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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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Sklar® - 10649111301247

THOMAS WAX CARVER D/E #5
SKLAR CORPORATION
48-296
In Commercial Distribution

  • 10649111301247 ()


  • Dental wax carver

Sklar® - 10649111300110

WAX CARVER THOMAS #4 D/E
SKLAR CORPORATION
48-288
In Commercial Distribution

  • 10649111300110 ()


  • Dental wax carver

Sklar - 10649111337505

CURETTE EXCA D/E 1-3 1.5X2.5MM
SKLAR CORPORATION
97-0536
In Commercial Distribution

  • 10649111337505 ()


  • General-purpose curette

Sklar - 10649111336768

CURETTE EXCA D/E 1-2 1.5X2MM
SKLAR CORPORATION
97-0532
In Commercial Distribution

  • 10649111336768 ()


  • General-purpose curette

Sklar® - 10649111390357

CENSITRAC READY MEYERDING RETR "E" 7"
SKLAR CORPORATION
22-8214C
In Commercial Distribution

  • 10649111390357 ()


  • Hand-held surgical retractor, reusable

MULTIX SOLUTIONS - G0353044970000

MULTIFUNCTIONAL MULTIX BELLAVISTA 1000 E TROLLEY
MULTIX SOLUTIONS SRL
X3
In Commercial Distribution

  • G0353044970000 ()
304.497.000

  • Electromechanical device/system transport trolley

MULTIX SOLUTIONS SRL - G035000NKV3300

NKV330 X1 TROLLEY + ACCESSORIES - E/X1-330.000
MULTIX SOLUTIONS SRL
X1
In Commercial Distribution

  • G035000NKV3300 ()
000NKV330

  • Electromechanical device/system transport trolley

Sklar® - 10649111178757

VOLKMAN BONE CURR D E 8"
SKLAR CORPORATION
40-7280
In Commercial Distribution

  • 10649111178757 ()


  • Bone curette, reusable

Sklar® - 10649111174322

VOLKMAN BONE CURR D E 5"
SKLAR CORPORATION
40-7250
In Commercial Distribution

  • 10649111174322 ()


  • Bone curette, reusable

Sklar® - 10649111214462

MANNERFELT TENDON HOOK D/E 6"
SKLAR CORPORATION
47-3540
In Commercial Distribution

  • 10649111214462 ()


