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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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Trimedyne® Reposable OmniTip™ Switchable Tip - 20° - M47320475MHP0

Multiuse Switchable Tip, Omni HP System, 20 degree
TRIMEDYNE, INC.
20475M-HP
In Commercial Distribution

  • M47320475MHP1 ()
  • M47320475MHP0 ()
20475M-HP

  • General/multiple surgical laser system beam guide, reusable

Trimedyne® OmniTip™ Switchable Tip - 20° - M47320475HP0

Tip, Switchable, Omni HP System, 20 degree
TRIMEDYNE, INC.
20475-HP
In Commercial Distribution

  • M47320475HP1 ()
  • M47320475HP0 ()
20475-HP

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® OmniTip™ Switchable Tip - Straight - M47320474HP0

Tip, Switchable, Omni HP System, 0 degree
TRIMEDYNE, INC.
20474-HP
In Commercial Distribution

  • M47320474HP1 ()
  • M47320474HP0 ()
20474-HP

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® OmniTip™ 25 cm Side Firing Laser Needle - M47320462HP0

SwitchTip, Sidefire, 25cm
TRIMEDYNE, INC.
20462-HP
In Commercial Distribution

  • M47320462HP1 ()
  • M47320462HP0 ()
20462-HP

  • General/multiple surgical laser system beam guide, single-use

Mynx Ace Vascular Closure Device (6F/7F) - M465MX67400

Mynx Ace Vascular Closure Device (6F/7F)
Access Closure, Inc.
MX6740
In Commercial Distribution

  • M465MX67400 ()
  • M465MX67401 ()

  • Catheter Gauge: 6 French
MX6740

  • Wound hydrogel dressing, non-antimicrobial

MynxGrip Vascular Closure Device (6F/7F) - M465MX67210

MynxGrip Vascular Closure Device (6F/7F)
Access Closure, Inc.
MX6721
In Commercial Distribution

  • M465MX67210 ()
  • M465MX67211 ()

  • Catheter Gauge: 6 French
MX6721

  • Wound hydrogel dressing, non-antimicrobial

MynxGrip Vascular Closure Device (5F) - M465MX50210

MynxGrip Vascular Closure Device (5F)
Access Closure, Inc.
MX5021
In Commercial Distribution

  • M465MX50210 ()
  • M465MX50211 ()

  • Catheter Gauge: 5 French
MX5021

  • Wound hydrogel dressing, non-antimicrobial

SHARP™ - M595S5120

SHARP™ Heavy-Body Premium Hydrophilic VPS Impression Material
PARKELL, INC.
S512
Not in Commercial Distribution

  • M595S5121 ()
  • M595S5120 ()
S512

  • Silicone dental impression material

SHARP™ - M595S5110

SHARP™ Medium Body Premium Hydrophilic VPS Impression Material
PARKELL, INC.
S511
Not in Commercial Distribution

  • M595S5111 ()
  • M595S5110 ()
S511

  • Silicone dental impression material

SHARP™ - M595S5100

SHARP™ Wash Premium Hydrophilic VPS Impression Material
PARKELL, INC.
S510
Not in Commercial Distribution

  • M595S5101 ()
  • M595S5100 ()
S510

  • Silicone dental impression material

Cinch™ - M595S463S0

Quick Cinch™ Heavy Body in Split-Cartridge System (4-Cartridges & Mixing Tips)
PARKELL, INC.
S463S
Not in Commercial Distribution

  • M595S463S1 ()
  • M595S463S0 ()
S463S

  • Silicone dental impression material

Cinch™ - M595S461S0

Quick Cinch™ Light-Body in Split-Cartridge System (4-Cartridges & Mixing Tips)
PARKELL, INC.
S461S
Not in Commercial Distribution

  • M595S461S1 ()
  • M595S461S0 ()
S461S

  • Silicone dental impression material

Cinch™ - M595S460S0

Cinch™ Light Split-Cartridge System (4-Cartridges & Mixing Tips)
PARKELL, INC.
S460S
Not in Commercial Distribution

