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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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Narrow Introducer for Extended Heights H is greater than or equal to 10
Spineup, Inc.
RO0004NIEH
In Commercial Distribution

  • B806RO0004NIEH0 ()
RO0004NIEH

  • Orthopaedic inorganic implant inserter/extractor, reusable
Furcation Curette Set is composed of 2 Curettes buccal-lingual 2 Curettes mesial-distal and
A. Schweickhardt GmbH & Co. KG
3308-100
In Commercial Distribution

  • E89633081000 ()
3308-100

  • Periodontal curette
Insert W1 is used to perforate the bone, creating the initial pilot osteotomy.
MECTRON SPA
W1 -US-
In Commercial Distribution

  • E322045700011010 ()
04570001-101

  • Dental ultrasonic surgical system handpiece tip
The device is intended to be used for sternal retraction on adult patients.
Coroneo Inc
1010807
In Commercial Distribution

  • 10817121000324 ()

  • Large
1010807

  • Rib spreader, reusable
The device is intended to be used for sternal retraction on adult patients.
Coroneo Inc
1010900
In Commercial Distribution

  • 10817121000294 ()

  • Small
1010900

  • Rib spreader, reusable
This device is used to drill a hole when inserting Fixone Interference screw.
AJU PHARM. CO., LTD.
Fixone.I.I-Driver
In Commercial Distribution

  • 08800039100717 ()


  • Fluted surgical drill bit, single-use
This device is used to drill a hole when inserting Fixone Interference screw.
AJU PHARM. CO., LTD.
Fixone.I.I-T8090
In Commercial Distribution

  • 08800039100700 ()


  • Bone tap, reusable
This instrument is intended to make a drilling path for orthopedic bone screws.
AJU PHARM. CO., LTD.
Fixone.I.B-A/T550a
In Commercial Distribution

  • 08800039100649 ()


  • Bone tap, reusable
This instrument is intended to make a drilling path for orthopedic bone screws.
AJU PHARM. CO., LTD.
Fixone.I.B-A/T450a
In Commercial Distribution

  • 08800039100632 ()


  • Bone tap, reusable
This instrument is intended to make a drilling path for orthopedic bone screws.
AJU PHARM. CO., LTD.
Fixone.I.B-Awl550ak
In Commercial Distribution

  • 08800039100625 ()


  • Bone awl, reusable
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