  • Soft-tissue surgical hook, reusable

Vision 2 - 00817978025405

E. coli O 28 : K 73
PRO-LAB, INCORPORATED
PLA540
In Commercial Distribution

  • 00817978025405 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025375

E. coli (O&K) Polyvalent III
PRO-LAB, INCORPORATED
PLA537
In Commercial Distribution

  • 00817978025375 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025368

E. coli O 128: K 67
PRO-LAB, INCORPORATED
PLA536
In Commercial Distribution

  • 00817978025368 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025351

E. coli O 127: K 63
PRO-LAB, INCORPORATED
PLA535
In Commercial Distribution

  • 00817978025351 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025344

E. coli O 126: K 71
PRO-LAB, INCORPORATED
PLA534
In Commercial Distribution

  • 00817978025344 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025337

E. coli O 125: K 70
PRO-LAB, INCORPORATED
PLA533
In Commercial Distribution

  • 00817978025337 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025320

E. coli O 124: K 72
PRO-LAB, INCORPORATED
PLA532
In Commercial Distribution

  • 00817978025320 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025313

E. coli O 86: K 61
PRO-LAB, INCORPORATED
PLA531
In Commercial Distribution

  • 00817978025313 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025306

E. coli (O&K) Polyvalent II
PRO-LAB, INCORPORATED
PLA530
In Commercial Distribution

  • 00817978025306 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025290

E. coli O 119: K 169
PRO-LAB, INCORPORATED
PLA529
In Commercial Distribution

  • 00817978025290 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025276

E. coli O 111: K 58
PRO-LAB, INCORPORATED
PLA527
In Commercial Distribution

  • 00817978025276 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025269

E. coli O 78: K 80
PRO-LAB, INCORPORATED
PLA526
In Commercial Distribution

  • 00817978025269 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025252

E. coli O 55: K 59
PRO-LAB, INCORPORATED
PLA525
In Commercial Distribution

  • 00817978025252 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025245

E. coli O 44: K 74
PRO-LAB, INCORPORATED
PLA524
In Commercial Distribution

  • 00817978025245 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025238

E. coli O 25: K 60
PRO-LAB, INCORPORATED
PLA523
In Commercial Distribution

  • 00817978025238 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025221

E. coli O 25: K 11
PRO-LAB, INCORPORATED
PLA522
In Commercial Distribution

  • 00817978025221 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025214

E. coli (O&K) Polyvalent I
PRO-LAB, INCORPORATED
PLA521
In Commercial Distribution

  • 00817978025214 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Sklar - 10649111016868

PENNYPACKER DISSECTOR D/E 9 IN
SKLAR CORPORATION
47-2269
In Commercial Distribution

  • 10649111016868 ()


  • Open-surgery dissector

Nasal-Aire II - 00833224006103

Nasal-Aire II Petite Cannula - Size E
Innomed Technologies Inc
PE415
In Commercial Distribution

  • 50833224006108 ()
  • 30833224006104 ()
  • 00833224006103 ()
PE415

  • CPAP/BPAP nasal mask, reusable

NA - 03596010252227

E/S ELECTRODE 90DEG BL (10BX)
Smith & Nephew, Inc.
7205443
In Commercial Distribution

  • 23596010252221 ()
  • 03596010252227 ()
7205443

  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

NA - 03596010252197

E/S SWITCHPEN (5/BOX) (CE/ )
Smith & Nephew, Inc.
7205440
In Commercial Distribution

  • 23596010252191 ()
  • 03596010252197 ()
7205440

  • Electrosurgical handpiece, single-use

CARDIOSAVE HYBRID W/ E/F PLUG - 10607567108414

CARDIOSAVE HYBRID W/ E/F PLUG
Datascope Corp.
0998-00-0800-55
In Commercial Distribution

  • 10607567108414 ()
0998-00-0800-55

  • Intra-aortic balloon pump

Dalbo®-B - 07640166513773

Dalbo®-B Male part E
Cendres+Métaux SA
050423
In Commercial Distribution

  • 07640166513773 ()
050423

  • Dental anchor

Dalbo®-Z - 07640166513698

Dalbo®-Z Male part E
Cendres+Métaux SA
050272
In Commercial Distribution

  • 07640166513698 ()
050272

  • Dental anchor

Dalbo®-S - 07640166514008

Dalbo®-S Female part E
Cendres+Métaux SA
051513
Not in Commercial Distribution

  • 07640166514008 ()
051513

  • Sliding dental precision attachment

Dalbo®-B - 07640166513995

Dalbo®-B Female part E
Cendres+Métaux SA
051511
In Commercial Distribution

  • 07640166513995 ()
051511

  • Dental anchor

Mini-Dalbo® - 07640166513834

Mini-Dalbo® Matrize E 083.01.2 0054
Cendres+Métaux SA
050698
Not in Commercial Distribution

  • 07640166513834 ()
050698

  • Sliding dental precision attachment

DM Converter – TiN coated - 07630971256354

DM Converter E/DMC - TiN coated
Medacta International SA
01.32.3844CF
In Commercial Distribution

  • 07630971256354 ()


  • Metallic acetabular liner

Sklar - 10649111451409

CONVERSE ALAR RETR D/E SHARP
SKLAR CORPORATION
41-1397
In Commercial Distribution

  • 10649111451409 ()


  • Hand-held surgical retractor, reusable

Midwest® E Plus - E2768752200

Midwest® E Plus 6:1
SIRONA Dental Systems GmbH
875220
In Commercial Distribution

  • E2768752200 ()


  • Dental power tool handpiece motorless component
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