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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DB BKT LP LR 2ND BIC 018 T-17 A+2 R=0 HK/DIST BEV OFFSET PAD GP
AMERICAN ORTHODONTICS CORPORATION
393-8217BAU
Not in Commercial Distribution

  • 00190746164453 ()
393-8217BAU

  • Orthodontic bracket, metal
DB BKT LP LL 1ST BIC 018 T-12 A+2 R=0 GP OFFSET PAD W/HK DIST
AMERICAN ORTHODONTICS CORPORATION
393-8216BAU
In Commercial Distribution

  • 00190746164446 ()
393-8216BAU

  • Orthodontic bracket, metal
DB BKT LP LR 1ST BIC 018 T-12 A+2 R=0 GP OFFSET PAD W/HK DIST
AMERICAN ORTHODONTICS CORPORATION
393-8215BAU
In Commercial Distribution

  • 00190746164439 ()
393-8215BAU

  • Orthodontic bracket, metal
DB BKT LP UL 1ST BIC 018 T-7 A=0 R=0 GP OFFSET PAD W/HK DIST
AMERICAN ORTHODONTICS CORPORATION
393-8909HDAU
In Commercial Distribution

  • 00190746164415 ()
393-8909HDAU

  • Orthodontic bracket, metal
DB BKT LP UR 1ST BIC 018 T-7 A=0 R=0 GP OFFSET PAD W/HK DIST
AMERICAN ORTHODONTICS CORPORATION
393-8908HDAU
In Commercial Distribution

  • 00190746164408 ()
393-8908HDAU

  • Orthodontic bracket, metal
DB BKT MASTER HGW UL BIC 022 T-7 A=0 R=0 GP OFFSET PAD W/HK MES
AMERICAN ORTHODONTICS CORPORATION
390-8829BAU
In Commercial Distribution

  • 00190746164057 ()
390-8829BAU

  • Orthodontic bracket, metal
DB BKT MASTER HGW UR BIC 022 T-7 A=0 R=0 GP OFFSET PAD W/HK MES
AMERICAN ORTHODONTICS CORPORATION
390-8828BAU
In Commercial Distribution

  • 00190746164040 ()
390-8828BAU

  • Orthodontic bracket, metal
DB BKT MINI MS HGW LL 1ST BIC 018 T-12 A+2 R=0 GP W/HK DIST
AMERICAN ORTHODONTICS CORPORATION
390-1513BAU
In Commercial Distribution

  • 00190746163623 ()
390-1513BAU

  • Orthodontic bracket, metal
DB BKT MINI MS HGW LR 1ST BIC 018 T-12 A+2 R=0 GP W/HK DIST
AMERICAN ORTHODONTICS CORPORATION
390-1512BAU
In Commercial Distribution

  • 00190746163616 ()
390-1512BAU

  • Orthodontic bracket, metal
The tremoflo C-100 Airwave Oscillometry System & Accessories - Vitalograph US Healthcare Edition is compatible with Vitalograph's Eco BVF with Bit Lip Filter (28553).
Thorasys Thoracic Medical Systems Inc
102181
In Commercial Distribution

  • 07540261021817 ()


  • Pulmonary function analysis system, adult
DB BKT MASTER HGW LL 2ND BIC 022 T-17 A+2 R=0 GP OFFSET PAD W/HK DIST
AMERICAN ORTHODONTICS CORPORATION
390-8717BAU
In Commercial Distribution

  • 00190746164026 ()
390-8717BAU

  • Orthodontic bracket, metal
DB BKT MASTER HGW LR 2ND BIC 022 T-17 A+2 R=0 GP OFFSET PAD W/HK DIST
AMERICAN ORTHODONTICS CORPORATION
390-8716BAU
In Commercial Distribution

  • 00190746164019 ()
390-8716BAU

  • Orthodontic bracket, metal
DB BKT MASTER HGW LL 1ST BIC 022 T-12 A+2 R=0 GP OFFSET PAD W/HK DIST
AMERICAN ORTHODONTICS CORPORATION
390-8713BAU
In Commercial Distribution

