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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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Abutment Base 1.75mm (X) - 00841549114311

Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into Abutment Bases which are screwed into endosseous implants.
STERNGOLD DENTAL LLC
904942
In Commercial Distribution

  • 00841549114311 ()


  • Dental implant suprastructure, permanent, preformed

OCI X T-Handle Driver - 09421028118262

A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
ENZTEC LIMITED
4252-2314
In Commercial Distribution

  • 09421028118262 ()
4252-2314

  • Orthopaedic implant impactor, reusable

OCI Trinket X M10x1.50-01 - 09421028118040

A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
ENZTEC LIMITED
4252-2337
In Commercial Distribution

  • 09421028118040 ()
4252-2337

  • Orthopaedic implant impactor, reusable

OCI Trinket X M8x1.25-01 - 09421028117982

A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
ENZTEC LIMITED
4252-2331
In Commercial Distribution

  • 09421028117982 ()
4252-2331

  • Orthopaedic implant impactor, reusable

Enztec Classic OCI X - 09421028117920

A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
ENZTEC LIMITED
4252-2310
In Commercial Distribution

  • 09421028117920 ()
4252-2310

  • Orthopaedic implant impactor, reusable

TI-MAX X CONTRA/HP - 04560264506701

No Description
NAKANISHI INC.
X85L
Not in Commercial Distribution

  • 04560264506701 ()


  • Dental surgical power tool motorized handpiece/set, electric

TI-MAX X CONTRA/HP - 04560264504608

No Description
NAKANISHI INC.
X25L
Not in Commercial Distribution

  • 04560264504608 ()


  • Dental surgical power tool motorized handpiece/set, electric

OCI Trinket X M8X0.75-01 - 09421028118071

A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
ENZTEC LIMITED
4252-2340
In Commercial Distribution

  • 09421028118071 ()
4252-2340

  • Orthopaedic implant impactor, reusable

X SERIES MONITOR/DEFIBRILLATOR - 00847946045470

X SERIES MONITOR/DEFIBRILLATOR, 3/5 LEAD, SPO2, NIBP, TEMP, CPR EXPANSION PACK, ETCO2, DMST
Zoll Medical Corporation
610-0121411-01
In Commercial Distribution

  • 00847946045470 ()


  • Noninvasive device battery charger
  • Internal defibrillation electrode, paediatric
  • Multifunction cardiac electrode, paediatric
  • Blood pressure cuff, single-use
  • External defibrillation electrode, paediatric, reusable
  • Internal defibrillation electrode, adult, reusable
  • Nasal oxygen cannula, carbon-dioxide-sampling
  • External defibrillation electrode, adult, single-use
  • Electrocardiographic electrode, single-use
  • Rechargeable professional automated external defibrillator

ACTICOAT 4" X 8" - 05000223449797

Silver-coated antimicrobial barrier dressing
SMITH & NEPHEW MEDICAL LIMITED
20201
In Commercial Distribution

  • 00040565121413 ()
  • 05000223449797 ()
  • 30040565121650 ()
20201

  • Wound-nonadherent dressing, absorbent, antimicrobial

ACTICOAT 4" X 4" - 05000223449766

Silver coated anti-mircobial barrier dressing
SMITH & NEPHEW MEDICAL LIMITED
20101
In Commercial Distribution

  • 00040565121352 ()
  • 05000223449766 ()
  • 30040565121643 ()
20101

  • Wound-nonadherent dressing, absorbent, antimicrobial

CICA-CARE 15CM X 12CM - 05000223441579

Silicone Gel Sheet. Treatment for red and raised, old and new scars
SMITH & NEPHEW MEDICAL LIMITED
66250706, 66250707
In Commercial Distribution

  • 05000223441814 ()
  • 05000223441579 ()
  • 05000223441821 ()
  • 05000223441654 ()
  • 05000223498351 ()
66250706, 66250707

  • Scar-management dressing, reusable

¼” x ¼” Pediatric Pack - TEMPORARY - 00607567211544

No Description
DATASCOPE CORP.
BO-T 52303
In Commercial Distribution

  • 00607567211544 ()
709000408

  • Cardiopulmonary bypass system blood tubing set

Celebrity X 4 Wheel - 00606509300018

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
Pride Mobility Products Corp
S4401/SC4401
In Commercial Distribution

  • 00606509300018 ()
N/A

  • Assistive scooter, electric-motor-driven

Celebrity X 3 Wheel - 00606509300001

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
Pride Mobility Products Corp
S4001/SC4001
In Commercial Distribution

