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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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NA - 07332747175257

Guide Pin Implant Level CC 3.0 20mm
Nobel Biocare AB
36792
Not in Commercial Distribution

  • 07332747175257 ()

  • Length: 20.000 Millimeter
36792

  • Dental implant suprastructure, temporary, preformed, reusable

NA - 04055207070086

CHECKLIST APP This app requires core.portal. The checklist app is a universal questionnaire and checklist system for collecting information during surgery. Checklists can be defined as customer-specific multilingual templates. The checklists are displayed in accordance with the language selected in the core.browser. The app generates a PDF report with the demographic patient data, information about the surgical intervention, a logo and the recorded data. The report is part of the documentation. The app does not spread the information collected.
Richard Wolf GmbH
5597706
Not in Commercial Distribution

  • 04055207070086 ()
5597706

  • Operating room audiovisual data/device management system application software

Hepro.us - Box of 25 Flush Syringe 60cc - 00850578007570

Hepro.us - Box of 25 Flush Syringe 60cc No needle
HEPRO.US INC.
BX 60ml/cc
In Commercial Distribution

  • 00850578007570 ()
  • 85057800757001 ()


  • Irrigation syringe

HYPE stem - 03662200019663

No Description
SOC ETUDES RECHERCHES FABRICATION
TE607- 36 CC
In Commercial Distribution

  • 03662200019663 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

HYPE stem - 03662200019601

No Description
SOC ETUDES RECHERCHES FABRICATION
TE607- 28 CC
In Commercial Distribution

  • 03662200019601 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

HYPE stem - 03662200019632

No Description
SOC ETUDES RECHERCHES FABRICATION
TE607- 32 CC
In Commercial Distribution

  • 03662200019632 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

HYPE stem - 03662200019571

No Description
SOC ETUDES RECHERCHES FABRICATION
TE607- 22.2 CC
In Commercial Distribution

  • 03662200019571 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

MectaBone-G - 03760177041196

No Description
TEKNIMED
Granules 10 cc
Not in Commercial Distribution

  • 03760177041196 ()

  • Granules
  • Pore Size: 220 Micrometer
  • Weight: 6.3 Gram
03.02.002

  • Bone matrix implant, synthetic, non-antimicrobial

Bathmate - 05060140209928

Bathmate Hydro 7 Crystal Clear
DX PRODUCTS LIMITED
Hydro 7 CC
In Commercial Distribution

  • 05060140209959 ()
  • 05060140209928 ()
  • 05060140209942 ()
  • 05060140209935 ()

  • Lumen/Inner Diameter: 2 Inch
  • Depth: 7 Inch
BM-H7-CC

  • Penile vacuum device

Bathmate - 05060140209805

bathmate Hydromax 5 Crystal Clear
DX PRODUCTS LIMITED
Hydromax 5 CC
In Commercial Distribution

  • 05060140209836 ()
  • 05060140209805 ()
  • 05060140209829 ()
  • 05060140209812 ()

  • Lumen/Inner Diameter: 1.8 Inch
  • Depth: 5 Inch
BM-HM5-CC

  • Penile vacuum device

Bathmate - 05060140209560

Bathmate Hydromax 7 Crystal Clear
DX PRODUCTS LIMITED
Hydromax 7 CC
In Commercial Distribution

  • 05060140209591 ()
  • 05060140209560 ()
  • 05060140209584 ()
  • 05060140209577 ()

  • Lumen/Inner Diameter: 2 Inch
  • Depth: 7 Inch
BM-HM7-CC

  • Penile vacuum device

Bathmate - 05060140209324

Bathmate Hydroxtreme 5 Crystal Clear
DX PRODUCTS LIMITED
Hydroxtreme 5 CC
In Commercial Distribution

  • 05060140209331 ()
  • 05060140209324 ()

  • Lumen/Inner Diameter: 1.8 Inch
  • Depth: 5 Inch
BM-HX5-CC

  • Penile vacuum device

Bathmate - 05060140209249

Bathmate Hydroxtreme 9 Crystal Clear
DX PRODUCTS LIMITED
Hydroxtreme 9 CC
In Commercial Distribution

  • 05060140209256 ()
  • 05060140209249 ()

  • Lumen/Inner Diameter: 2.4 Inch
  • Depth: 9 Inch
BM-HX9-CC

  • Penile vacuum device

Bathmate - 05060140201021

Bathmate Hydromax 8 Crystal Clear
DX PRODUCTS LIMITED
Hydromax 8 CC
In Commercial Distribution

  • 05060140201083 ()
  • 05060140201021 ()

  • Lumen/Inner Diameter: 3 Inch
  • Depth: 8 Inch
BM-HM8-CC

  • Penile vacuum device

Bathmate - 05060140209362

Bathmate Hydromax 9 Crystal Clear
DX PRODUCTS LIMITED
Hydromax 9 CC
In Commercial Distribution