  • 00190746164002 ()
390-8713BAU

  • Orthodontic bracket, metal
DB BKT MASTER HGW LR 1ST BIC 022 T-12 A+2 R=0 GP OFFSET PAD W/HK DIST
AMERICAN ORTHODONTICS CORPORATION
390-8712BAU
In Commercial Distribution

  • 00190746163999 ()
390-8712BAU

  • Orthodontic bracket, metal
A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
PRO-LAB, INCORPORATED
PL.6123
In Commercial Distribution

  • 05060472462404 ()
PL.6123

  • Multiple Salmonella species antigen IVD, kit, rapid agglutination, clinical
No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755136643 ()
M-000.09.556

  • Aneroid manual sphygmomanometer
No Description
Roche Diagnostics GmbH
11895362160
In Commercial Distribution

  • 00075537171455 ()
11895362160

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
No Description
Drägerwerk AG & Co. KGaA
MP00994
In Commercial Distribution

  • 04048675250296 ()
  • 04048675421672 ()


  • General-purpose patient temperature probe, single-use
No Description
Drägerwerk AG & Co. KGaA
MP00993
In Commercial Distribution

  • 04048675250272 ()
  • 04048675421689 ()


  • General-purpose patient temperature probe, single-use
No Description
Drägerwerk AG & Co. KGaA
MP00992
In Commercial Distribution

  • 04048675250265 ()
  • 04048675421696 ()


  • General-purpose patient temperature probe, single-use
No Description
Drägerwerk AG & Co. KGaA
MP00991
In Commercial Distribution

  • 04048675250258 ()
  • 04048675421702 ()


  • General-purpose patient temperature probe, single-use
No Description
ALIMED, INC.
1104612
In Commercial Distribution

  • 00733657285765 ()
2970000069

  • Wheelchair seat cushion
No Description
ALIMED, INC.
11046
In Commercial Distribution

  • 00733657224757 ()
2970000068

  • Wheelchair seat cushion
No Description
ALIMED, INC.
11044
In Commercial Distribution

  • 00733657224733 ()
2970000066

  • Wheelchair seat cushion
PATIENT TRANSFER KIT C, 25EA TS PT TRANS KIT, GOWN, TF BLKT, ST SHEET, PC, 1/BG, 25 BG/CS
Encompass Group, L.L.C.
5400-210
In Commercial Distribution

  • 10612899004402 ()
  • 00612899004405 ()


  • Hypothermia-prevention whole-body suit
PATIENT TRANSFER KIT D, 25EA TS PT TRANS KIT, GOWN TF BLKT ST SHEET PC PILL 1/BG 25 BG/CS
Encompass Group, L.L.C.
5400-230
In Commercial Distribution

  • 50612899286899 ()
  • 00612899286894 ()


  • Hypothermia-prevention whole-body suit
2 year valid Reference Load (15 cm H2O.s/L) to verify tremoflo Airwave Oscillometry System calibration.
Thorasys Thoracic Medical Systems Inc
102069
In Commercial Distribution

  • 07540261020698 ()


  • Pulmonary function analysis system, adult
The tremoflo C-100 Airwave Oscillometry System and Accessories - Vitalograph Clinical Trial Edition is compatible with Vitalograph's Blue BVP with Bit Lip Filter (28350).
Thorasys Thoracic Medical Systems Inc
101761
In Commercial Distribution

  • 07540261017612 ()


  • Pulmonary function analysis system, adult
No Description
MASUNAGA OPTICAL MFG.CO.,LTD.
MP-103 11 GP 45
In Commercial Distribution

  • 04582644468959 ()


  • Spectacle frame
No Description
MASUNAGA OPTICAL MFG.CO.,LTD.
MP-102 11 GP 45
In Commercial Distribution

  • 04582644468928 ()


  • Spectacle frame
No Description
MASUNAGA OPTICAL MFG.CO.,LTD.
MP-670-FB 2-1 GP 48
In Commercial Distribution

