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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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CONDUIT Straight TLIF / PLIF Core Instrument Case
Medos International Sàrl
PEC00100C
In Commercial Distribution

  • 10705034565958 ()
PEC00100C

  • Surgical instrument/implant rack
1870+ HEALTH CARE PART RESP. 120/CASE
3M Company
1870+
In Commercial Distribution

  • 50051131499961 ()
  • 00051131499966 ()
  • 00051131272330 ()
1870+

  • Surgical/medical respirator, non-antimicrobial, single-use
EXPEDIUM OSTEOTOMY SET HINGED SPOON RETRACTOR CASE
Medos International Sàrl
279755910
In Commercial Distribution

  • 10705034472751 ()
279755910

  • Instrument tray, reusable
OTC hearing aids, with battery display case
Voxx Accessories Corp.
RSH20GYW
In Commercial Distribution

  • 00044476153181 ()


  • Air-conduction hearing aid, in-the-ear
COUGAR LS LATERAL ANGLED INSTRUMENTS CASE LID
DEPUY SPINE, LLC
287101056
In Commercial Distribution

  • 10705034359816 ()
287101056

  • Instrument tray, reusable
CASE FOR 23 AUSTIN INSTRUMENTS STAINLESS STEEL
Gyrus ACMI, LLC
130052
In Commercial Distribution

  • 00821925011625 ()


  • Ear knife
OTC hearing aids, with battery display case
Voxx Accessories Corp.
RSH20WH
In Commercial Distribution

  • 00044476153198 ()


  • Air-conduction hearing aid, in-the-ear
OTC hearing aids, with battery display case
Voxx Accessories Corp.
RSH20BGW
In Commercial Distribution

  • 00044476153174 ()


  • Air-conduction hearing aid, in-the-ear
CASE AMALGAM GOLD KIT 2ND YR 1P
Peter Brasseler Holdings, LLC
5012085U0
In Commercial Distribution

  • 00887919558897 ()


  • Diamond dental bur, single-use
Royal Oak IBFD Instrument Set Case 2
Royal Oak Medical Devices LLC
4502081
In Commercial Distribution

  • 00812352021295 ()


  • External spinal fixation system
Royal Oak IBFD Instrument Set Case 1
Royal Oak Medical Devices LLC
4501081
In Commercial Distribution

  • 00812352021288 ()


  • External spinal fixation system
NovoHip DAA Femoral Prep Case - Level 3
Novosource, LLC
1611-100-001
In Commercial Distribution

  • 00811382038853 ()
1611-100-001

  • Joint prosthesis implantation kit, reusable
Fall Guardian Motion Sensor and Pager case
Smart Caregiver Corporation
FGPM/CS
In Commercial Distribution

  • 00812293015452 ()


  • Nurse call system
FallGuard Economy Monitor with chair pad case
Smart Caregiver Corporation
FG2C90-SYS/CS
In Commercial Distribution

  • 00812293015315 ()


  • Bed/chair occupant movement pressure/vibration sensor
Vital™ MIS Instrument Case 2 Base
ZIMMER BIOMET INC
800M1300-01
In Commercial Distribution

  • 00887868360480 ()


  • Instrument tray, reusable
Vital™ MIS Instrument Case 1 Base
ZIMMER BIOMET INC
800M1300-01
In Commercial Distribution

  • 00887868360473 ()


  • Instrument tray, reusable
Vital™ MIS Instrument Case 1 Base
ZIMMER BIOMET INC
800M1200-01
In Commercial Distribution

  • 00887868360466 ()


  • Instrument tray, reusable
5RDS w/4M+ BZO CARD 50/case
AMERICAN BIO MEDICA CORPORATION
10-5MZS-030
In Commercial Distribution

  • 10694644300335 ()
  • 10694644350330 ()
10-5MZS-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
Medfix Vision Universal 3 Level Small Case
NEXUS SPINE, L.L.C.
821083.35
Not in Commercial Distribution

  • B678821083350 ()


  • Spinal fixation plate, non-bioabsorbable
Medfix Vision Universal 1 Level Large Case
NEXUS SPINE, L.L.C.
821082.03
Not in Commercial Distribution

  • B678821082030 ()


  • Spinal fixation plate, non-bioabsorbable
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