  • 00606509300001 ()
N/A

  • Assistive scooter, electric-motor-driven

PRO Resins Arch X - 04260635981549

PRO Resins Arch X C1 1000g
DeltaMed GmbH
019.3261
In Commercial Distribution

  • 04260635981549 ()
019.3261

  • Dental appliance fabrication material, combination-material
  • Dental appliance fabrication material, resin
  • Temporary dental crown/bridge resin
  • Resin artificial teeth

PRO Resins Arch X - 04260635981532

PRO Resins Arch X Bleach 1000g
DeltaMed GmbH
019.3255
In Commercial Distribution

  • 04260635981532 ()
019.3255

  • Dental appliance fabrication material, combination-material
  • Dental appliance fabrication material, resin
  • Temporary dental crown/bridge resin
  • Resin artificial teeth

PRO Resins Arch X - 04260635981525

PRO Resins Arch X B1 1000g
DeltaMed GmbH
019.3260
In Commercial Distribution

  • 04260635981525 ()
019.3260

  • Dental appliance fabrication material, combination-material
  • Dental appliance fabrication material, resin
  • Temporary dental crown/bridge resin
  • Resin artificial teeth

PRO Resins Arch X - 04260635981518

PRO Resins Arch X A3.5 1000g
DeltaMed GmbH
019.3259
In Commercial Distribution

  • 04260635981518 ()
019.3259

  • Dental appliance fabrication material, combination-material
  • Dental appliance fabrication material, resin
  • Temporary dental crown/bridge resin
  • Resin artificial teeth

PRO Resins Arch X - 04260635981501

PRO Resins Arch X A3 1000g
DeltaMed GmbH
019.3258
In Commercial Distribution

  • 04260635981501 ()
019.3258

  • Dental appliance fabrication material, combination-material
  • Dental appliance fabrication material, resin
  • Temporary dental crown/bridge resin
  • Resin artificial teeth

PRO Resins Arch X - 04260635981495

PRO Resins Arch X A2 1000g
DeltaMed GmbH
019.3257
In Commercial Distribution

  • 04260635981495 ()
019.3257

  • Dental appliance fabrication material, combination-material
  • Dental appliance fabrication material, resin
  • Temporary dental crown/bridge resin
  • Resin artificial teeth

PRO Resins Arch X - 04260635981488

PRO Resins Arch X A1 1000g
DeltaMed GmbH
019.3256
In Commercial Distribution

  • 04260635981488 ()
019.3256

  • Dental appliance fabrication material, combination-material
  • Dental appliance fabrication material, resin
  • Temporary dental crown/bridge resin
  • Resin artificial teeth

PRO Resins Crown X - 04260635981471

PRO Resins Crown X C1 500g
DeltaMed GmbH
019.3252
In Commercial Distribution

  • 04260635981471 ()
019.3252

  • Dental appliance fabrication material, combination-material

PRO Resins Crown X - 04260635981464

PRO Resins Crown X Bleach 500g
DeltaMed GmbH
019.3246
In Commercial Distribution

  • 04260635981464 ()
019.3246

  • Dental appliance fabrication material, combination-material

PRO Resins Crown X - 04260635981457

PRO Resins Crown X B1 500g
DeltaMed GmbH
019.3251
In Commercial Distribution

  • 04260635981457 ()
019.3251

  • Dental appliance fabrication material, combination-material

PRO Resins Crown X - 04260635981440

PRO Resins Crown X A3.5 500g
DeltaMed GmbH
019.3250
In Commercial Distribution

  • 04260635981440 ()
019.3250

  • Dental appliance fabrication material, combination-material

PRO Resins Crown X - 04260635981433

PRO Resins Crown X A3 500g
DeltaMed GmbH
019.3249
In Commercial Distribution

  • 04260635981433 ()
019.3249

  • Dental appliance fabrication material, combination-material

PRO Resins Crown X - 04260635981426

PRO Resins Crown X A2 500g
DeltaMed GmbH
019.3248
In Commercial Distribution

  • 04260635981426 ()
019.3248

  • Dental appliance fabrication material, combination-material

PRO Resins Crown X - 04260635981419

PRO Resins Crown X A1 500g
DeltaMed GmbH
019.3247
In Commercial Distribution

  • 04260635981419 ()
019.3247

  • Dental appliance fabrication material, combination-material

PRO Resins Base X - 04260635981358

PRO Resins Base X pink-transparent 1000g
DeltaMed GmbH
019.3327
In Commercial Distribution

  • 04260635981358 ()
019.3327

  • Dental appliance fabrication material, resin

PRO Resins Base X - 04260635981341

PRO Resins Base X pink-opaque 1000g
DeltaMed GmbH
019.3326
In Commercial Distribution

