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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AS-323 BRU, PEA, and BBE/LKV Convenience Pack - Includes 1 Brucella Blood Agar (BRU), 1 Phenylethyl Alcohol Blood Agar (PEA), and 1 Bacteroides Bile Esculin Agar (BBE)/Laked Brucella Blood Agar with Kanamycin and Vancomycin (LKV) Biplate. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. BRU is opaque burgundy red. PEA is opaque red. BBE is transparent yellow/green. LKV is transparent red. 3 plates per pack.
ANAEROBE SYSTEMS
AS-323
In Commercial Distribution

  • 00810048901326 ()
AS-323

  • Multiple formulation agar culture medium IVD
AS-322 BRU and BBE/PEA Convenience Pack - Includes 1 Brucella Blood Agar (BRU) and 1 Bacteroides Bile Esculin Agar (BBE)/Phenylethyl Alcohol Blood Agar (PEA) Biplate. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. BRU is opaque burgundy red. BBE is transparent yellow/green. PEA is opaque red. 2 plates per pack.
ANAEROBE SYSTEMS
AS-322
In Commercial Distribution

  • 00810048901319 ()
AS-322

  • Multiple formulation agar culture medium IVD
AS-303 BRU, PEA, and LKV Convenience Pack - Includes 1 Brucella Blood Agar (BRU), 1 Phenylethyl Alcohol Blood Agar, and 1 Laked Brucella Blood Agar with Kanamycin and Vancomycin (LKV). Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. BRU is opaque burgundy red. PEA is opaque red. LKV is transparent red. 3 plates per pack.
ANAEROBE SYSTEMS
AS-303
In Commercial Distribution

  • 00810048901302 ()
AS-303

  • Multiple formulation agar culture medium IVD
AS-302 BRU and BBE/LKV Convenience Pack - Includes 1 Brucella Blood Agar (BRU) and 1 Bacteroides Bile Esculin Agar (BBE)/Laked Brucella Blood Agar with Kanamycin and Vancomycin (LKV) Biplate. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. BRU is opaque burgundy red. BBE is transparent yellow/green. LKV is transparent red. 2 plates per pack.
ANAEROBE SYSTEMS
AS-302
In Commercial Distribution

  • 00810048901296 ()
AS-302

  • Multiple formulation agar culture medium IVD
No Description
MASIMO CORPORATION
1853
In Commercial Distribution

  • 00843997001380 ()


  • Electrical-only medical device connection cable, reusable
No Description
MASIMO CORPORATION
1810
In Commercial Distribution

  • 00843997001359 ()


  • Electrical-only medical device connection cable, reusable
Explorer # D11/12A "Old Dominion University Large" COMFORT | SL | double ended
devemed GmbH
02-1446-21 C
In Commercial Distribution

  • 04061644035168 ()


  • Dental surgical probe, reusable
Explorer # D11/12A "Old Dominion University Large" F-LINE | SL | double ended
devemed GmbH
1446-21 F
In Commercial Distribution

  • 04061644022540 ()


  • Dental surgical probe, reusable
SCALER, DOUBLE END, UNIVERSITY OF SOUTHERN CALIFORNIA #3-4, #6 RELYANT HANDLE
NORDENT MANUFACTURING INC
VSCUSC3-4
In Commercial Distribution

  • 00840018621503 ()


  • Manual dental scaler, reusable
CURETTE, DOUBLE END, UNIVERSITY OF CALIFORNIA RULE #3-4, #6 RELYANT HANDLE
NORDENT MANUFACTURING INC
VSCUC3-4
In Commercial Distribution

  • 00840018621497 ()


  • Periodontal curette
SCALER, DOUBLE END, UNIVERSITY OF NEBRASKA #128-128, DURALITE COLOR RINGS HANDLE
NORDENT MANUFACTURING INC
CESCNE128-128
In Commercial Distribution

  • 00840018619289 ()


  • Manual dental scaler, reusable
SCALER, DOUBLE END, UNIVERSITY OF TEXAS 103-106, DURALITE COLOR RINGS HANDLE
NORDENT MANUFACTURING INC
CESC103-106
In Commercial Distribution

  • 00840018617421 ()


  • Manual dental scaler, reusable
SCALER, DOUBLE END, UNIVERSITY OF SOUTHERN CAL #3-4, DURALITE ROUND HANDLE
NORDENT MANUFACTURING INC
RESCUSC3-4
In Commercial Distribution

  • 00840018617353 ()


  • Manual dental scaler, reusable
SCALER, DOUBLE END, UNIVERSITY OF TEXAS #103-106 FINE, DURALITE ROUND HANDLE
NORDENT MANUFACTURING INC
RESC103-106F
In Commercial Distribution

  • 00840018614314 ()


  • Manual dental scaler, reusable
SCALER, DOUBLE END, UNIVERSITY OF SOUTHERN CALIFORNIA #3-4, DURALITE HEX HANDLE
NORDENT MANUFACTURING INC
ESCUSC3-4
In Commercial Distribution

  • 00840018614093 ()


