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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One PureSleep PRO Anti-Snoring Device Kit US
SLEEP SCIENCE PARTNERS, INC.
PSKITPROA
In Commercial Distribution

  • 00851727004037 ()
PSKITPROA

  • Mandible-repositioning sleep-disordered breathing orthosis
Clik-FIX All 'n One Peripheral IV Securement
STARBOARD MEDICAL, INC.
PCS-1011
In Commercial Distribution

  • 10850933007013 ()
  • 00850933007016 ()
  • 20850933007010 ()
PCS-1011

  • Wearable percutaneous catheter/tube holder
All 'n One PICC/Central Catheter Securement
STARBOARD MEDICAL, INC.
WCS-1051
In Commercial Distribution

  • 10850933007143 ()
  • 00850933007146 ()
WCS-1051

  • Wearable percutaneous catheter/tube holder
One Step Home Use Pregnancy Test Strip
Mfb Fertility, Inc.
Check
In Commercial Distribution

  • 00850035206003 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Matrix Max Raw AFO (One Size Right)
TRULIFE LIMITED
FH225-R
In Commercial Distribution

  • 00645517800240 ()


  • Ankle/foot orthosis
Matrix Max Raw AFO (One Size Left)
TRULIFE LIMITED
FH225-L
In Commercial Distribution

  • 00645517800233 ()


  • Ankle/foot orthosis
WAIST TRIMMER, BLACK, ONE SIZE FITS MOST
DJO, LLC
DP171SR01-BLK
In Commercial Distribution

  • 00190446241324 ()


  • Compression/pressure sock/stocking, reusable
Tibial Offset Blades (One Pair) with Screw
INNOMED, INC.
3630-02
In Commercial Distribution

  • 00840277105738 ()
3630-02

  • Orthopaedic inorganic implant inserter/extractor, reusable
Tibial Standard Blades (One Pair) with Screws
INNOMED, INC.
3630-01
In Commercial Distribution

  • 00840277105721 ()
3630-01

  • Orthopaedic inorganic implant inserter/extractor, reusable
CAP REMOVAL PLIER with one Blade mounted
A. Schweickhardt GmbH & Co. KG
5259
In Commercial Distribution

  • E89652590 ()
5259

  • Wire cutter
CAP REMOVAL PLIER with one Blade mounted
A. Schweickhardt GmbH & Co. KG
5258-2
In Commercial Distribution

  • E896525820 ()
5258-2

  • Wire cutter
UNLOADER ONE® X Right Lateral SM
DJO, LLC
88-045000528712
In Commercial Distribution

  • 00190446700258 ()


  • Knee support orthosis
UNLOADER ONE® X Right Medial MD
DJO, LLC
88-045000518713
In Commercial Distribution

  • 00190446699262 ()


  • Knee support orthosis
NIEVERT NH 5" ONE OFFSET HNDL CARB
ORTHO-MED, INC.
OM 41-0108
In Commercial Distribution

  • B8034101080 ()


  • Suturing needle holder, reusable
LDR One Step Pregnancy Test 2 tests
Cardinal Health 110, Inc.
5741889
In Commercial Distribution

  • 50096295141547 ()
  • 00096295141542 ()
  • 10096295141549 ()
5741889

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, rapid agglutination, clinical
LDR One Step Pregnancy Test 2 ea
Cardinal Health 110, Inc.
5741863
In Commercial Distribution

  • 50096295141523 ()
  • 00096295141528 ()
  • 10096295141525 ()
5741863

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, rapid agglutination, clinical
LDR One Step Pregnancy Test 1 ea
Cardinal Health 110, Inc.
5741855
In Commercial Distribution

  • 50096295141516 ()
  • 00096295141511 ()
5741855

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, rapid agglutination, clinical
Good Neighbor Pharmacy One Step Pregnancy Test
Amerisourcebergen Drug Corporation
FPPL
Not in Commercial Distribution

