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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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ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY - B278AMMS040MF0

ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY ANTIBACTERIAL COATED MALE-FEMALE MIDSECTION SIZE 40MM
ONKOS SURGICAL, INC.
AM-MS-040MF
In Commercial Distribution

  • B278AMMS040MF0 ()

  • Length: 40 Millimeter


  • Body femoral/tibial extension stem, coated

Tamper Evident Cap with Male Luer Lock - B2125791R1

Sterile Red Tamper Evident Caps with Male Luer Lock Fitting. Provides evidence of access and maintains sterility. 1 Cap per sterile blister, 100 caps per shipper box
INTERNATIONAL MEDICAL INDUSTRIES INC.
57-91 R
In Commercial Distribution

  • B2125791R2 ()
  • B2125791R1 ()
57-91 R

  • Basic intravenous administration set, noninvasive

Tamper Evident Cap for use with ENFit - B21257220100RFID1

Tamper Evident Cap for Use With ENFit® Syringes (ETEC)
INTERNATIONAL MEDICAL INDUSTRIES INC.
57-220-100 RFID
In Commercial Distribution

  • B21257220100RFID0 ()
  • B21257220100RFID1 ()
  • B21257220100RFID2 ()


  • ENFit-formatted protective cap

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

BRAEBON Ultima Snoring Sensor with Keyhole Connector - B14005430

For use during sleep disorder studies as a measure of snoring for recording onto a data acquisition system.
Braebon Medical Corporation
0543
In Commercial Distribution

  • B14005430 ()
0543

  • Freestanding microphone

FlexGuard Laser Fiber with Extended Length Sheath - B14527750300U1SH0

300 micrometer FlexGuard fiber with extended length sheath
OPTICAL INTEGRITY INC
27750300U1SH
Not in Commercial Distribution

  • B14527750300U13SH1 ()
  • B14527750300U1SH0 ()

  • fiber core diameter
  • Outer Diameter: 300 Micrometer


  • General/multiple surgical laser system beam guide, reusable
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