  • M595S460S1 ()
  • M595S460S0 ()
S460S

  • Silicone dental impression material

Blu-Mousse® - M595S457S0

Super-Fast Blu-Mousse® Split-Cartridge System
PARKELL, INC.
S457S
Not in Commercial Distribution

  • M595S457S1 ()
  • M595S457S0 ()
S457S

  • Silicone dental impression material

Blu-Mousse® - M595S4570

Super-Fast Blu-Mousse® Standard-Cartridge System
PARKELL, INC.
S457
Not in Commercial Distribution

  • M595S4571 ()
  • M595S4570 ()
S457

  • Silicone dental impression material

Cinch™ - M595S456S0

Cinch™ Putty Split-Cartridge System (4-Cartridges & Tips)
PARKELL, INC.
S454S
Not in Commercial Distribution

  • M595S456S1 ()
  • M595S456S0 ()
S454S

  • Silicone dental impression material

Green-Mousse® - M595S455S0

Green-Mousse® In Split-Cartridge System
PARKELL, INC.
S455S
Not in Commercial Distribution

  • M595S455S1 ()
  • M595S455S0 ()
S455S

  • Silicone dental impression material

Cinch™ - M595S454S0

Cinch™ Platinum Medium Body In Split-Cartridge No Clog Auto Mix System (4-Cartridges & Tips)
PARKELL, INC.
S454S
Not in Commercial Distribution

  • M595S454S1 ()
  • M595S454S0 ()
S454S

  • Silicone dental impression material

Cinch™ - M595S453S0

Cinch™ 90 Medium-Body Split-Cartridge System (4-Cartridges & Tips)
PARKELL, INC.
S453S
Not in Commercial Distribution

  • M595S453S1 ()
  • M595S453S0 ()
S453S

  • Silicone dental impression material

Blu-Mousse® - M595S448S0

Peppermint Super-Fast Blu-Mousse® In Split-Cartridge System
PARKELL, INC.
S448S
Not in Commercial Distribution

  • M595S448S1 ()
  • M595S448S0 ()
S448S

  • Silicone dental impression material

Blu-Mousse® - M595S440S0

Blu-Mousse® 60 In Split-Cartridge
PARKELL, INC.
S440S
Not in Commercial Distribution

  • M595S440S1 ()
  • M595S440S0 ()
S440S

  • Silicone dental impression material

Blu-Mousse® - M595S438S0

Classic Blu-Mousse® In Split-Cartridge System
PARKELL, INC.
S438S
Not in Commercial Distribution

  • M595S438S1 ()
  • M595S438S0 ()
S438S

  • Silicone dental impression material

Blu-Mousse® - M595S4380

Classic Blu-Mousse® Standard-Cartridge System
PARKELL, INC.
S438
Not in Commercial Distribution

  • M595S4381 ()
  • M595S4380 ()
S438

  • Silicone dental impression material

Blu-Mousse® - M595S437S0

Peppermint Classic Blu-Mousse® In Split-Cartridge System
PARKELL, INC.
S437S
Not in Commercial Distribution

  • M595S437S1 ()
  • M595S437S0 ()
S437S

  • Silicone dental impression material

Cinch™ - M595S4350

Cinch™ Platinum Tubes (Contains: 2-Tubes Base & 2-Tubes Catalyst)
PARKELL, INC.
S435
Not in Commercial Distribution

  • M595S4351 ()
  • M595S4350 ()
S435

  • Silicone dental impression material

Absolute Dentin™ - M595S3060

10ml. Blue Absolute Dentin™ (2 Cartridges; 20ml. Total)
PARKELL, INC.
S306
Not in Commercial Distribution

  • M595S3061 ()
  • M595S3060 ()
S306

  • Dental composite resin

Absolute Dentin™ - M595S3050

10ml. Tooth Shade Absolute Dentin™ (2 Cartridges; 20ml. Total)
PARKELL, INC.
S305
Not in Commercial Distribution

