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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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SET PURE C&G BCT CROS IX BG
Ws Audiology Usa, Inc.
CROS Pure C&G BCT IX
In Commercial Distribution

  • 05714880265293 ()
21044359

  • Contralateral hearing unit
ClikRay (TM) K-Series (K1, K2, & KV) + Two "G"
CLIKTECH LLC
001-213
In Commercial Distribution

  • 00856200001213 ()
001-213

  • Dental x-ray film holder, reusable
HEPRO.US Syringe 20ml/cc 18 G x 1
HEPRO.US INC.
SINGLE - 20ml/cc 18Gx1
In Commercial Distribution

  • 00854427007810 ()


  • General-purpose syringe, single-use
Personal Lubricant NET WT 4 OZ (113 g)
MEIJER, INC.
7W9266EC1
In Commercial Distribution

  • 10719283168341 ()
  • 00719283168344 ()

  • Weight: 113 Gram


  • Vaginal lubricant
29 G 12.7 mm insulin syringe 1 ML
TILCO TRADING PTE. LTD.
29 G 12.7 mm insulin syringe 1 ml
In Commercial Distribution

  • 15060665920503 ()
  • 05060665920506 ()
  • 25060665920500 ()

  • Total Volume: 1 Milliliter


  • Medication transfer set
31 G 8 mm insulin syringe 1 ml
TILCO TRADING PTE. LTD.
31 G 8 mm insulin syringe
In Commercial Distribution

  • 15060665920497 ()
  • 05060665920490 ()
  • 25060665920494 ()

  • Total Volume: 1 Milliliter


  • Medication transfer set
Lumipulse G pTau 217 Plasma Calibrators 1x5C, IVD-US
Fujirebio Europe
81557
In Commercial Distribution

  • 05414470815579 ()

  • 5 bottles per unit; 1.5 mL per bottle


  • Tau protein IVD, calibrator
IPS Empress Add-On 770°C1418°F 20 g
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
564080
Not in Commercial Distribution

  • DIVO5640801 ()
564080

  • Dental appliance fabrication material, ceramic
RBN-114SS, F/G, Sterile PN 74441-01M Customer # 0019886
RANFAC CORP.
11GA X 4"
In Commercial Distribution

  • 00850075308002 ()
  • 10850075308009 ()
  • 20850075308006 ()

  • Length: 4 Inch
  • Needle Gauge: 11 Gauge
RBN-114SS

  • Bone marrow biopsy needle, single-use
IPS Empress E.V. Mod. 1 g sky blue
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
579414
Not in Commercial Distribution

  • DIVO5794141 ()
  • DIVO5794142 ()
579414

  • Dental appliance fabrication material, ceramic
IPS e.max Ceram Glaze Powder FLUO 5 g
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
597045
In Commercial Distribution

  • DIVO5970451 ()
597045

  • Dental appliance fabrication material, ceramic
IPS Empress E.V. Mod. 1 g basic red
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
579416
Not in Commercial Distribution

  • DIVO5794161 ()
  • DIVO5794162 ()
579416

  • Dental appliance fabrication material, ceramic
IPS Empress E.V. Incisal Opal 20 g LT
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
579388
Not in Commercial Distribution

  • DIVO5793881 ()
579388

  • Dental appliance fabrication material, ceramic
Signia Insio C&G 2AX ITE Hearing Aid
Ws Audiology Usa, Inc.
Insio C&G 2AX ITE
In Commercial Distribution

  • 05714880129519 ()
21006355

  • Air-conduction hearing aid, in-the-ear
Signia Insio C&G 1AX ITE Hearing Aid
Ws Audiology Usa, Inc.
Insio C&G 1AX ITE
In Commercial Distribution

  • 05714880129502 ()
21006356

  • Air-conduction hearing aid, in-the-ear
Signia Insio C&G 2AX ITC Hearing Aid
Ws Audiology Usa, Inc.
Insio C&G 2AX ITC
In Commercial Distribution

  • 05714880129489 ()
21006358

  • Air-conduction hearing aid, in-the-ear
Signia Insio C&G 1AX ITC Hearing Aid
Ws Audiology Usa, Inc.
Insio C&G 1AX ITC
In Commercial Distribution

  • 05714880129496 ()
21006357

  • Air-conduction hearing aid, in-the-ear
Miracle Mix® 17 g alloy powder btl.
Gc America Inc.
000123
In Commercial Distribution

  • 14548161329460 ()

  • Weight: 17 Gram
000123

  • Glass ionomer dental cement
GC Fuji ORTHO™ 40 g powder btl
Gc America Inc.
000209
In Commercial Distribution

  • 24548161293676 ()
  • 14548161293679 ()

  • Weight: 40 Gram
000209

  • Glass ionomer dental cement
KALORE™ Syringes (2 mL/4 g) CVT
Gc America Inc.
003597
In Commercial Distribution

  • 14548161293310 ()

  • Total Volume: 2 Milliliter
003597

  • Dental composite resin
KALORE™ Syringes (2 mL/4 g) GT
Gc America Inc.
003596
In Commercial Distribution

  • 14548161293303 ()

  • Total Volume: 2 Milliliter
003596

  • Dental composite resin
KALORE™ Syringes (2 mL/4 g) NT
Gc America Inc.
003595
In Commercial Distribution

  • 14548161293297 ()

  • Total Volume: 2 Milliliter
003595

  • Dental composite resin
KALORE™ Syringes (2 mL/4 g) CT
Gc America Inc.
003594
In Commercial Distribution

  • 14548161293280 ()

  • Total Volume: 2 Milliliter
003594

  • Dental composite resin
KALORE™ Syringes (2 mL/4 g) DT
Gc America Inc.
003593
In Commercial Distribution

  • 14548161293273 ()

  • Total Volume: 2 Milliliter
003593

  • Dental composite resin
KALORE™ Syringes (2 mL/4 g) WT
Gc America Inc.
003592
In Commercial Distribution

  • 14548161293266 ()

  • Total Volume: 2 Milliliter
003592

  • Dental composite resin
KALORE™ Syringes (2 mL/4 g) XBW
Gc America Inc.
003591
In Commercial Distribution

  • 14548161293259 ()

  • Total Volume: 2 Milliliter
003591

  • Dental composite resin
KALORE™ Syringes (2 mL/4 g) BW
Gc America Inc.
003590
In Commercial Distribution

  • 14548161293242 ()

  • Total Volume: 2 Milliliter
003590

  • Dental composite resin
KALORE™ Syringes (2 mL/4 g) CVD
Gc America Inc.
003589
In Commercial Distribution

  • 14548161293235 ()

  • Total Volume: 2 Milliliter
003589

  • Dental composite resin
KALORE™ Syringes (2 mL/4 g) CV
Gc America Inc.
003588
In Commercial Distribution

  • 14548161293228 ()

  • Total Volume: 2 Milliliter
003588

  • Dental composite resin
KALORE™ Syringes (2 mL/4 g) D2
Gc America Inc.
003587
In Commercial Distribution

  • 14548161293211 ()

  • Total Volume: 2 Milliliter
003587

  • Dental composite resin
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