  • 00087701552625 ()
  • 10087701552622 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
CVS Biodegradable Glove - One size fit all.
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
460866
In Commercial Distribution

  • 10842942016759 ()
  • 00050428447772 ()
  • 00842942016752 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
ANTERIOR TENSION BAND TEMPLATE ONE LEVEL 51MM
SYNTHES (U.S.A.) LP
03.601.118
In Commercial Distribution

  • H981036011180 ()
  • 10705034711959 ()
03601118

  • Spinal implant trial
ANTERIOR TENSION BAND TEMPLATE ONE LEVEL 49MM
SYNTHES (U.S.A.) LP
03.601.117
In Commercial Distribution

  • H981036011170 ()
  • 10705034711942 ()
03601117

  • Spinal implant trial
ANTERIOR TENSION BAND TEMPLATE ONE LEVEL 47MM
SYNTHES (U.S.A.) LP
03.601.116
In Commercial Distribution

  • H981036011160 ()
  • 10705034711935 ()
03601116

  • Spinal implant trial
ANTERIOR TENSION BAND TEMPLATE ONE LEVEL 45MM
SYNTHES (U.S.A.) LP
03.601.115
In Commercial Distribution

  • H981036011150 ()
  • 10705034711928 ()
03601115

  • Spinal implant trial
ANTERIOR TENSION BAND TEMPLATE ONE LEVEL 43MM
SYNTHES (U.S.A.) LP
03.601.114
In Commercial Distribution

  • H981036011140 ()
  • 10705034711911 ()
03601114

  • Spinal implant trial
ANTERIOR TENSION BAND TEMPLATE ONE LEVEL 41MM
SYNTHES (U.S.A.) LP
03.601.113
In Commercial Distribution

  • H981036011130 ()
  • 10705034711904 ()
03601113

  • Spinal implant trial
ANTERIOR TENSION BAND TEMPLATE ONE LEVEL 39MM
SYNTHES (U.S.A.) LP
03.601.112
In Commercial Distribution

  • H981036011120 ()
  • 10705034711898 ()
03601112

  • Spinal implant trial
ANTERIOR TENSION BAND TEMPLATE ONE LEVEL 37MM
SYNTHES (U.S.A.) LP
03.601.111
In Commercial Distribution

  • H981036011110 ()
  • 10705034711881 ()
03601111

  • Spinal implant trial
ANTERIOR TENSION BAND TEMPLATE ONE LEVEL 35MM
SYNTHES (U.S.A.) LP
03.601.110
In Commercial Distribution

  • H981036011100 ()
  • 10705034711874 ()
03601110

  • Spinal implant trial
2100C NO W/ONE PORT ADPT 2OD
HANS RUDOLPH, INC.
2100
Not in Commercial Distribution

  • 00817136024240 ()
CR1295

  • Pulmonary function valve
Eversense Sensor Kit contains one Eversense Sensor.
SENSEONICS, INCORPORATED
FG-4202-00-301
Not in Commercial Distribution

  • 00817491022523 ()
FG-4202-00-301

  • Implantable glucose monitoring system sensor
Eversense Sensor Kit contains one Eversense Sensor.
SENSEONICS, INCORPORATED
FG-4201-00-301
Not in Commercial Distribution

  • 00817491022356 ()
FG-4201-00-301

  • Implantable glucose monitoring system sensor
Eversense Sensor Kit contains one Eversense Sensor.
SENSEONICS, INCORPORATED
FG-4200-00-301
Not in Commercial Distribution

  • 00817491022349 ()
FG-4200-00-301

  • Implantable glucose monitoring system sensor
Eversense Sensor Kit contains one Eversense Sensor.
SENSEONICS, INCORPORATED
FG-4201-00-301
Not in Commercial Distribution

  • 00817491021427 ()
FG-4201-00-301

  • Implantable glucose monitoring system sensor
Eversense Sensor Kit contains one Eversense Sensor.
SENSEONICS, INCORPORATED
FG-4200-00-301
Not in Commercial Distribution

