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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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Retreat GRP Cannules
HENRY SCHEIN, INC.
5700346
In Commercial Distribution

  • 10304040025984 ()
  • 00304040025987 ()
5700346

  • Dental material injection cannula, reusable
Retreat GRP Capsule
HENRY SCHEIN, INC.
5700348
In Commercial Distribution

  • 10304040025960 ()
  • 00304040025963 ()

  • capsules containing 1g of EXPASYL paste
  • Weight: 1 Gram
5700348

  • Gingival retraction kit
XEROFORM 1 X 8 IN
Cardinal Health 200, LLC
14-1302A
In Commercial Distribution

  • 50198956074987 ()
  • 10198956074989 ()
14-1302A

  • General surgical procedure kit, non-medicated, single-use
Pointe Phencyclidine (PCP) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Phencyclidine (PCP) Reagent Set is intended for the qualitative and semi-quantitative determination of PCP in human urine at a cutoff value of 25 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-PH0020-100
In Commercial Distribution

  • 00811727016454 ()
60-PH0020-100

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
Pointe Phencyclidine (PCP) Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Phencyclidine (PCP) Reagent Set is intended for the qualitative and semi-quantitative determination of PCP in human urine at a cutoff value of 25 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-PH0020-1L
In Commercial Distribution

  • 00811727016461 ()
60-PH0020-1L

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL.
LIN-ZHI INTERNATIONAL, INC.
0011
In Commercial Distribution

  • B07600110 ()
0011

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.
LIN-ZHI INTERNATIONAL, INC.
0010
In Commercial Distribution

  • B07600100 ()
0010

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
VeraPlug Flow Nonsterile Bulk - X-Large
KRISHNA IMPORTS INC
BVF-1004
In Commercial Distribution

  • 00810799030245 ()
  • 00810799030207 ()
BVF-1004

  • Lacrimal punctum plug
VeraPlug Flow Nonsterile Bulk - Medium
KRISHNA IMPORTS INC
BVF-1002
In Commercial Distribution

  • 00810799030221 ()
  • 00810799030184 ()
BVF-1002

  • Lacrimal punctum plug
VeraPlug FlexFit Nonsterile Bulk - Large
KRISHNA IMPORTS INC
BFF-5003
In Commercial Distribution

  • 00810799030122 ()
  • 00810799030085 ()
BFF-5003

  • Lacrimal punctum plug
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