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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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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 - 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 - 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

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 - 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 - 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

NA - 04582275250657

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

  • 04582275250657 ()


  • Eye anterior segment analyser

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

HYPE stem - 03662200019663

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

  • 03662200019663 ()


  • 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 - 03662200019601

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

  • 03662200019601 ()


  • 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

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

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

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

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

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

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

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
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