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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TOTAL KNEE M PACK
Cardinal Health 200, LLC
SOP18TMG11
In Commercial Distribution

  • 50197106289875 ()
  • 10197106289877 ()
SOP18TMG11

  • Orthopaedic surgical procedure kit, non-medicated, single-use
TOTAL KNEE M PACK
Cardinal Health 200, LLC
SOP18TMGHL
In Commercial Distribution

  • 50197106280063 ()
  • 10197106280065 ()
SOP18TMGHL

  • Orthopaedic surgical procedure kit, non-medicated, single-use
MAS Midline Trial, M
Nuvasive, Inc.
1809622
In Commercial Distribution

  • 00887517709486 ()


  • Lumbar interspinous decompression instrument set, reusable
CUSTOM M TEST TRAY
Cardinal Health 200, LLC
SBB32MBME9
In Commercial Distribution

  • 50197106329472 ()
  • 10197106329474 ()
SBB32MBME9

  • General surgical procedure kit, non-medicated, single-use
TOTAL KNEE M PACK
Cardinal Health 200, LLC
SOP18TMG12
In Commercial Distribution

  • 50197106370542 ()
  • 10197106370544 ()
SOP18TMG12

  • Orthopaedic surgical procedure kit, non-medicated, single-use
Siesta Nasal Mask(M)
BMC Medical Co., Ltd.
N5B(Medium)
In Commercial Distribution

  • 16948538368197 ()
  • 06948538368190 ()


  • CPAP/BPAP nasal mask, reusable
Siesta Nasal Mask (M)
BMC Medical Co., Ltd.
N5B (Medium)
In Commercial Distribution

  • 16948538367596 ()
  • 06948538367599 ()


  • CPAP/BPAP nasal mask, reusable
GLENOID REAM BIT M
Smith & Nephew, Inc.
RMB-0990-818-02
In Commercial Distribution

  • 00885556811634 ()
RMB-0990-818-02

  • Bone-resection orthopaedic reamer, reusable
GLENOID INSERTER TIP M
Smith & Nephew, Inc.
INS-0990-830-02
In Commercial Distribution

  • 00885556811016 ()
INS-0990-830-02

  • Orthopaedic inorganic implant inserter/extractor, reusable
FIN-LOCK GLENOID TRIAL. M
Smith & Nephew, Inc.
TRL-0926-030-02A
In Commercial Distribution

  • 00885556863428 ()
TRL-0926-030-02A

  • Shoulder glenoid fossa prosthesis trial
NON-CANNULATED GLENOID REAMER. M
Smith & Nephew, Inc.
RMR-0926-02N
In Commercial Distribution

  • 00885556861868 ()
RMR-0926-02N

  • Bone-resection orthopaedic reamer, reusable
CANNULATED GLENOID REAMER. M
Smith & Nephew, Inc.
RMR-0926-02C
In Commercial Distribution

  • 00885556861851 ()
RMR-0926-02C

  • Bone-resection orthopaedic reamer, reusable
NON-CANNULATED BOWTIE REAMER. M
Smith & Nephew, Inc.
RMR-0926-02BN
In Commercial Distribution

  • 00885556861844 ()
RMR-0926-02BN

  • Bone-resection orthopaedic reamer, reusable
CANNULATED BOWTIE REAMER. M
Smith & Nephew, Inc.
RMR-0926-02BC
In Commercial Distribution

  • 00885556861837 ()
RMR-0926-02BC

  • Bone-resection orthopaedic reamer, reusable
FLEXIBLE I/M ROD
Smith & Nephew, Inc.
E0017558-7
In Commercial Distribution

  • 00885556867969 ()
E0017558-7

  • Orthopaedic prosthesis implantation positioning instrument, reusable
NUGRIP TEMPLATE SZ. M
Smith & Nephew, Inc.
TMP-443-M
In Commercial Distribution

