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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PERFORMATRAK FULL MASK WITH STANDARD ELBOW, WITH CAPSTRAP, LARGE
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, LARGE
In Commercial Distribution

  • 30606959007568 ()
  • 00606959007567 ()
1048719

  • CPAP/BPAP face mask, single-use
PERFORMATRAK FULL MASK WITH STANDARD ELBOW, WITH CAPSTRAP, MEDIUM
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, MEDIUM
In Commercial Distribution

  • 30606959007551 ()
  • 00606959007550 ()
1048720

  • CPAP/BPAP face mask, single-use
PERFORMATRAK FULL MASK WITH STANDARD ELBOW, WITH CAPSTRAP, SMALL
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, SMALL
In Commercial Distribution

  • 30606959007544 ()
  • 00606959007543 ()
1048721

  • CPAP/BPAP face mask, single-use
REMstar Auto A-Flex with Humidifier, with SD Card, China
Respironics, Inc.
REMstar Auto A-Flex with Humidifier, with SD Card, China
Not in Commercial Distribution

  • 00606959001046 ()
CN557HS

  • Home CPAP unit
AF531 Mask with Standard Elbow, with CapStrap, Small, USA
Respironics, Inc.
AF531 Mask w/SE, with CapStrap, Small, USA
In Commercial Distribution

  • 30606959012289 ()
  • 00606959012288 ()
1094805

  • CPAP/BPAP face mask, single-use
AF531 Mask with Entrainment Elbow, with CapStrap, Medium, USA
Respironics, Inc.
AF531 Mask EE with CapStrap, Medium, USA
Not in Commercial Distribution

  • 30606959012265 ()
  • 00606959012264 ()
1094803

  • CPAP/BPAP face mask, single-use
AF531 Mask with Entrainment Elbow, with CapStrap, Small, USA
Respironics, Inc.
AF531 Mask EE with CapStrap, Small, USA
In Commercial Distribution

  • 30606959012258 ()
  • 00606959012257 ()
1094802

  • CPAP/BPAP face mask, single-use
Panoramic X-ray Assembly with Cephalometric Extension with no sensor
MIDMARK CORPORATION
60-A1019
In Commercial Distribution

  • 00841709102585 ()
60-A1019

  • Stationary cephalometric x-ray system, digital
ELVAREX PLUS 1/GLOVE/WITH FINGER, WITH THUMB/RED
BSN-Jobst GmbH
79540-00016-00
In Commercial Distribution

  • 04059993310838 ()

  • Pressure 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX PLUS 2/GLOVE/WITH FINGER, WITH THUMB/RED
BSN-Jobst GmbH
79541-00016-00
In Commercial Distribution

  • 04059993310814 ()

  • Pressure 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX FORTE 2/GLOVE/WITH FINGER, WITH THUMB/NAVY
BSN-Jobst GmbH
79581-00020-00
In Commercial Distribution

  • 04059993103690 ()

  • Pressure 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 2/GLOVE/WITH FINGER, WITH THUMB/ZIPPER/NAVY
BSN-Jobst GmbH
77558-00053-00
In Commercial Distribution

  • 04059993101825 ()

  • Pressure 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX PLUS 1/GLOVE/WITH FINGER, WITH THUMB/NAVY
BSN-Jobst GmbH
79540-00010-00
In Commercial Distribution

  • 04059993077380 ()

  • Pressure 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX FORTE 2/GLOVE/WITH FINGER, WITH THUMB/CHERRY
BSN-Jobst GmbH
79581-00038-00
In Commercial Distribution

  • 04059993075799 ()

  • Pressure 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX PLUS 2/GLOVE/WITH FINGER, WITH THUMB/BEIGE
BSN-Jobst GmbH
79541-00020-00
In Commercial Distribution

  • 04059993700806 ()

  • Pressure 23-32 mmHg
79541-00020-00

  • Compression/pressure glove
Castroviejo Suturing Forceps, 0.5mm, With Tying Platform, With Lock
KRISHNA IMPORTS INC
S5-1576
In Commercial Distribution

  • 00810799034526 ()
S5-1576

  • Ophthalmic surgical device handling forceps, reusable
Castroviejo Suturing Forceps, 0.3mm, With Tying Platform, With Lock
KRISHNA IMPORTS INC
S5-1571
In Commercial Distribution

  • 00810799034502 ()
S5-1571

  • Ophthalmic surgical device handling forceps, reusable
Castroviejo Suturing Forceps, 0.12mm, With Tying Platform, With Lock
KRISHNA IMPORTS INC
S5-1561
In Commercial Distribution

  • 00810799034472 ()
S5-1561

  • Ophthalmic surgical device handling forceps, reusable
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100040ATS
In Commercial Distribution

  • M665100040ATS3 ()
  • M665100040ATS1 ()
  • M665100040ATS0 ()

  • 40 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100036ATS
In Commercial Distribution

  • M665100036ATS3 ()
  • M665100036ATS1 ()
  • M665100036ATS0 ()

  • 36 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100032ATS
In Commercial Distribution

  • M665100032ATS3 ()
  • M665100032ATS1 ()
  • M665100032ATS0 ()

  • 32 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100028ATS
In Commercial Distribution

  • M665100028ATS3 ()
  • M665100028ATS1 ()
  • M665100028ATS0 ()

  • 28 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100024ATS
In Commercial Distribution

  • M665100024ATS3 ()
  • M665100024ATS1 ()
  • M665100024ATS0 ()

  • 24 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100020ATS
In Commercial Distribution

