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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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Standard BodySet® with Needleless Connectors - B101A120125XSE0

128 in. (320 cm) For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-125XSE
Not in Commercial Distribution

  • B101A120125XSE1 ()
  • B101A120125XSE0 ()


  • Electric infusion pump administration set, single-use

Standard BodySet® with Needleless Connectors - B101A120125XS0

115 in. (290 cm) For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-125XS
Not in Commercial Distribution

  • B101A120125XS1 ()
  • B101A120125XS0 ()


  • Electric infusion pump administration set, single-use

BodyGuard® Microset with Needleless Y-Site - B101A120003XYVA0

150 in. (380 cm) For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-003XYVA
Not in Commercial Distribution

  • B101A120003XYVA0 ()
  • B101A120003XYVA1 ()


  • Electric infusion pump administration set, single-use

BodyGuard® Microset with Needleless Adaptor - B101A120003XSNY0

83 in. (210 cm) For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-003XSNY
Not in Commercial Distribution

  • B101A120003XSNY1 ()
  • B101A120003XSNY0 ()


  • Electric infusion pump administration set, single-use

BodyGuard® set with Female Luer - B101A120003XSN0

83 in. (210 cm) For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-003XSN
Not in Commercial Distribution

  • B101A120003XSN0 ()
  • B101A120003XSN1 ()


  • 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

TheraStrand® with I-Seed - 00813787020310

TheraStrand® TSL in TPSII Ind.– 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX7215iN
In Commercial Distribution

  • 00813787020310 ()


  • Manual brachytherapy source, permanent implant

TheraStrand® with I-Seed - 00813787020303

TheraStrand® TSL in TPSII Single – 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX7215i
In Commercial Distribution

  • 00813787020303 ()


  • Manual brachytherapy source, permanent implant

I-Seed Agx100 - 00813787020167

C20 in TPSII x = 10, 15 or 20 seeds per mag - STERILE
THERAGENICS CORPORATION
XX65xi
In Commercial Distribution

  • 00813787020167 ()


  • Manual brachytherapy source, permanent implant

TheraStrand® with TheraSeed® - 00813787020921

Loose TheraStrand with 1-6 seeds, standard spacing, in TPSII Ind. for CN
THERAGENICS CORPORATION
XX72xLN
Not in Commercial Distribution

  • 00813787020921 ()


  • Manual brachytherapy source, permanent implant
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