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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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Regard™ - 10194717113911

TOT HIP ARTHRO A&B
ROI CPS, LLC
OR00032W
Not in Commercial Distribution

  • 20194717113918 ()
  • 10194717113911 ()


  • Orthopaedic surgical procedure kit, non-medicated, single-use

Regard™ - 10194717117100

HIP AUXILIARY A&B PK
ROI CPS, LLC
OR00022S
Not in Commercial Distribution

  • 20194717117107 ()
  • 10194717117100 ()


  • Orthopaedic surgical procedure kit, non-medicated, single-use

Regard™ - 10194717117018

TOT HIP ARTHRO A&B
ROI CPS, LLC
OR00032X
Not in Commercial Distribution

  • 20194717117015 ()
  • 10194717117018 ()


  • Orthopaedic surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10889942600090

TOTAL HIP A&B PACK
MEDLINE INDUSTRIES, INC.
DYNJ56026
In Commercial Distribution

  • 10889942600090 ()
DYNJ56026

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327018306

LUMBAR B MODULE ANAGNOST CDS
MEDLINE INDUSTRIES, INC.
DYNJ901885C
In Commercial Distribution

  • 10195327018306 ()
DYNJ901885C

  • General surgical procedure kit, medicated

Medline Industries, Inc. - 10195327039448

TOTAL HIP A&B PACK
MEDLINE INDUSTRIES, INC.
DYNJ56026F
In Commercial Distribution

  • 10195327039448 ()
DYNJ56026F

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327026004

TOTAL KNEE BASIN B PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0867555K
In Commercial Distribution

  • 10195327026004 ()
DYNJ0867555K

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327353445

TOTAL JOINT A&B PACK
MEDLINE INDUSTRIES, INC.
DYNJ82777C
In Commercial Distribution

  • 40195327353446 ()
  • 10195327353445 ()
DYNJ82777C

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327118662

TOTAL KNEE PACK A&B
MEDLINE INDUSTRIES, INC.
DYNJ64005D
In Commercial Distribution

  • 10195327118662 ()
DYNJ64005D

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327118631

INSTRUMENTAL SPINE PACK A&B
MEDLINE INDUSTRIES, INC.
DYNJ64013C
In Commercial Distribution

  • 10195327118631 ()
DYNJ64013C

  • General surgical procedure kit, non-medicated, single-use
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