  • 04582644472161 ()


  • Spectacle frame
No Description
MASUNAGA OPTICAL MFG.CO.,LTD.
MP-101 11 GP 48
In Commercial Distribution

  • 04582644468874 ()


  • Spectacle frame
No Description
MASUNAGA OPTICAL MFG.CO.,LTD.
MP-3305 11 GP 54
In Commercial Distribution

  • 04582647300645 ()


  • Spectacle frame
No Description
MASUNAGA OPTICAL MFG.CO.,LTD.
MP-3303 11 GP 54
In Commercial Distribution

  • 04582647300577 ()


  • Spectacle frame
ENF-GP PORTABLE RHINO-LARYNGO FIBERSCOPE
OLYMPUS MEDICAL SYSTEMS CORP.
OLYMPUS ENF TYPE GP
In Commercial Distribution

  • 04953170078231 ()


  • Flexible fibreoptic nasopharyngolaryngoscope
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
OLYMPUS ENF TYPE GP
Not in Commercial Distribution

  • 04953170318191 ()


  • Flexible fibreoptic nasopharyngolaryngoscope
No Description
GENERAL ELECTRIC COMPANY
1.5T GP FLEX COIL
In Commercial Distribution

  • 00840682116145 ()


  • MRI system coil, radio-frequency
RHINO-LARYNGOFIBERSCOPE
OLYMPUS MEDICAL SYSTEMS CORP.
OLYMPUS ENF TYPE GP
In Commercial Distribution

  • 04953170411052 ()


  • Flexible fibreoptic nasopharyngolaryngoscope
Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device.
Austin Medical Products, Inc.
GP with 1" Hole
In Commercial Distribution

  • 00838234009991 ()
  • 00838234000851 ()


  • Absorbent stomal dressing
No Description
Bonebridge AG
B-122110
In Commercial Distribution

  • 07640187461343 ()


  • Orthopaedic fixation plate, non-bioabsorbable
No Description
Bonebridge AG
B-121110
In Commercial Distribution

  • 07640187461336 ()


  • Orthopaedic fixation plate, non-bioabsorbable
No Description
Bonebridge AG
B-122010
In Commercial Distribution

  • 07640187461329 ()


  • Orthopaedic fixation plate, non-bioabsorbable
No Description
Bonebridge AG
B-121010
In Commercial Distribution

  • 07640187461312 ()


  • Orthopaedic fixation plate, non-bioabsorbable
No Description
MASUNAGA OPTICAL MFG.CO.,LTD.
OCEAN DRIVE 39 SG-BK/GP/GRY GP Mirror 53
In Commercial Distribution

  • 04582644463732 ()


  • Tinted non-prescription spectacles
Isolation Transformer for EEG/EMG/EP systems
EB NEURO SPA
B9700041000
In Commercial Distribution

  • 08056446900666 ()


  • Constant-voltage transformer
Isolation Transformer for EEG/EMG/EP systems
EB NEURO SPA
B9700041001
In Commercial Distribution

  • 08056446900659 ()


  • Constant-voltage transformer
No Description
ALIMED, INC.
1104712
In Commercial Distribution

  • 00733657285772 ()
2970000071

  • Wheelchair seat cushion
PLATE DRY CLI GRAM+ ID AUTO A semi-quantitative test intended for the automated identification of Gram positive bacterial isolates based on biochemical reactions. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, the device requires an automated system to produce a result and requires a pure, agar grown culture. This device is for professional use only and is not a companion diagnostic.
REMEL, INC.
GPID
In Commercial Distribution

  • 00848838074363 ()


  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
No Description
MASUNAGA OPTICAL MFG.CO.,LTD.
GMS-118 11 Clear/GP 47
In Commercial Distribution

  • 04580786580003 ()


  • Spectacle frame
No Description
MASUNAGA OPTICAL MFG.CO.,LTD.
Vela 11 SG-DEMI/GP 48
In Commercial Distribution

  • 04582644468720 ()


  • Tinted non-prescription spectacles
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