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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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16x16 Premium Thermal - NiTi - Euro - U
Acme Monaco Corporation
AMC1616UMAREU
In Commercial Distribution

  • D972AMC1616UMAREU2 ()
  • AMC1616UMAREU0 ()


  • Orthodontic archwire
16x16 Premium Thermal - NiTi - Nat - U
Acme Monaco Corporation
AMC1616UMAR
In Commercial Distribution

  • D972AMC1616UMAR2 ()
  • AMC1616UMAR0 ()


  • Orthodontic archwire
.014 Premium Thermal NiTi - Euro - U
Acme Monaco Corporation
AMC14UMAREU
In Commercial Distribution

  • D972AMC14UMAREU2 ()
  • AMC14UMAREU0 ()


  • Orthodontic archwire
.014 Premium Thermal NiTi - Nat - U
Acme Monaco Corporation
AMC14UMAR
In Commercial Distribution

  • D972AMC14UMAR2 ()
  • AMC14UMAR0 ()


  • Orthodontic archwire
14x25 Premium Thermal NiTi - Nat - U
Acme Monaco Corporation
AMC1425UMAR
In Commercial Distribution

  • D972AMC1425UMAR2 ()
  • AMC1425UMAR0 ()


  • Orthodontic archwire
.012 Premium Thermal NiTi - Euro - U
Acme Monaco Corporation
AMC12UMAREU
In Commercial Distribution

  • D972AMC12UMAREU2 ()
  • AMC12UMAREU0 ()


  • Orthodontic archwire
.012 Premium Thermal NiTi - Nat - U
Acme Monaco Corporation
AMC12UMAR
In Commercial Distribution

  • D972AMC12UMAR2 ()
  • AMC12UMAR0 ()


  • Orthodontic archwire
CHP BASIC G U PACK BCS
MEDLINE INDUSTRIES, INC.
DYNJ02671D
In Commercial Distribution

  • 10889942343041 ()
DYNJ02671D

  • General surgical procedure kit, non-medicated, reusable
COMPOSITE NB TESCERA - U / BEAM GUIDE
Power Dental U.S.A. Inc.
5120
In Commercial Distribution

  • D9435120 ()
5120

  • Margin finishing dental file/rasp, reusable
  • Dental amalgam carrier
  • Dental spatula, reusable
T U R ADD ON PACK
MEDLINE INDUSTRIES, INC.
DYNJ45492B
In Commercial Distribution

  • 10889942624225 ()
  • 40889942624226 ()
DYNJ45492B

  • General surgical procedure kit, non-medicated, single-use
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