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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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Darby Dental Supply, LLC - 00889813004685

STEEL BURS RA 5 DARBY
DARBY DENTAL SUPPLY, LLC
RA 5
In Commercial Distribution

  • 00889813004685 ()
  • 00889813004678 ()
9520460

  • Steel dental bur, reusable

Darby Dental Supply, LLC - 00889813004944

CARBIDE BURS FG 5 DARBY
DARBY DENTAL SUPPLY, LLC
FG 5
In Commercial Distribution

  • 00889813004944 ()
  • 00889813004937 ()
9525120

  • Carbide dental bur, reusable

Darby Dental Supply, LLC - 00889813007006

CARBIDE BURS RA 5 DARBY
DARBY DENTAL SUPPLY, LLC
RA 5
In Commercial Distribution

  • 00889813007006 ()
  • 00889813006993 ()
9525580

  • Carbide dental bur, reusable

AMPLIM - 00810477026416

AMPLIM Ovulation Test Kit (20 Ovulation Test+ 5 Early Pregnancy Tests)
AMPLIM, LLC
A8177W-20+5
In Commercial Distribution

  • 00810477026416 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

AMPLIM - 00810477026287

AMPLIM Ovulation Test Kit (20 Ovulation Test+ 5 Early Pregnancy Tests)
AMPLIM, LLC
A8177-20+5
In Commercial Distribution

  • 00810477026287 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

ProSpore2 - M985PS235501

Self-contained biological indicator for use in steam sterilization. Log 5. 50 count package.
MESA LABORATORIES, INC.
Log 5
Not in Commercial Distribution

  • M985PS235501 ()
  • M985PS235500 ()
PS2-3-5-50

  • Biological sterilization indicator

Smart-Read EZTest Steam - M985SEZS5251

Self-contained biological indicator for use in steam sterilization processes. Log 5 population. 25 count box.
MESA LABORATORIES, INC.
Log 5
In Commercial Distribution

  • M985SEZS5251 ()
  • M985SEZS5250 ()
SEZS/525

  • Biological sterilization indicator

ProSpore2 - M985PS2351

Biological Indicator intended for steam sterilization (121C). Contains spores of Geobacillus stearothermophilus. 50 units / box
MESA LABORATORIES, INC.
Log 5
Not in Commercial Distribution

  • M985PS2351 ()
  • M985PS23550 ()
PS2-3-5-50

  • Biological sterilization indicator

FifthPulse - 00810084936887

Instant Cold Pack
Jeg & Sons Inc.
5 Pack
In Commercial Distribution

  • 00810084938355 ()
  • 00810084936887 ()
FMN100525

  • Hot/cold therapy pack, single-use

Surround - 00812747010170

Surround version 5.x.x
HAEMONETICS CORPORATION
5.x.x
In Commercial Distribution

  • 00812747010170 ()


  • Blood bank information system application software
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