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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Internal Hex USA
TERRATS MEDICAL SL.
88.017/5
In Commercial Distribution

  • 08435457269663 ()
ODSA-TSV305

  • Dental implant suprastructure, permanent, preformed
Internal Hex "Click"
TERRATS MEDICAL SL.
88.016/5
In Commercial Distribution

  • 08435457269601 ()
ODSA-CERT505

  • Dental implant suprastructure, permanent, preformed
Internal Hex "Click"
TERRATS MEDICAL SL.
88.015/5
In Commercial Distribution

  • 08435457269540 ()
ODSA-CERT405

  • Dental implant suprastructure, permanent, preformed
Internal Hex "Click"
TERRATS MEDICAL SL.
88.014/5
In Commercial Distribution

  • 08435457269489 ()
ODSA-CERT305

  • Dental implant suprastructure, permanent, preformed
External Hex USA
TERRATS MEDICAL SL.
88.013/5
In Commercial Distribution

  • 08435457269427 ()
ODSA-EXHEX505

  • Dental implant suprastructure, permanent, preformed
External Hex USA
TERRATS MEDICAL SL.
88.011/5
In Commercial Distribution

  • 08435457269366 ()
ODSA-EXHEX305

  • Dental implant suprastructure, permanent, preformed
External Hex USA
TERRATS MEDICAL SL.
88.002/5
In Commercial Distribution

  • 08435457269304 ()
ODSA-EXHEX405

  • Dental implant suprastructure, permanent, preformed
Internal Hex USA
TERRATS MEDICAL SL.
88.019/5
In Commercial Distribution

  • 08435457259817 ()
ODS-TSV505

  • Dental implant suprastructure, permanent, preformed
Internal Hex USA
TERRATS MEDICAL SL.
88.018/5
In Commercial Distribution

  • 08435457259756 ()
ODS-TSV405

  • Dental implant suprastructure, permanent, preformed
NEO GM
TERRATS MEDICAL SL.
88.035/5
In Commercial Distribution

  • 08435750427647 ()
ODSA-NG345

  • Dental implant suprastructure, permanent, preformed
Software application for ophthalmic image management system with a browser-based interface for image review and analysis of ophthalmic images. Software utilizing available data from ophthalmic devices to provide views and tools that are clinically useful in helping to diagnose and monitor. A picture archiving and communication system to allow storage, retrieval, analysis, and management of digital images of the eye. Provides integration of different ophthalmic devices for any imaging modality. Complaint with DICOM interoperability standard and can integrate any DICOM-compliant device, including using DICOM modality worklists. Axis can integrate non-DICOM devices to provide data and imaging regardless of device type. Can be integrated with any EHR system via HL7 interface or other means. Functionality and access to images can be from AXIS server or AXIS cloud.
SONOMED, INC.
Ver 5
In Commercial Distribution

  • 00896100002002 ()
Axis

  • Ophthalmology PACS software
NEO GM
TERRATS MEDICAL SL.
88.035/5
In Commercial Distribution

  • 08435750427708 ()
ODS-NG345

  • Dental implant suprastructure, permanent, preformed
Conical BL
TERRATS MEDICAL SL.
20.042/5
In Commercial Distribution

  • 08435750408851 ()
ARSBL-HA415NS

  • Dental implant suprastructure, permanent, preformed
Conical BL
TERRATS MEDICAL SL.
20.041/5
In Commercial Distribution

  • 08435750408820 ()
ARSBL-HA335NS

  • Dental implant suprastructure, permanent, preformed
Internal Hex BH
TERRATS MEDICAL SL.
88.087/5
In Commercial Distribution

  • 08435750408332 ()
ODSA-BHI3555

  • Dental implant suprastructure, permanent, preformed
Internal Hex Conic
TERRATS MEDICAL SL.
88.025/5
In Commercial Distribution

  • 08435750407595 ()
ODSA-DATX455

  • Dental implant suprastructure, permanent, preformed
External Hex Universal
TERRATS MEDICAL SL.
88.002/5
In Commercial Distribution