  • 05060140209379 ()
  • 05060140209362 ()

  • Lumen/Inner Diameter: 2.4 Inch
  • Depth: 9 Inch
BM-HM9-CC

  • Penile vacuum device

Bathmate - 05060140209287

Bathmate Hydroxtreme 7 Crystal Clear
DX PRODUCTS LIMITED
Hydroxtreme 7 CC
In Commercial Distribution

  • 05060140209294 ()
  • 05060140209287 ()

  • Lumen/Inner Diameter: 2 Inch
  • Depth: 7 Inch
BM-HX7-CC

  • Penile vacuum device

Bathmate - 05060140209225

Bathmate Hydroxtreme 11 Crystal Clear
DX PRODUCTS LIMITED
Hydroxtreme 11 CC
In Commercial Distribution

  • 05060140209232 ()
  • 05060140209225 ()

  • Lumen/Inner Diameter: 2.7 Inch
  • Depth: 11 Inch
BM-HX11-CC

  • Penile vacuum device

DIPLOMAT - 04047844127582

The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or more screws via the screw head and a rod using a force-fit or form-fit connection. Additional fixation elements, such as cross bars, hooks, connectors and washers, can also be used. The DIPLOMAT® pedicle screw system is applied temporarily to provide internal posterior stabilization until bone fusion in the lumbar or thoracic spine has taken place. The surgeon makes the final decision as to the indwelling time of the implant in the patient‘s body and the time when the implant is to be explanted. The pedicle screw system is implanted from a posterior approach. The implant is screwed into the vertebral body via the pedicle and it can be applied in a single segment or multiple segments. Implantation is facilitated by use of the specially developed accessories for inserting and positioning the implants. Only these accessories ensure safe use. Our product information provides further system-related information on the surgical method. If there are any preoperative uncertainties relating to the implant, information must be obtained from SIGNUS. Instruments specially developed by SIGNUS to ensure safe application are available for use with the implant system.
SIGNUS Medizintechnik GmbH
Parallel connector CC
In Commercial Distribution

  • 04047844127582 ()

  • Ø5,5mm/6,0mm
AB0163-55060

  • Bone-screw internal spinal fixation system connector

DIPLOMAT - 04047844127575

The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or more screws via the screw head and a rod using a force-fit or form-fit connection. Additional fixation elements, such as cross bars, hooks, connectors and washers, can also be used. The DIPLOMAT® pedicle screw system is applied temporarily to provide internal posterior stabilization until bone fusion in the lumbar or thoracic spine has taken place. The surgeon makes the final decision as to the indwelling time of the implant in the patient‘s body and the time when the implant is to be explanted. The pedicle screw system is implanted from a posterior approach. The implant is screwed into the vertebral body via the pedicle and it can be applied in a single segment or multiple segments. Implantation is facilitated by use of the specially developed accessories for inserting and positioning the implants. Only these accessories ensure safe use. Our product information provides further system-related information on the surgical method. If there are any preoperative uncertainties relating to the implant, information must be obtained from SIGNUS. Instruments specially developed by SIGNUS to ensure safe application are available for use with the implant system.
SIGNUS Medizintechnik GmbH
Parallel connector CC
In Commercial Distribution

  • 04047844127575 ()

  • Ø5,5mm/5,5mm
AB0163-55055

  • Bone-screw internal spinal fixation system connector

DIPLOMAT - 04047844127377

The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or more screws via the screw head and a rod using a force-fit or form-fit connection. Additional fixation elements, such as cross bars, hooks, connectors and washers, can also be used. The DIPLOMAT® pedicle screw system is applied temporarily to provide internal posterior stabilization until bone fusion in the lumbar or thoracic spine has taken place. The surgeon makes the final decision as to the indwelling time of the implant in the patient‘s body and the time when the implant is to be explanted. The pedicle screw system is implanted from a posterior approach. The implant is screwed into the vertebral body via the pedicle and it can be applied in a single segment or multiple segments. Implantation is facilitated by use of the specially developed accessories for inserting and positioning the implants. Only these accessories ensure safe use. Our product information provides further system-related information on the surgical method. If there are any preoperative uncertainties relating to the implant, information must be obtained from SIGNUS. Instruments specially developed by SIGNUS to ensure safe application are available for use with the implant system.
SIGNUS Medizintechnik GmbH
Parallel connector CC
In Commercial Distribution

  • 04047844127377 ()