  • 00885556857892 ()
TMP-443-M

  • Surgical implant template, reusable
FINISHING SHAPER SZ. M
Smith & Nephew, Inc.
SHP-443-M
In Commercial Distribution

  • 00885556857861 ()
SHP-443-M

  • Bone cutter
ALIGNMENT GUIDE. E/M
Smith & Nephew, Inc.
ALG-100-00
In Commercial Distribution

  • 00885556856475 ()
ALG-100-00

  • Orthopaedic implant aiming arm
COMBO INSERTER/IMPACTOR. M
Smith & Nephew, Inc.
IMP-0926-030-02A
In Commercial Distribution

  • 00885556860748 ()
IMP-0926-030-02A

  • Orthopaedic implant impactor, reusable
TSS PEGGED GLENOID M
Smith & Nephew, Inc.
GLN-0920-030-02P
In Commercial Distribution

  • 00885556860397 ()
GLN-0920-030-02P

  • Shoulder glenoid fossa prosthesis, prefabricated
TSS KEELED GLENOID M
Smith & Nephew, Inc.
GLN-0920-030-02K
In Commercial Distribution

  • 00885556860380 ()
GLN-0920-030-02K

  • Shoulder glenoid fossa prosthesis, prefabricated
BASE Guide, Single M
Nuvasive, Inc.
6950113
In Commercial Distribution

  • 00887517700339 ()


  • Surgical instrument/implant depth limiter, reusable
RETRACTOR X0514018 M/L
MEDTRONIC SOFAMOR DANEK, INC.
X0514018
In Commercial Distribution

  • 00763000177652 ()


  • Surgical retractor/retraction system blade, reusable
OLH - Boot M - B
ADSM
6883314B
Not in Commercial Distribution

  • 03701091006281 ()
6883314B

  • Operating table orthopaedic extension, non-powered
M ECMO HEART PACK
Cardinal Health 200, LLC
SCV15HPFCA
In Commercial Distribution

  • 50198956112092 ()
  • 10198956112094 ()
SCV15HPFCA

  • Cardiothoracic surgical procedure kit, medicated, single-use
H D M CESAREAN
Cardinal Health 200, LLC
SMA30DAPR7
In Commercial Distribution

  • 50195594562678 ()
  • 10195594562670 ()
SMA30DAPR7

  • Obstetrical/gynaecological surgical procedure kit, medicated
H D M CESAREAN
Cardinal Health 200, LLC
SMA30DAPR9
In Commercial Distribution

  • 50195594586049 ()
  • 10195594586041 ()
SMA30DAPR9

  • Obstetrical/gynaecological surgical procedure kit, medicated
H D M CESAREAN
Cardinal Health 200, LLC
SMA30DAP10
In Commercial Distribution

  • 50195594633651 ()
  • 10195594633653 ()
SMA30DAP10

  • Obstetrical/gynaecological surgical procedure kit, medicated
TOTAL KNEE M PACK
Cardinal Health 200, LLC
SOP18TMG10
In Commercial Distribution

  • 50197106216765 ()
  • 10197106216767 ()
SOP18TMG10

  • Orthopaedic surgical procedure kit, non-medicated, single-use
I/M DRILL GUIDE
Smith & Nephew, Inc.
E0016756-2
In Commercial Distribution

  • 00885556770481 ()
E0016756-2

  • Surgical drill guide, reusable
H D M CESAREAN
Cardinal Health 200, LLC
SMA30DAPR8
In Commercial Distribution

  • 50195594576620 ()
  • 10195594576622 ()
SMA30DAPR8

  • Obstetrical/gynaecological surgical procedure kit, medicated
H D M CESAREAN
Cardinal Health 200, LLC
SMA30DAPR6
In Commercial Distribution

  • 50195594551337 ()
  • 10195594551339 ()
SMA30DAPR6

  • Obstetrical/gynaecological surgical procedure kit, medicated
TOTAL KNEE M PACK
Cardinal Health 200, LLC
SOP18TMGH9
In Commercial Distribution