  • 08435750407212 ()
ODSA-NB415

  • Dental implant suprastructure, permanent, preformed
Restore is a personal lubricant for penile and/or vaginal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
GOOD CLEAN LOVE, INC.
5 mL
In Commercial Distribution

  • 00893268000710 ()
  • 30893268000711 ()
  • 00850044065011 ()
  • 00850044065110 ()
500101

  • Sexual lubricant
Personal lubricant for vaginal/penile application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication.
GOOD CLEAN LOVE, INC.
5 mL
In Commercial Distribution

  • 00893268000260 ()
  • 30850014621217 ()
  • 30893268000261 ()
  • 00850014621964 ()
  • 00850044065080 ()
200705

  • Sexual lubricant
Biological Indicator intended for steam sterilization (121C). Contains spores of Geobacillus stearothermophilus. 50 units / box
MESA LABORATORIES, INC.
Log 5
Not in Commercial Distribution

  • M985PS2351 ()
  • M985PS23550 ()
PS2-3-5-50

  • Biological sterilization indicator
Self-contained biological indicator for use in steam sterilization processes. Log 5 population. 25 count box.
MESA LABORATORIES, INC.
Log 5
In Commercial Distribution

  • M985SEZS5251 ()
  • M985SEZS5250 ()
SEZS/525

  • Biological sterilization indicator
Self-contained biological indicator for use in steam sterilization. Log 5. 50 count package.
MESA LABORATORIES, INC.
Log 5
Not in Commercial Distribution

  • M985PS235501 ()
  • M985PS235500 ()
PS2-3-5-50

  • Biological sterilization indicator
Calcium compound bone void filler with DBM (5cc), Previously sold under Trabexus® EB brand name.
Vivorte, Inc
5 cc
In Commercial Distribution

  • W4146EB0005T0475 ()
130703-05

  • Cadaveric-donor/synthetic mineral bone graft
Internal Hex USA
TERRATS MEDICAL SL.
88.017/5
In Commercial Distribution

  • 08435457259695 ()
ODS-TSV305

  • Dental implant suprastructure, permanent, preformed
External Hex USA
TERRATS MEDICAL SL.
88.013/5
In Commercial Distribution

  • 08435457259466 ()
ODS-EXHEX505

  • Dental implant suprastructure, permanent, preformed
External Hex USA
TERRATS MEDICAL SL.
88.002/5
In Commercial Distribution

  • 08435457259404 ()
ODS-EXHEX405

  • Dental implant suprastructure, permanent, preformed
External Hex USA
TERRATS MEDICAL SL.
88.011/5
In Commercial Distribution

  • 08435457259343 ()
ODS-EXHEX305

  • Dental implant suprastructure, permanent, preformed
Internal Hex "Click"
TERRATS MEDICAL SL.
88.016/5
In Commercial Distribution

  • 08435457259275 ()
ODS-CERT505

  • Dental implant suprastructure, permanent, preformed
Internal Hex "Click"
TERRATS MEDICAL SL.
88.015/5
In Commercial Distribution

  • 08435457259213 ()
ODS-CERT405

  • Dental implant suprastructure, permanent, preformed
Internal Hex "Click"
TERRATS MEDICAL SL.
88.014/5
In Commercial Distribution

  • 08435457259152 ()
ODS-CERT305

  • Dental implant suprastructure, permanent, preformed
One vial per foil pouch
RITEDOSE PHARMACEUTICALS, LLC
5 mL
In Commercial Distribution

  • 00376204300018 ()
  • 00376204300964 ()


  • Inhalation therapy saline solution, isotonic
MyCRO Band w/Lining blue
OTTO BOCK HEALTHCARE
24H1=5
In Commercial Distribution

  • 04064409000074 ()


  • Cranial orthosis
No Description
RITEDOSE PHARMACEUTICALS, LLC
5 mL
In Commercial Distribution

