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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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PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL11-J10 (Made in Malaysia)
HOYA CORPORATION
VNL11-J10
Not in Commercial Distribution

  • 04961333251148 ()
  • 04961333251155 ()


  • Flexible video otorhinolaryngoscope, reusable
PENTAX VIDEO UPPER G.I.SCOPE EG29-i10 (Made in Malaysia)
HOYA CORPORATION
EG29-i10
Not in Commercial Distribution

  • 04961333248292 ()
  • 04961333248315 ()


  • Flexible video gastroscope, reusable
PENTAX VIDEO COLONOSCOPE EC38-i10 SERIES (Made in Malaysia)
HOYA CORPORATION
EC38-i10L
Not in Commercial Distribution

  • 04961333248186 ()
  • 04961333248209 ()


  • Flexible video colonoscope, reusable
PENTAX VIDEO COLONOSCOPE EC-3890i SERIES (Made in Malaysia)
HOYA CORPORATION
EC-3890Li
Not in Commercial Distribution

  • 04961333248124 ()
  • 04961333248148 ()


  • Flexible video colonoscope, reusable
NUT 99910100 LP FLANGE NUT 1/4 IN
MEDTRONIC SOFAMOR DANEK, INC.
99910100
In Commercial Distribution

  • 00613994582041 ()


  • Spinal bone screw, non-bioabsorbable
D.Zap Single Insertion-Used in KTF1001, not sold individually
FHC, INC.
66-IT-40L-00851
In Commercial Distribution

  • 00873263008515 ()
66-IT-40L

  • Intracerebral cannula, nonimplantable, single-use
A-dec NLX,Tubing,Nano Motor,68 IN,Integrated
A-DEC, INC.
54.0708.00
In Commercial Distribution

  • 10194665006181 ()
54.0708.00

  • Dental surgical power tool motor, electric
CUP CURETTE X1098-050 OVL 11MM LEN 14 IN
MEDTRONIC SOFAMOR DANEK, INC.
X1098-050
In Commercial Distribution

  • 00673978152042 ()


  • Bone curette, reusable
CUP CURETTE X1098-049 OVAL 7MM LEN 14 IN
MEDTRONIC SOFAMOR DANEK, INC.
X1098-049
In Commercial Distribution

  • 00673978152035 ()


  • Bone curette, reusable
CUP CURETTE X1098-048 OVAL 5MM LEN 14 IN
MEDTRONIC SOFAMOR DANEK, INC.
X1098-048
In Commercial Distribution

  • 00673978152028 ()


  • Bone curette, reusable
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