  • M595S3051 ()
  • M595S3050 ()
S305

  • Dental composite resin

Absolute Dentin™ - M595S3040

10ml. Artic White Absolute Dentin™ (2 Cartridges; 20ml. Total)
PARKELL, INC.
S304
Not in Commercial Distribution

  • M595S3041 ()
  • M595S3040 ()
S304

  • Dental composite resin

Integra™ - M595D6810

Replacement Reservoir Bottles for Integra™ Scaler (2 Bottles & Caps)
PARKELL, INC.
D681
Not in Commercial Distribution

  • M595D6811 ()
  • M595D6810 ()
D681

  • Ultrasonic dental scaling/debridement system

NA - M595D619GC0

Universal Ground Clip (Pkg. of 2 pcs.)
PARKELL, INC.
D619GC
Not in Commercial Distribution

  • M595D619GC1 ()
  • M595D619GC0 ()
D619GC

  • Endodontic apex locator

PerioSonic® - M595D5810

Empty Bottles for PerioSonic Irrigator D583 & D584 (6 Bottles & Caps)
PARKELL, INC.
D581
Not in Commercial Distribution

  • M595D5811 ()
  • M595D5810 ()
D581

  • Ultrasonic dental scaling/debridement system

Aurora™ - M595D5480

Aurora™ S3 Tacking Lens D546 (Pkg. of 5 pcs.)
PARKELL, INC.
D548
Not in Commercial Distribution

  • M595D5481 ()
  • M595D5480 ()
D548

  • Dental/surgical polymerization lamp

Aurora™ - M595D5470

Aurora™ S3 Curing Lens D546 (Pkg. of 10 pcs.)
PARKELL, INC.
D547
Not in Commercial Distribution

  • M595D5471 ()
  • M595D5470 ()
D547

  • Dental/surgical polymerization lamp

Aurora™ - M595D5430

Tacking Lens for Aurora™ D540 (Pkg. of 5 pcs.)
PARKELL, INC.
D543
Not in Commercial Distribution

  • M595D5431 ()
  • M595D5430 ()
D543

  • Dental/surgical polymerization lamp

Aurora™ - M595D5410

Curing Lens for Aurora™ D540 (Pkg. of 10 pcs.)
PARKELL, INC.
D541
Not in Commercial Distribution

  • M595D5411 ()
  • M595D5410 ()
D541

  • Dental/surgical polymerization lamp

ELBOW CONNECTOR - M648C1002020

SMOKE EVACUATION TUBING CONNECTOR
OBP CORPORATION
C100202
In Commercial Distribution

  • M648C1002021 ()
  • M648C1002020 ()


  • Hand-held surgical retractor, single-use

FLUID MANAGEMENT PACK - M648C0502000

FLUID MANAGEMENT PACK
OBP CORPORATION
C020500
In Commercial Distribution

  • M648C0502001 ()
  • M648C0502000 ()


  • Urological surgical procedure kit, medicated, single-use

ENDOSCOPIC SEAL - M648C0100130

ENDOSCOPIC SEAL GYN 1 SIZE FITS ALL
OBP CORPORATION
C010013
In Commercial Distribution

  • M648C0100131 ()
  • M648C0100130 ()
C010013

  • Endoscope working-channel seal

SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ GYN - M648C0100110

C010011 SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ GYN (Customer REF 26153EAU/10)
OBP CORPORATION
C010011
In Commercial Distribution

  • M648C0100111 ()
  • M648C0100110 ()


  • Endoscope working-channel seal

Otomedics - M633S3816500

U-Tube 1.35mm ID
JEDMED INSTRUMENT COMPANY
S381650
In Commercial Distribution

  • M633S3816500 ()
  • M6333816501 ()

  • Lumen/Inner Diameter: 1.35 Millimeter
S381650

  • Tympanostomy tube
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