octa) x 4.0 mm (H)
Biotem Co., ltd
SAITB40434
In Commercial Distribution

  • 08800036204104 ()


  • Dental implant system

Biotem - 08800036204098

Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 3.1 (Octa) x 7.0 mm (H)
Biotem Co., ltd
SAIT40437
In Commercial Distribution

  • 08800036204098 ()


  • Dental implant system

Biotem - 08800036204081

Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 3.1 (Octa) x 5.5 mm (H)
Biotem Co., ltd
SAIT40435
In Commercial Distribution

  • 08800036204081 ()


  • Dental implant system

Biotem - 08800036204074

Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 3.1 (Octa) x 4.0 mm (H)
Biotem Co., ltd
SAIT40434
In Commercial Distribution

  • 08800036204074 ()


  • Dental implant system

NORDENT MANUFACTURING INC - 00840018624115

SCALER, DOUBLE END,UNIVERSITY OF SOUTHERN CALIFORNIA #3-4, XDURA DURALITE ROUND HANDLE
NORDENT MANUFACTURING INC
RENSUSC3-4
In Commercial Distribution

  • 00840018624115 ()


  • Manual dental scaler, reusable

NORDENT MANUFACTURING INC - 00840018623132

SCALER, DOUBLE END, TRADE IN, UNIVERSITY OF TEXAS #107-108, #6 RELYANT HANDLE
NORDENT MANUFACTURING INC
TSCUT107-108
In Commercial Distribution

  • 00840018623132 ()


  • Manual dental scaler, reusable

Integra® Miltex® - 10381780258018

University of Texas 22 Instrument Cassette with One Color Color Code Rack
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3118122UTX
Not in Commercial Distribution

  • H8343118122UTX1 ()
  • 10381780258018 ()
3118122UTX

  • Device sterilization/disinfection container, reusable

Composi-Tight® - 00810038096193

3D University Kit: (20) M-Series Matrices, (1) G100 G-Ring, (1) 3D500 Ring
GARRISON DENTAL SOLUTIONS, L.L.C.
UN11
In Commercial Distribution

  • 00810038096193 ()
UN11

  • Dental matrix band kit

Novo Surgical Inc. - 00842331142017

university of minnesota cheek retractor & tounge depressor, 5 1/2" (14.0 cm)
NOVO SURGICAL, INC.
E8313-21
In Commercial Distribution

  • 00842331142017 ()
E8313-21

  • Hand-held surgical retractor, single-use

devemed - 04061644037919

Cheek retractor | 135 mmCheek retractor | 150 mm "University of Cawood-Minnesota" saw edge
devemed GmbH
998-22
In Commercial Distribution

  • 04061644037919 ()


  • Hand-held dental retractor

Aero-Med - 10885380198984

Kit Blood Culture 23G with Sterile Tube for Indiana University Health Only
AERO-MED, LLC
CA54525
In Commercial Distribution

  • 50885380198982 ()
  • 10885380198984 ()
CA54525

  • Phlebotomy kit

Aero-Med - 10885380175237

Bone Marrow Lab Kit, St. Luke's University Health Network, Bethlehem PA Only
AERO-MED, LLC
CA23450
In Commercial Distribution

  • 50885380175235 ()
  • 10885380175237 ()
CA23450

  • Specimen mailer kit

Aero-Med - 10885380175220

Bodily Fluid Collection Kit, St Luke's University Health Network, Bethlehem PA Only
AERO-MED, LLC
CA23425
In Commercial Distribution

  • 50885380175228 ()
  • 10885380175220 ()
CA23425

  • General specimen collection kit

Aero-Med - 10885380174964

Blood Culture Collection Kit, Greater than 14DO28GA, The Ohio State University Only
AERO-MED, LLC
CA26075
Not in Commercial Distribution

  • 50885380174962 ()
  • 10885380174964 ()
CA26075

  • Phlebotomy kit

Aero-Med - 10885380174940

Blood Culture Collection Kit, Less than 14DO28GA, The Ohio State University Only
AERO-MED, LLC
CA23900
Not in Commercial Distribution

  • 50885380174948 ()
  • 10885380174940 ()
CA23900

  • Phlebotomy kit

Novo Surgical - G586E98313210

zenith university of minnesota cheek retractor & tongue depressor, 5-1/2" (14.0 cm)
NOVO SURGICAL, INC.
E98313-21
In Commercial Distribution

  • G586E98313210 ()
E98313-21

  • Hand-held surgical retractor, reusable

Novo Surgical Inc. - 00842331133282

vanderbilt university vessel clamp, horizontal serrations, curved, 8 1/2" (21.5 cm)
NOVO SURGICAL, INC.
G6561-12
In Commercial Distribution

  • 00842331133282 ()
G6561-12

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable

SCHWERT - E8963302040

universal curette CU 4R/4L Culumbia University for maxillay and mandibular posterior
A. Schweickhardt GmbH & Co. KG
3302-04
In Commercial Distribution

  • E8963302040 ()
3302-04

  • Periodontal curette

OC-Auto - 00816917025025

Personal Use Kit OC-Auto, for University of Colorado Health Memorial Hospital Central
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-UCHM
In Commercial Distribution

  • 00816917025025 ()


  • Faecal occult blood IVD, reagent

OC-Auto - 00816917026848

OC-Auto SENSOR io Personal Use Kit, custom kit for University of VT
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPUIO-UVM1
In Commercial Distribution

  • 00816917026848 ()


  • Faecal occult blood IVD, reagent

HELMUT ZEPF - EZPF2420704CTI0

UNIV. CURETTE PERIODONT., ZEPF-BIONIK COLUMBIA UNIVERSITY FIG.4R/4L, BLUE INSERTS INTERCHANGEABLE
Helmut Zepf Medizintechnik GmbH
24.207.04C-TI
In Commercial Distribution

  • EZPF2420704CTI0 ()
24.207.04C-TI

  • Periodontal curette

NORDENT MANUFACTURING INC - 00840018624801

SCALER, DOUBLE END, UNIVERSITY OF SOUTHERN CALIFORNIA #3-4, XDURA DURALITE ROUND HANDLE
NORDENT MANUFACTURING INC
TRNSUSC3-4
In Commercial Distribution

  • 00840018624801 ()


  • Manual dental scaler, reusable
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