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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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4900 7L SYRINGE - 00817136021287

4900 7L SYR 1.375 ID O-RNG"
HANS RUDOLPH, INC.
4900
In Commercial Distribution

  • 00817136021287 ()
113622

  • Spirometer/pulmonary function analyser syringe

Fungal Serology - 10634853000121

Histoplasma capsulatum Antiserum, 1mL ID/EXO
MICROBIOLOGICS INC.
200260
Not in Commercial Distribution

  • 10634853000121 ()
200260

  • Histoplasma capsulatum exoantigen IVD, control

Fungal Serology - 10634853000084

Coccidioides immitis Antiserum (HS), ID/EXO
MICROBIOLOGICS INC.
200270
Not in Commercial Distribution

  • 10634853000084 ()
200270

  • Coccidioides immitis exoantigen IVD, control

Fungal Serology - 10634853000039

Blastomyces dermatitidis Antiserum, 1mL ID/EXO
MICROBIOLOGICS INC.
200265
Not in Commercial Distribution

  • 10634853000039 ()
200265

  • Blastomyces dermatitidis exoantigen IVD, control

IMMY - 00816387020469

4-Series Cleargel ID Plates, Small Well
Immuno-Mycologics, Inc.
ID1019
In Commercial Distribution

  • 00816387020469 ()


  • Agar medium preparation kit IVD

SpiritMB - 00889989007473

ID P - Twin - Upper-Universal Bicuspid-Hook - Orange
ORMCO CORPORATION
495-1514
Not in Commercial Distribution

  • 00889989007473 ()
  • 10889989007470 ()

  • Slot: .022, Torque: -7


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007466

ID U - Twin - Lower-Left Cuspid-Hook - Purple
ORMCO CORPORATION
495-1411
Not in Commercial Distribution

  • 00889989007466 ()
  • 10889989007463 ()

  • Slot: .022, Torque: -7


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007459

ID U - Twin - Lower-Right Cuspid-Hook - Purple
ORMCO CORPORATION
495-1410
Not in Commercial Distribution

  • 00889989007459 ()
  • 10889989007456 ()

  • Slot: .022, Torque: -7


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007442

ID K - Twin - Upper-Left Cuspid-Hook - Green
ORMCO CORPORATION
495-1301
Not in Commercial Distribution

  • 00889989007442 ()
  • 10889989007449 ()

  • Slot: .022, Torque: 0


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007435

ID K - Twin - Upper-Right Cuspid-Hook - Green
ORMCO CORPORATION
495-1300
Not in Commercial Distribution

  • 00889989007435 ()
  • 10889989007432 ()

  • Slot: .022, Torque: 0


  • Orthodontic bracket, plastic, single-use
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