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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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Child Curved Sternal Retractor with Blades Only - B040CSRAR0

Child Curved Sternal Latch Retractor with atrial and aortic rakes: Suitable for patients weighing from 15 to 45 kg
GENESEE BIOMEDICAL, INC.
CSR-AR
In Commercial Distribution

  • B040CSRAR0 ()
CSR-AR

  • Sternum spreader

Child Curved Sternal Retractor with Blades Only - B040CSR1

Child Curved Sternal Latch Retractor with 2 sets of Blades: Suitable for patients weighing from 15 to 45kg
GENESEE BIOMEDICAL, INC.
CSR-1
In Commercial Distribution

  • B040CSR1 ()
CSR-1

  • Sternum spreader

CMExpress® Microbore Set with Needleless Y-Site - B101A120161CYF0

105 in. (267 cm) CMExpress® Microbore Set w/ Needleless Y-Site For Use with the CMExpress® Infusion Pump
CME AMERICA LLC
A120-161CYF
Not in Commercial Distribution

  • B101A120161CYF1 ()
  • B101A120161CYF0 ()


  • Electric infusion pump administration set, single-use

BodyGuard® Microset with compression fit adapter - B101A120160GCFA0

80 in. (200 cm) BodyGuard® Fluid Transfer MicroSet, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-160GCFA
Not in Commercial Distribution

  • B101A120160GCFA0 ()
  • B101A120160GCFA1 ()


  • Electric infusion pump administration set, single-use

CMExpress® Set with Needleless Y Sites - B101A120160C2YRV0

95 in. (240 cm) For Use with the CMExpress® Infusion Pump
CME AMERICA LLC
A120-160C2YRV
Not in Commercial Distribution

  • B101A120160C2YRV1 ()
  • B101A120160C2YRV0 ()


  • Electric infusion pump administration set, single-use

BodyGuard® Set with Needleless Y Sites - B101A120003XS2YV0

115 in. (290 cm) For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-003XS2YV
Not in Commercial Distribution

  • B101A120003XS2YV0 ()
  • B101A120003XS2YV1 ()


  • Electric infusion pump administration set, single-use

BodyGuard® Microset with Male Luer Connectors - B101A100163XEBF0

130 in. (330 cm) - yellow stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A100-163XEBF
Not in Commercial Distribution

  • B101A100163XEBF0 ()
  • B101A100163XEBF1 ()


  • Electric infusion pump administration set, single-use

ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY - B278AMMS070MF0

ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY ANTIBACTERIAL COATED MALE-FEMALE MIDSECTION SIZE 70MM
ONKOS SURGICAL, INC.
AM-MS-070MF
In Commercial Distribution

  • B278AMMS070MF0 ()

  • Length: 70 Millimeter


  • Body femoral/tibial extension stem, coated

ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY - B278AMMS060MF0

ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY ANTIBACTERIAL COATED MALE-FEMALE MIDSECTION SIZE 60MM
ONKOS SURGICAL, INC.
AM-MS-060MF
In Commercial Distribution

  • B278AMMS060MF0 ()

  • Length: 60 Millimeter


  • Body femoral/tibial extension stem, coated

ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY - B278AMMS050MF0

ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY ANTIBACTERIAL COATED MALE-FEMALE MIDSECTION SIZE 50MM
ONKOS SURGICAL, INC.
AM-MS-050MF
In Commercial Distribution

  • B278AMMS050MF0 ()

  • Length: 50 Millimeter


  • Body femoral/tibial extension stem, coated
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