  • 00817491021410 ()
FG-4200-00-301

  • Implantable glucose monitoring system sensor
C-Pouch Drape, One Piece 267x152cm - 105"x60"
EXACT MEDICAL MANUFACTURING, INC.
E5929
Not in Commercial Distribution

  • 00816953024518 ()
  • 00816953024501 ()
  • 00816953024525 ()


  • Medical equipment/instrument drape, single-use
Scanning Body for Multi-Unit Abutment Implant One
Implant Logistics, Inc.
IT137-SCAN
In Commercial Distribution

  • D762IT137SCAN0 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
Crescent Frame w/Arm, One Piece, Mini
INTEGRA LIFESCIENCES CORPORATION
3570P
In Commercial Distribution

  • M2483570P1 ()
  • 10381780273813 ()
3570P

  • Surgical retraction system, reusable
DISPOSABLE SNARE WIRES, STRANDED WIRE, ONE DOZEN.
FTT MEDICAL, INC.
45-0020
In Commercial Distribution

  • B3964500200 ()


  • Rigid polypectomy snare, single-use
DISPOSABLE SNARE WIRES, SPRING WIRE, ONE DOZEN.
FTT MEDICAL, INC.
45-0016
In Commercial Distribution

  • B3964500160 ()


  • Rigid polypectomy snare, single-use
DISPOSABLE SNARE WIRES, SOFT WIRE, ONE DOZEN.
FTT MEDICAL, INC.
45-0018
In Commercial Distribution

  • B3964500180 ()


  • Rigid polypectomy snare, single-use
EXAFLEX® Catalyst (One pail 30 kg)
Gc America Inc.
138332
In Commercial Distribution

  • 10386040005982 ()
138332

  • Silicone dental impression material
MONARCH SPINE SYSTEM SPINE PLATE, ONE SLOT
DEPUY SPINE, LLC
177065010
Not in Commercial Distribution

  • 10705034057729 ()
177065010

  • Spinal fixation plate, non-bioabsorbable
MONARCH SPINE SYSTEM SPINE PLATE, ONE SLOT
DEPUY SPINE, LLC
177060010
Not in Commercial Distribution

  • 10705034057637 ()
177060010

  • Spinal fixation plate, non-bioabsorbable
OTC hearing aids, behind-the-ear design, one pair
Voxx Accessories Corp.
RSH052BK
In Commercial Distribution

  • 00044476153280 ()


  • Air-conduction hearing aid, behind-the-ear
OTC hearing aids, behind-the-ear design, one pair
Voxx Accessories Corp.
RSH052GY
In Commercial Distribution

  • 00044476153273 ()


  • Air-conduction hearing aid, behind-the-ear
OTC hearing aids, behind-the-ear design, one pair
Voxx Accessories Corp.
RSH052BG
In Commercial Distribution

  • 00044476153266 ()


  • Air-conduction hearing aid, behind-the-ear
CARE ONE COVERLETS CONTACT LENS CASE 1CT
APOTHECARY PRODUCTS, LLC
68737CO1
In Commercial Distribution

  • 20023185000386 ()
  • 00041520039293 ()
  • 10023185000730 ()


  • Contact lens case
Fusion Oasis, One Action Stent Introduction System
COOK IRELAND LTD
G31527
In Commercial Distribution

  • 00827002315273 ()
FS-OA-10

  • Endoscopic stent-placement system
Fusion Oasis, One Action Stent Introduction System
COOK IRELAND LTD
G31526
In Commercial Distribution

  • 00827002315266 ()
FS-OA-8.5

  • Endoscopic stent-placement system
MICRO CONICAL ABUTMENT ONE STEP HYBRID COPING
JJGC Indústria e Comércio de Materiais Dentários S/A.
118.249-ET
In Commercial Distribution

  • 07899878030218 ()
118.249-ET

  • Dental implant suprastructure, permanent, preformed
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