  • Ø5,5mm/6,0mm
AB0163-55060/S

  • Spinal bone screw, non-bioabsorbable

DIPLOMAT - 04047844127360

The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or more screws via the screw head and a rod using a force-fit or form-fit connection. Additional fixation elements, such as cross bars, hooks, connectors and washers, can also be used. The DIPLOMAT® pedicle screw system is applied temporarily to provide internal posterior stabilization until bone fusion in the lumbar or thoracic spine has taken place. The surgeon makes the final decision as to the indwelling time of the implant in the patient‘s body and the time when the implant is to be explanted. The pedicle screw system is implanted from a posterior approach. The implant is screwed into the vertebral body via the pedicle and it can be applied in a single segment or multiple segments. Implantation is facilitated by use of the specially developed accessories for inserting and positioning the implants. Only these accessories ensure safe use. Our product information provides further system-related information on the surgical method. If there are any preoperative uncertainties relating to the implant, information must be obtained from SIGNUS. Instruments specially developed by SIGNUS to ensure safe application are available for use with the implant system.
SIGNUS Medizintechnik GmbH
Parallel connector CC
In Commercial Distribution

  • 04047844127360 ()

  • Ø5,5mm/5,5mm
AB0163-55055/S

  • Spinal bone screw, non-bioabsorbable

NA - 04582275250657

No Description
KONAN MEDICAL, INC.
CC 20 rc
Not in Commercial Distribution

  • 04582275250657 ()


  • Eye anterior segment analyser

Comfortox - 00817169023524

Comfortox Sterile syringes /with needle 3ml/cc 22gx1"
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
3ml/cc 22gx1"
In Commercial Distribution

  • 10817169023521 ()
  • 00817169023524 ()


  • Insulin syringe/needle, basic

Cerebralogik aEEG - 07290102932405

Electroencephalograph kit
BELMONT INSTRUMENT CORPORATION
Kit (CC PRO)
Not in Commercial Distribution

  • 07290102932405 ()
681-OPT-338

  • Patient monitoring system module, electroencephalographic

PERLA ® TL - 07640332470176

ROD CONNECTOR PARALLEL CLOSE/CLOSE 15mm
SpineArt SA
TLF-PC CC 15-S
In Commercial Distribution

  • 07640332470176 ()

  • 15mm
TLF-PC CC 15-S

  • Bone-screw internal spinal fixation system, sterile

PERLA ® TL - 07640332470169

ROD CONNECTOR PARALLEL CLOSE/CLOSE 11mm
SpineArt SA
TLF-PC CC 11-S
In Commercial Distribution

  • 07640332470169 ()

  • 11mm
TLF-PC CC 11-S

  • Bone-screw internal spinal fixation system, sterile

PERLA ® - 07640450864581

PARALLEL CONNECTOR CC-TO
SpineArt SA
CPF-PC CC TO-S
In Commercial Distribution

  • 07640450864581 ()
CPF-PC CC TO-S

  • Bone-screw internal spinal fixation system, sterile

IntelliSpace Critical Care and Anesthesia - 00884838085565

IntelliSpace Critical Care and Anesthesia
Philips Medical Systems Hsg
Intellispace CC & Anesthesia
Not in Commercial Distribution

  • 00884838085565 ()
866148

  • Medical equipment clinical data interfacing software

CipherOx CRI - 00860003025604

The CRI app provides the patient's individual-specific measure of the Compensatory Reserve Index.
FLASHBACK TECHNOLOGIES, INC.
CRI
In Commercial Distribution

  • 00860003025604 ()


  • Pulse oximeter probe, single-use

OvuSense - 05060508530121

M400 OvuFirst Starter Pack - M426 OvuFirst Skin Worn Sensor and M032 OvuSense App
VIO HEALTHTECH LIMITED
M400
In Commercial Distribution

  • 05060508530121 ()


  • Thermometric fertility analyser

MIR - 08052990321711

Smart Spirometer and Oximeter connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Spirobank Oxi
In Commercial Distribution

  • 08052990321711 ()


  • Expiratory peak flow meter, digital
  • Pulse oximeter

MIR - 08052990321704

Smart Spirometer and Oximeter connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Smart One Oxi
In Commercial Distribution

  • 08052990321704 ()


  • Expiratory peak flow meter, digital
  • Pulse oximeter

DRIVEMEDICAL - 00822383135809

Pressure PreventionGroup 1 Surfaces Product Description: APP Sys,Dlx,Variable Pressure,1/ea
Drive Devilbiss Healthcare
14001E
In Commercial Distribution

  • 00822383135809 ()
  • 50822383135804 ()


  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay system

FIBRIJET - 00815634020184

MANUAL ENDOSCOPIC SPRAY APP. W/MIX TIP 5MM X 40CM,11:1 RATIO
Micromedics, Inc.
SA-3667
In Commercial Distribution

  • 00815634020184 ()
  • 10815634020181 ()
  • 20815634020188 ()