  • M665100020ATS3 ()
  • M665100020ATS1 ()
  • M665100020ATS0 ()

  • 20 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100016ATS
In Commercial Distribution

  • M665100016ATS3 ()
  • M665100016ATS1 ()
  • M665100016ATS0 ()

  • 16 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100014ATS
In Commercial Distribution

  • M665100014ATS3 ()
  • M665100014ATS1 ()
  • M665100014ATS0 ()

  • 14 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100012ATS
In Commercial Distribution

  • M665100012ATS3 ()
  • M665100012ATS1 ()
  • M665100012ATS0 ()

  • 12 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100010ATS
In Commercial Distribution

  • M665100010ATS3 ()
  • M665100010ATS1 ()
  • M665100010ATS0 ()

  • 10 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100008ATS
In Commercial Distribution

  • M665100008ATS3 ()
  • M665100008ATS1 ()
  • M665100008ATS0 ()

  • 8 FR


  • Pleural catheter
Vacuum tubing with coupling Piece with disposable collection system
Medela AG
077.0154
In Commercial Distribution

  • 07612367045872 ()


  • Suction/irrigation tubing, single-use
Smart Outlet with floor mat with remote reset button
Smart Caregiver Corporation
433SFM5-SYS
In Commercial Distribution

  • 00812293013816 ()


  • Bed/chair occupant movement pressure/vibration sensor
Smart Outlet with CordLess bed pad with remote reset
Smart Caregiver Corporation
RP-433SBR1-SYS
In Commercial Distribution

  • 00812293013007 ()


  • Bed/chair occupant movement pressure/vibration sensor
Smart Outlet with floor mat with remote reset button
Smart Caregiver Corporation
433SFM7-SYS
In Commercial Distribution

  • 00812293011942 ()


  • Bed/chair occupant movement pressure/vibration sensor
Handle with quick coupling, with torque limiter 3.5 Nm
aap Implantate AG
IU 7707-35
In Commercial Distribution

  • 04042409262241 ()


  • Surgical instrument torque limiter
Handle with quick coupling, with torque limiter 2.0 Nm
aap Implantate AG
IU 7707-20
In Commercial Distribution

  • 04042409262234 ()


  • Surgical instrument torque limiter
Handle with quick coupling, with torque limiter 1.5 Nm
aap Implantate AG
IU 7707-15
In Commercial Distribution

  • 04042409262227 ()


  • Surgical instrument torque limiter
Sterile (14x30cm) CIV-Flex cover with applicator with PEELSafe Advantage
CIVCO MEDICAL INSTRUMENTS CO., INC.
610-2290, 610-2290-5
In Commercial Distribution

  • 00841436111836 ()
  • 10841436111833 ()
  • 00841436111867 ()
610-2290, 610-2290-5

  • Body-surface ultrasound imaging transducer cover
10mm Babcock with Pyramid Serrations, Standard Handle, With Rotation
Endoplus
E446SR
In Commercial Distribution

  • 00817401026047 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
10mm Babcock with Pyramid Serrations, Ratcheting Handle, With Rotation
Endoplus
E446RR
In Commercial Distribution

  • 00817401026030 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
5mm Maryland with Cross Serrations, Standard Handle, With Rotation
Endoplus
E378SR
In Commercial Distribution

  • 00817401025446 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
5mm Maryland with Cross Serrations, Monopolar Handle, With Rotation
Endoplus
E378MR
In Commercial Distribution

  • 00817401025422 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
Scan Body with Screw Compatible with Zimmer Screw-Vent 5.7
Biodenta Swiss AG
CAD-SBZTSV57
In Commercial Distribution

  • 07640169735578 ()
CAD-SBZTSV57

  • Dental implant abutment analog, intraoral-scanning, single-use
Scan Body with Screw Compatible with Zimmer Screw-Vent 4.5
Biodenta Swiss AG
CAD-SBZTSV45
In Commercial Distribution

  • 07640169735561 ()
CAD-SBZTSV45

  • Dental implant abutment analog, intraoral-scanning, single-use
Scan Body with Screw Compatible with Zimmer Screw-Vent 3.5
Biodenta Swiss AG
CAD-SBZTSV35
In Commercial Distribution

  • 07640169735554 ()
CAD-SBZTSV35

  • Dental implant abutment analog, intraoral-scanning, single-use
CROWN RING REMOVER, MILLER, WITH 3 POINTS (WITH WEIGHT)
Helmut Zepf Medizintechnik GmbH
19.272.00
In Commercial Distribution

  • EZPF19272000 ()
19.272.00

  • Dental prosthesis removal instrument
3.4mm Bulldog Grasping Forceps With Ring Handle With Ratchet
Surgical Direct, Inc.
SD48-8453
In Commercial Distribution

  • B382SD4884530 ()
SD48-8453

  • Spinal rongeur
Laparoscopic Instrument with Flex Arm 760mm, with Table Clamp
Surgical Direct, Inc.
SD05409
In Commercial Distribution

  • B382SD054090 ()
SD05409

  • Endoscope sheath, reusable
TiOS Scan Body with Screw Compatible with Biodenta B0
Biodenta Swiss AG
CAD-TSBBDBLB0S
In Commercial Distribution

  • 07640169736834 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
TiOS Scan Body with Screw Compatible with Biodenta B2
Biodenta Swiss AG
CAD-TSBBDBLB2S
In Commercial Distribution

  • 07640169736407 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
TiOS Scan Body with Screw Compatible with Biodenta B1
Biodenta Swiss AG
CAD-TSBBDBLB1S
In Commercial Distribution

  • 07640169736391 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
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