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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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Acuity - 00850203008026

Rigid-gas-permeable contact lens - daily wear enflufocon B
ACUITY POLYMERS, INC.
58
In Commercial Distribution

  • 00850203008026 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear

ZQuiet S.A. - 00858522003241

ZQuiet S.A. Dental Size B Single Unit
SLEEPING WELL, LLC
ZQSA-XDB
In Commercial Distribution

  • 00858522003241 ()
  • 10858522003248 ()


  • Mandible-repositioning sleep-disordered breathing orthosis

Medline Industries, Inc. - 10195327136918

TOTAL KNEE PACK PART A AND B
MEDLINE INDUSTRIES, INC.
DYNJ65796D
In Commercial Distribution

  • 10195327136918 ()
DYNJ65796D

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

Medline Industries, Inc. - 10889942553655

SCISSOR OP 5.75 S/B STR HGS
MEDLINE INDUSTRIES, INC.
DYNJZ58742
In Commercial Distribution

  • 10889942553655 ()
DYNJZ58742

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

Medline Industries, Inc. - 10889942594290

BONE RECOVERY PACK A,B,C II
MEDLINE INDUSTRIES, INC.
DYNJ55960
In Commercial Distribution

  • 10889942594290 ()
DYNJ55960

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

Medline Industries, Inc. - 10889942635221

OPEN HEART A,B, TRAY (ABTXC)61
MEDLINE INDUSTRIES, INC.
DYNJ56206
In Commercial Distribution

  • 10889942635221 ()
DYNJ56206

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

Spex Limited - 09420051709935

Vigour/Spex B/rest lumbar & lateral kit
SPEX LIMITED
1209-2713-300
In Commercial Distribution

  • 09420051709935 ()


  • Wheelchair back rest

COAGULATION ELECTRODE - 04953170139635

CD-6C-1.B MAIN BODY ONLY COAG ELECTRODE
OLYMPUS MEDICAL SYSTEMS CORP.
CD-6C-1
Not in Commercial Distribution

  • 14953170139632 ()
  • 04953170139635 ()


  • Electrocautery system electrode

LIGATING DEVICE - 04953170044922

HX-20U-1.B DETACH LOOP 2.8MM CHAN 230CM
OLYMPUS MEDICAL SYSTEMS CORP.
HX-20U-1
Not in Commercial Distribution

  • 14953170044929 ()
  • 04953170044922 ()


  • Polypectomy endoscopic ligator, reusable

PAPILLOTOMY KNIFE - 04953170038709

KD-27Q-1.B PUSH TYPE SPHINCTEROTOME W/ST
OLYMPUS MEDICAL SYSTEMS CORP.
KD-27Q-1
Not in Commercial Distribution

  • 14953170038706 ()
  • 04953170038709 ()
  • 84953170038705 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
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