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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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Surgical Gown, AAMI LV3, Reinforced L
Calico Medical Group LLC
SG010
In Commercial Distribution

  • 10850044458889 ()
  • 00850044458882 ()
SG010

  • Surgical gown, single-use
Surgical Gown, AAMI LV2, Non-Reinforced, XL
Calico Medical Group LLC
SG009
In Commercial Distribution

  • 10850044458872 ()
  • 00850044458875 ()
SG009

  • Surgical gown, single-use
Surgical Gown, AAMI LV2, Non-Reinforced, L
Calico Medical Group LLC
SG008
In Commercial Distribution

  • 10850044458865 ()
  • 00850044458868 ()
SG008

  • Surgical gown, single-use
Ultra Reinforced Surgical Gown with Poly Reinforcement, Size XX-LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case
Hilo Enterprises LLC
S4005
Not in Commercial Distribution

  • 00850038608095 ()


  • Surgical gown, single-use
Ultra Reinforced Surgical Gown with Poly Reinforcement, Size X-LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case
Hilo Enterprises LLC
S4004
Not in Commercial Distribution

  • 00850038608088 ()


  • Surgical gown, single-use
Ultra Reinforced Surgical Gown with Poly Reinforcement, Size LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case
Hilo Enterprises LLC
S4003
Not in Commercial Distribution

  • 00850038608071 ()


  • Surgical gown, single-use
Ultra Reinforced Surgical Gown with Poly Reinforcement, Size MEDIUM, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case
Hilo Enterprises LLC
S4002
Not in Commercial Distribution

  • 00850038608064 ()


  • Surgical gown, single-use
Ultra Reinforced Surgical Gown with Poly Reinforcement, Size SMALL, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case
Hilo Enterprises LLC
S4001
Not in Commercial Distribution

  • 00850038608057 ()


  • Surgical gown, single-use
Standard Surgical gown, Size XX-LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case
Hilo Enterprises LLC
S3005
Not in Commercial Distribution

  • 00850038608040 ()


  • Surgical gown, single-use
Standard Surgical gown, Size X-LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case
Hilo Enterprises LLC
S3004
Not in Commercial Distribution

  • 00850038608033 ()


  • Surgical gown, single-use
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