  • 50195594664266 ()
  • 10195594664268 ()
SOP18TMGH9

  • Orthopaedic surgical procedure kit, non-medicated, single-use
SET CHARGER BTE M
Ws Audiology Usa, Inc.
CHARGER BTE M
In Commercial Distribution

  • 05714880247282 ()
21040842

  • Noninvasive device battery charger
Pedicle Hook Size (M)
K2M, INC.
2901-80044
In Commercial Distribution

  • 10888857039544 ()

  • Medium
2901-80044

  • Bone-screw internal spinal fixation system hook
Laminar Hook Size (M)
K2M, INC.
2901-80041
In Commercial Distribution

  • 10888857039513 ()

  • Medium
2901-80041

  • Bone-screw internal spinal fixation system hook
Pedicle Hook Size (M)
K2M, INC.
3001-80603
In Commercial Distribution

  • 10888857052062 ()

  • Medium
  • Outer Diameter: 4.5 Millimeter
3001-80603

  • Bone-screw internal spinal fixation system hook
No Description
HELENA LABORATORIES CORPORATION
552229
In Commercial Distribution

  • M5255522290 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
THE BINDING SITE GROUP LIMITED
NK623.T.A
In Commercial Distribution

  • 05051700016919 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
The HomeChoice PRO Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
BAXTER INTERNATIONAL INC.
5C8310R
In Commercial Distribution

  • 00085412026350 ()
5C8310R

  • Peritoneal dialysis system
The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
BAXTER INTERNATIONAL INC.
5C4471
In Commercial Distribution

  • 00085412007021 ()
5C4471

  • Peritoneal dialysis system
10' PVC, .050" ID X .108" OD M/M Luers, Bulk
WESTMED, INC.
0802
Not in Commercial Distribution

  • 10709078013727 ()
  • 00709078007040 ()


  • Nasal oxygen cannula, carbon-dioxide-sampling
15-20 mmHg CORESPORT ARM SLEEVES M / M BLACK X-STATIC / NEGRO X-STATIC
KNIT-RITE, INC
57722
In Commercial Distribution

  • 00721734577223 ()


  • Compression/pressure sock/stocking, single-use
15-20 mmHg CORESPORT ARM SLEEVES M / M WHITE X-STATIC / BLANCO X-STATIC
KNIT-RITE, INC
57522
In Commercial Distribution

  • 00721734575229 ()


  • Compression/pressure sock/stocking, single-use
15-20 mmHg CORESPORT LEG SLEEVES M / M BLACK X-STATIC / NEGRO X-STATIC
KNIT-RITE, INC
67722
In Commercial Distribution

  • 00721734677220 ()


  • Compression/pressure sock/stocking, single-use
15-20 mmHg CORESPORT LEG SLEEVES M / M WHITE X-STATIC / BLANCO X-STATIC
KNIT-RITE, INC
67522
In Commercial Distribution

  • 00721734675226 ()


  • Compression/pressure sock/stocking, single-use
SWIVEL OXYGEN TUBING CONNECTOR M/M, BARBED ENDS CA=100/BAG
COMPASS HEALTH BRANDS CORP.
SWVL-ROS
In Commercial Distribution

  • 00092237626276 ()


  • Oxygen administration tubing
DreamWear Full Mask, M, w/M Frame w/o Headgear, Global
Respironics, Inc.
DreamWear Full Mask Medium, w/Medium Frame w/o Headgear, Global
In Commercial Distribution

  • 00606959045927 ()
1133406

  • CPAP/BPAP nasal mask, reusable
OptiLife Mask M, L Pillows, and M, L, LN Cradle - JPN
Respironics, Inc.
00
In Commercial Distribution

  • 00606959038189 ()
1036824

  • CPAP/BPAP nasal mask, reusable
OptiLife Mask P, S, M Pillows, and S, M Cradle - JPN
Respironics, Inc.
00
In Commercial Distribution

  • 00606959038172 ()
1036823

  • CPAP/BPAP nasal mask, reusable
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