  • Manual dental scaler, reusable
CURETTE, DOUBLE END, UNIVERSITY OF CA RULE 3-4, DURALITE HEX HANDLE
NORDENT MANUFACTURING INC
ESCUC3-4
In Commercial Distribution

  • 00840018614086 ()


  • Periodontal curette
CURETTE, DOUBLE END, RATCLIFFE #3-4 UNIVERSITY OF CALIFORNIA, DURALITE HEX HANDLE
NORDENT MANUFACTURING INC
ESCR3-R4
In Commercial Distribution

  • 00840018613928 ()


  • Periodontal curette
SCALER, DOUBLE END, UNIVERSITY OF TEXAS #107-108, DURALITE COLOR RINGS HANDLE
NORDENT MANUFACTURING INC
CESCUT107-108
In Commercial Distribution

  • 00840018619579 ()


  • Manual dental scaler, reusable
CURETTE, DOUBLE END, UNIVERSITY OF CALIFORNIA #3-4, DURALITE COLOR RINGS HANDLE
NORDENT MANUFACTURING INC
CESCUC3-4
In Commercial Distribution

  • 00840018619555 ()


  • Periodontal curette
SCALER, DOUBLE END, UNIVERSITY OF SOUTHERN CALIFORNIA #3-4, #6 RELYANT HANDLE
NORDENT MANUFACTURING INC
TSCUSC3-4
In Commercial Distribution

  • 00840018623125 ()


  • Manual dental scaler, reusable
CURETTE, DOUBLE END, TRADE IN, INDIANA UNIVERSITY #17-18, #6 RELYANT HANDLE
NORDENT MANUFACTURING INC
TSCIU17-18
In Commercial Distribution

  • 00840018622531 ()


  • Periodontal curette
CURETTE, DOUBLE END, TRADE IN, INDIANA UNIVERSITY #13-14, #6 RELYANT HANDLE
NORDENT MANUFACTURING INC
TSCIU13-14
In Commercial Distribution

  • 00840018622524 ()


  • Periodontal curette
CURETTE, DOUBLE END, UNIVERSITY OF CALIFORNIA #3-4, XDURA DURALITE ROUND HANDLE
NORDENT MANUFACTURING INC
RENSUC3-4
In Commercial Distribution

  • 00840018646155 ()


  • Periodontal curette
Integra® Miltex® Cheek Retractor, 5-5/8" University of Minnesota
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
22D-209
In Commercial Distribution

  • H83422D2090 ()
  • 10381780413967 ()
22D-209

  • Hand-held dental retractor
OC-Auto SENSOR io Personal Use Kit, for The Ohio State University
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPUIO-OSU
In Commercial Distribution

  • 00816917027005 ()


  • Faecal occult blood IVD, reagent
Integra® Miltex® University of Kentucky Cassette, Rubber Dam Divider
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3-087000UKRD
In Commercial Distribution

  • H8343087000UKRD1 ()
  • 10381780169529 ()
3-087000UKRD

  • Device sterilization/disinfection container, reusable
Tri-R Post® Replacement Posts #3 - 2 Pack - University of Oklahoma
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-50051
Not in Commercial Distribution

  • H834012500511 ()
  • 10381780485698 ()
  • 00381780485691 ()
012-50051

  • Root canal post, preformed
Tri-R Post® Replacement Posts #2 - 2 Pack - University of Oklahoma
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-50050
Not in Commercial Distribution

  • H834012500501 ()
  • 10381780485681 ()
  • 00381780485684 ()
012-50050

  • Root canal post, preformed
PERIODONTAL SCALER INSERTS FOR CLEANING IMPLANTS, UNIVERSITY COLUMBIA FIG. 4T, >>TITANIUM<
Helmut Zepf Medizintechnik GmbH
24.751.104RC-TI
In Commercial Distribution

  • EZPF24751104RCTI0 ()
24.751.104RC-TI

  • Periodontal curette
PERIODONTAL SCALER INSERTS FOR CLEANING IMPLANTS, UNIVERSITY COLUMBIA FIG. 4L. >>TITANIUM<
Helmut Zepf Medizintechnik GmbH
24.751.104LC-TI
In Commercial Distribution

  • EZPF24751104LCTI0 ()
24.751.104LC-TI

  • Periodontal curette
UNIV. CURETTE PERIODONT., ZEPF-BIONIK COLUMBIA UNIVERSITY 13-14, COBALT BLUE, INSERTS INTERCHANGEABLE
Helmut Zepf Medizintechnik GmbH
24.207.13C
In Commercial Distribution

  • EZPF2420713C0 ()
24.207.13C

  • Periodontal curette
Kit Drug Urine Screen for University of Virginia Health System Only
AERO-MED, LLC
CA53350
In Commercial Distribution

  • 50885380202719 ()
  • 10885380202711 ()
CA53350

  • Urine specimen collection kit IVD
Blood Culture Collection Kit, Line Draw, The Ohio State University Only
AERO-MED, LLC
CA17675A
Not in Commercial Distribution