  • Open-surgery adhesive/sealant applicator, dual-channel

Aaris Acrylic Intraocular lens(IOL) - 00884872015894

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageDataLoaded=false&pageMode=edit&deviceRecordKey=30865#
Aaren Scientific Inc.
EC-3
In Commercial Distribution

  • 00884872015894 ()


  • Posterior-chamber intraocular lens, pseudophakic

ZZ BASE NB-A-ICSC WP (Impression coping Screw) - D800BSFE2404

Compatible with Nobel Biocare NobelActive _ NobelReplace CC _ Nobel Parallel CC implants Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE2404
In Commercial Distribution

  • D800BSFE2404 ()


  • Dental implant suprastructure, temporary, preformed, reusable

ZZ BASE NB-A-ICSC CC 3.0 (Impression coping Screw) - D800BSFE2403

Compatible with Nobel Biocare NobelActive _ NobelReplace CC _ Nobel Parallel CC implants Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE2403
In Commercial Distribution

  • D800BSFE2403 ()


  • Dental implant suprastructure, temporary, preformed, reusable

ZZ BASE NB-A-ICSC RP (Impression coping Screw) - D800BSFE2402

Compatible with Nobel Biocare NobelActive _ NobelReplace CC _ Nobel Parallel CC implants Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE2402
In Commercial Distribution

  • D800BSFE2402 ()


  • Dental implant suprastructure, temporary, preformed, reusable

ZZ BASE NB-A-ICSC NP (Impression coping Screw) - D800BSFE2401

Compatible with Nobel Biocare NobelActive _ NobelReplace CC _ Nobel Parallel CC implants Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE2401
In Commercial Distribution

  • D800BSFE2401 ()


  • Dental implant suprastructure, temporary, preformed, reusable

.decimal Astroid Planning App 3.x - 00851147007120

The Astroid Planning App is a cloud based software used for treatment planning of proton radiation therapy treatments.
DECIMAL, INC.
3.x
In Commercial Distribution

  • 00851147007120 ()


  • Radiation therapy software

Orpheus CAST Mobile App Android OS - 07290017025124

A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025124 ()
ML-EG30001

  • Radiology information system application software

Orpheus CAST Mobile App iOS + Android - 07290017025100

A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025100 ()
MLL-EG30001

  • Radiology information system application software

Resilience – By Inner Armor App iOS - 07540191000630

No Description
Thought Technology Ltd.
SA4515
In Commercial Distribution

  • 07540191000630 ()


  • Psychophysiological biofeedback system

Eversense® NOW Mobile App iOS - 00817491021267

Eversense NOW Remote Monitoring mobile application (iOS) is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information.
SENSEONICS, INCORPORATED
FG-5901-01-300
In Commercial Distribution

  • 00817491021267 ()
FG-5901-01-300

  • Implantable glucose monitoring system

NovoGro Putty - 00863787000478

NovoGro Putty is intended to be hydrated with ultra-pure water and gently packed into bony voids or gaps of the skeletal system.
OSTEONOVUS, INC.
NGC10X
In Commercial Distribution

  • 00863787000478 ()

  • 10 cc


  • Bone matrix implant, synthetic, non-antimicrobial

NovoGro Putty - 00863787000461

NovoGro Putty is intended to be hydrated with ultra-pure water and gently packed into bony voids or gaps of the skeletal system.
OSTEONOVUS, INC.
NGC05X
In Commercial Distribution

  • 00863787000461 ()

  • 5 cc


  • Bone matrix implant, synthetic, non-antimicrobial

NovoGro Putty - 00863787000454

NovoGro Putty is intended to be hydrated with ultra-pure water and gently packed into bony voids or gaps of the skeletal system.
OSTEONOVUS, INC.
NGC025X
In Commercial Distribution

  • 00863787000454 ()

  • 2.5 cc


  • Bone matrix implant, synthetic, non-antimicrobial

NovoGro Putty - 00863787000423

NovoGro Putty is intended to be hydrated with ultra-pure water and gently packed into bony voids or gaps of the skeletal system.
OSTEONOVUS, INC.
NGC10
In Commercial Distribution

  • 00863787000423 ()

  • 10 cc


  • Bone matrix implant, synthetic, non-antimicrobial

NovoGro Putty - 00863787000416

NovoGro Putty is intended to be hydrated with ultra-pure water and gently packed into bony voids or gaps of the skeletal system.
OSTEONOVUS, INC.
NGC05
In Commercial Distribution

  • 00863787000416 ()

  • 5 cc


  • Bone matrix implant, synthetic, non-antimicrobial

NovoGro Putty - 00863787000409

NovoGro Putty is intended to be hydrated with ultra-pure water and gently packed into bony voids or gaps of the skeletal system.
OSTEONOVUS, INC.
NGC025
In Commercial Distribution

  • 00863787000409 ()

  • 2.5 cc


  • Bone matrix implant, synthetic, non-antimicrobial
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