  • 04260635981341 ()
019.3326

  • Dental appliance fabrication material, resin

PRO Resins Tooth X - 04260635981334

PRO Resins Tooth X A3 1000g
DeltaMed GmbH
019.3230
In Commercial Distribution

  • 04260635981334 ()
019.3230

  • Resin artificial teeth

PRO Resins Tooth X - 04260635981327

PRO Resins Tooth X A2 1000g
DeltaMed GmbH
019.3229
In Commercial Distribution

  • 04260635981327 ()
019.3229

  • Resin artificial teeth

PRO Resins Tooth X - 04260635981310

PRO Resins Tooth X A1 1000g
DeltaMed GmbH
019.3228
In Commercial Distribution

  • 04260635981310 ()
019.3228

  • Resin artificial teeth

PRO Resins Crown X - 04260635981303

PRO Resins Crown X C1 1000g
DeltaMed GmbH
019.3225
In Commercial Distribution

  • 04260635981303 ()
019.3225

  • Dental appliance fabrication material, combination-material

PRO Resins Crown X - 04260635981297

PRO Resins Crown X Bleach 1000g
DeltaMed GmbH
019.3219
In Commercial Distribution

  • 04260635981297 ()
019.3219

  • Dental appliance fabrication material, combination-material

PRO Resins Crown X - 04260635981280

PRO Resins Crown X B1 1000g
DeltaMed GmbH
019.3224
In Commercial Distribution

  • 04260635981280 ()
019.3224

  • Dental appliance fabrication material, combination-material

PRO Resins Crown X - 04260635981273

PRO Resins Crown X A3,5 1000g
DeltaMed GmbH
019.3223
In Commercial Distribution

  • 04260635981273 ()
019.3223

  • Dental appliance fabrication material, combination-material

PRO Resins Crown X - 04260635981266

PRO Resins Crown X A3 1000g
DeltaMed GmbH
019.3222
In Commercial Distribution

  • 04260635981266 ()
019.3222

  • Dental appliance fabrication material, combination-material

PRO Resins Crown X - 04260635981259

PRO Resins Crown X A2 1000g
DeltaMed GmbH
019.3221
In Commercial Distribution

  • 04260635981259 ()
019.3221

  • Dental appliance fabrication material, combination-material

PRO Resins Crown X - 04260635981242

PRO Resins Crown X A1 1000g
DeltaMed GmbH
019.3220
In Commercial Distribution

  • 04260635981242 ()
019.3220

  • Dental appliance fabrication material, combination-material

2.8MM X 230MM DRILL - 00887868091735

No Description
Biomet Orthopedics, LLC
14-401435
In Commercial Distribution

  • 00887868091735 ()
14-401435

  • Fluted surgical drill bit, single-use

2.0MM X 230MM DRILL - 00887868091728

No Description
Biomet Orthopedics, LLC
14-401434
In Commercial Distribution

  • 00887868091728 ()
14-401434

  • Fluted surgical drill bit, single-use

2.8MM X 190MM DRILL - 00887868091711

No Description
Biomet Orthopedics, LLC
14-401433
In Commercial Distribution

  • 00887868091711 ()
14-401433

  • Fluted surgical drill bit, single-use

2.0MM X 190MM DRILL - 00887868091704

No Description
Biomet Orthopedics, LLC
14-401432
In Commercial Distribution

  • 00887868091704 ()
14-401432

  • Fluted surgical drill bit, single-use

2.8MM X 150MM DRILL - 00887868091698

No Description
Biomet Orthopedics, LLC
14-401431
In Commercial Distribution

  • 00887868091698 ()
14-401431

  • Biopsy drill bit

2.0MM X 150MM DRILL - 00887868091681

No Description
Biomet Orthopedics, LLC
14-401430
In Commercial Distribution

  • 00887868091681 ()
14-401430

  • Biopsy drill bit

25 X 25 COVERSLIPS - 00810119678256

No Description
BIOGENEX LABORATORIES
XT122-YQK
In Commercial Distribution

  • 00810119678256 ()
XT122-YQK

  • Microscope slide coverslip IVD

25 X 40 COVERSLIPS - 00810119677938

No Description
BIOGENEX LABORATORIES
XT118-YRK
In Commercial Distribution

  • 00810119677938 ()
XT118-YRK

  • Microscope slide coverslip IVD

Beautifil Flow Plus X - E235YN23370

BEAUTIFIL FLOW PLUS X F03CV
SHOFU DENTAL CORPORATION
YN2337
In Commercial Distribution

  • E235YN23370 ()
YN2337

  • Dental composite resin
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