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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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TheraSeed - 00813787020716

IsoLoader magazines in TPSII Ind. - 20 seeds per mag- STERILE
THERAGENICS CORPORATION
XX5056N
In Commercial Distribution

  • 00813787020716 ()


  • Manual brachytherapy source, permanent implant

TheraSeed - 00813787020709

C20 IsoLoader magazines in TPSII – 20 seeds per mag- STERILE
THERAGENICS CORPORATION
XX5057
In Commercial Distribution

  • 00813787020709 ()


  • Manual brachytherapy source, permanent implant

TheraSeed - 00813787020662

In-STANT magazines in TPSII Ind. - 20 seeds per mag - STERILE
THERAGENICS CORPORATION
XX1520N
In Commercial Distribution

  • 00813787020662 ()


  • Manual brachytherapy source, permanent implant

AnchorSeed with TheraSeed® - 00813787021126

AnchorSeed in TPSII Ind.– 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX77215N
In Commercial Distribution

  • 00813787021126 ()


  • Manual brachytherapy source, permanent implant

AnchorSeed with I-Seed - 00813787021119

AnchorSeed in TPSII Ind.– 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX77215iN
In Commercial Distribution

  • 00813787021119 ()


  • Manual brachytherapy source, permanent implant

SmarTemp® - 00810000525294

Dual Cure A2 (Light Shade) SmarTemp® in 50ml. Cartridge
PARKELL, INC.
S338
In Commercial Distribution

  • 00810000525294 ()
S338

  • Temporary dental crown/bridge resin

Human Albumin - 20888937818738

Human Albumin. 100 mg/ml in Normal Saline. 12x5 ml
Origio A/S
ART-3001
In Commercial Distribution

  • 20888937818738 ()
  • 00888937818703 ()


  • IVF medium

MiniMe Pediatric Mask with Headgear, Size Large - 00814747024638

Pediatric nasal vented mask for use in positive pressure ventilation.
SLEEPNET, CORP.
60215
In Commercial Distribution



  • CPAP/BPAP nasal mask, reusable

MiniMe Pediatric Mask with Headgear, Size Medium - 00814747024621

Pediatric nasal vented mask for use in positive pressure ventilation.
SLEEPNET, CORP.
60214
In Commercial Distribution



  • CPAP/BPAP nasal mask, reusable

MiniMe Pediatric Mask with Headgear, Size Small - 00814747024614

Pediatric nasal vented mask for use in positive pressure ventilation.
SLEEPNET, CORP.
60213
In Commercial Distribution



  • CPAP/BPAP nasal mask, reusable
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