  • 00376204500050 ()
  • 00376204500999 ()


  • Inhalation therapy sterile water
No Description
RITEDOSE PHARMACEUTICALS, LLC
5 mL
In Commercial Distribution

  • 00376204400053 ()
  • 00376204400992 ()


  • Inhalation therapy saline solution, isotonic
No Description
RITEDOSE PHARMACEUTICALS, LLC
5 mL
In Commercial Distribution

  • 00376204300056 ()
  • 00376204300995 ()


  • Inhalation therapy saline solution, isotonic
short-term patient stabilization device
iSYS Medizintechnik GmbH
Fleece 5
In Commercial Distribution

  • 09010279000107 ()

  • Length: 30 Meter
  • Width: 50 Millimeter
31618

  • Limb/torso/head restraint, single-use
MAC 5 A5
Ge Medical Systems Information Technologies, Inc.
5 A5
In Commercial Distribution

  • 00195278276124 ()
8855002-001

  • Electrocardiograph, professional, multichannel
MAC 5 Lite
Ge Medical Systems Information Technologies, Inc.
5 LITE
In Commercial Distribution

  • 00195278276087 ()
8855003-001

  • Electrocardiograph, professional, multichannel
MAC 5 A4
Ge Medical Systems Information Technologies, Inc.
5 A4
In Commercial Distribution

  • 00195278276070 ()
8855001-001

  • Electrocardiograph, professional, multichannel
Explorer, Double Ended
A. TITAN INSTRUMENTS, INC.
Expl 5
In Commercial Distribution

  • 00841685109530 ()


  • Dental surgical probe, reusable
Straight, 5mm, Red, D-Lux Elevator
A. TITAN INSTRUMENTS, INC.
Lux 5
In Commercial Distribution

  • 00841685110062 ()


  • Dental elevator, tooth/root
BLU 2X5 LATX FREE 36/CS
FISHER SCIENTIFIC COMPANY L.L.C.
KZ402-NO.5
In Commercial Distribution

  • 20613647002531 ()
  • 00613647002537 ()
  • 10613647002534 ()
22363123

  • Non-adhesive device retention bandage
BLU 1.5X5 LATX FREE 48/CS
FISHER SCIENTIFIC COMPANY L.L.C.
KZ401.5-NO.5
In Commercial Distribution

  • 20613647002456 ()
  • 00613647002452 ()
  • 10613647002459 ()
22363112

  • Non-adhesive device retention bandage
BLU 1X5 LATX FREE 30/CS
FISHER SCIENTIFIC COMPANY L.L.C.
KZ401-NO.5
In Commercial Distribution

  • 20613647002371 ()
  • 00613647002377 ()
  • 10613647002374 ()
22363101

  • Non-adhesive device retention bandage
Bone Curette 3.0mm
Hoogland Spine Products GmbH
1001-ABR 5
In Commercial Distribution

  • 04260200313720 ()


  • Bone curette, reusable
BSG10/FUS12/MBP20SX/MBP20SX/CST20NE12
Saeshin Precision Co., Ltd.
SSG10 #5
In Commercial Distribution

  • 08809260474017 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
'1:1, Contra Angle(Button Type #2) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL(B)-03C
Saeshin Precision Co., Ltd.
X-CUBE #5
In Commercial Distribution

  • 08809260470828 ()


  • Dental power tool system, line-powered
Periodontal Instrument, Scaler, double-ended
A. TITAN INSTRUMENTS, INC.
GF 5
In Commercial Distribution

  • 00841685106621 ()


  • Manual dental scaler, reusable
Periotome Tip, Counter-angled
A. TITAN INSTRUMENTS, INC.
P 5
In Commercial Distribution

  • 00841685104733 ()


  • Periotome, reusable
Sinus lift instrument, Sinus Elevator
A. TITAN INSTRUMENTS, INC.
Sinus 5
In Commercial Distribution

  • 00841685103729 ()


  • Dental elevator, sinus lift
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