  • 50885380174931 ()
  • 10885380174933 ()
CA17675A

  • Phlebotomy kit
Blood Culture Collection Kit, Adult, Peripheral, The Ohio State University Only
AERO-MED, LLC
CA14725A
Not in Commercial Distribution

  • 50885380174924 ()
  • 10885380174926 ()
CA14725A

  • Phlebotomy kit
Blood Culture Collection Kit, Adult Central Line, University of Kansas Only
AERO-MED, LLC
CA12950B
Not in Commercial Distribution

  • 50885380174177 ()
  • 10885380174179 ()
CA12950B

  • Phlebotomy kit
Blood Culture Collection Kit Adult Central Line University of Kansas Only
AERO-MED, LLC
CA12925A
Not in Commercial Distribution

  • 50885380160828 ()
  • 10885380160820 ()
CA12925A

  • Phlebotomy kit
V. Mueller UNIVERSITY OF ILLINOIS STERNUM NEEDLE 18GA 1" (2.5CM) CANNULA
CAREFUSION 2200, INC
SU21001
Not in Commercial Distribution

  • 10885403130496 ()
SU21001

  • Body aspiration needle, reusable
V. Mueller UNIVERSITY OF ILLINOIS STERNUM NEEDLE 15GA 1" (2.5CM) CANNULA
CAREFUSION 2200, INC
SU21000
Not in Commercial Distribution

  • 10885403130489 ()
SU21000

  • Body aspiration needle, reusable
Tray Central Line Change W/O Dressing University Of Michigan MediChoice
OWENS & MINOR DISTRIBUTION, INC.
CLC1007B
In Commercial Distribution

  • 50885632108875 ()
  • 10885632108877 ()


  • Vascular catheterization support/maintenance kit, non-medicated
Original University Kit: (75) Matrices, (1) G100 G-Ring, (1) G200 G-Ring
GARRISON DENTAL SOLUTIONS, L.L.C.
UN15
In Commercial Distribution

  • 00810038096223 ()
UN15

  • Dental matrix band kit
Gold University Matrix Band Pack: 20 Count (10) AU100, (10) AU200
GARRISON DENTAL SOLUTIONS, L.L.C.
UN14
In Commercial Distribution

  • 00810038096216 ()
UN14

  • Dental matrix band kit
Standard Thyroid Guards - 0.50mm Lead Equivalence-REGULAR LEADED PROTECTIVE MEDIA
Techno-Aide, Inc.
TS-5R
In Commercial Distribution

  • G242TS5R90 ()
  • G242TS5R9 ()
TS-5R

  • Radiation shielding apron
Standard Thyroid Guards - 0.50mm Lead Equivalence-LEAD FREE PROTECTIVE MEDIA
Techno-Aide, Inc.
TS-5N
In Commercial Distribution

  • G242TS5N90 ()
  • G242TS5N9 ()
TS-5N

  • Radiation shielding apron
Standard Thyroid Guards - 0.50mm Lead Equivalence-LIGHTWEIGHT LEADED PROTECTIVE MEDIA
Techno-Aide, Inc.
TS-5L
In Commercial Distribution

  • G242TS5L90 ()
  • G242TS5L9 ()
TS-5L

  • Radiation shielding apron
Standard Thyroid Guards - 0.35mm Lead Equivalence-REGULAR LEADED PROTECTIVE MEDIA
Techno-Aide, Inc.
TS-3R
In Commercial Distribution

  • G242TS3R90 ()
  • G242TS3R9 ()
TS-3R

  • Radiation shielding apron
Standard Thyroid Guards - 0.35mm Lead Equivalence-LEAD FREE PROTECTIVE MEDIA
Techno-Aide, Inc.
TS-3N
In Commercial Distribution

  • G242TS3N90 ()
  • G242TS3N9 ()
TS-3N

  • Radiation shielding apron
Pediatric Thyroid Guards - 0.50mm Lead Equivalence-REGULAR LEADED PROTECTIVE MEDIA
Techno-Aide, Inc.
TP-5R
In Commercial Distribution

  • G242TP5R90 ()
  • G242TP5R9 ()
TP-5R

  • Radiation shielding apron
Pediatric Thyroid Guards - 0.50mm Lead Equivalence-LEAD FREE PROTECTIVE MEDIA
Techno-Aide, Inc.
TP-5N
In Commercial Distribution

  • G242TP5N90 ()
  • G242TP5N9 ()
TP-5N

  • Radiation shielding apron
Pediatric Thyroid Guards - 0.50mm Lead Equivalence-LIGHTWEIGHT LEADED PROTECTIVE MEDIA
Techno-Aide, Inc.
TP-5L
In Commercial Distribution

  • G242TP5L90 ()
  • G242TP5L9 ()
TP-5L

  • Radiation shielding apron
Standard Thyroid Guards - 0.35mm Lead Equivalence-LIGHTWEIGHT LEADED PROTECTIVE MEDIA
Techno-Aide, Inc.
TS-3L
In Commercial Distribution

  • G242TS3L90 ()
  • G242TS3L9 ()
TS-3L

  • Radiation shielding apron
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