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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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EXMOOR - 05060180252595

Myringotomy Kit with Grommets
EXMOOR PLASTICS LIMITED
MK/82/A/E153
In Commercial Distribution

  • 05060180253714 ()
  • 05060180252595 ()
MK82AE153

  • Secretion suction kit

EXMOOR - 05060180252588

Myringotomy Kit with Grommets
EXMOOR PLASTICS LIMITED
MK/82/A/E116
In Commercial Distribution

  • 05060180253707 ()
  • 05060180252588 ()
MK82AE116

  • Secretion suction kit

EXMOOR - 05060180252571

Myringotomy Kit with Grommets
EXMOOR PLASTICS LIMITED
MK/82/A/E114
In Commercial Distribution

  • 05060180253691 ()
  • 05060180252571 ()
MK82AE114

  • Secretion suction kit

EXMOOR - 05060180252564

Myringotomy Kit with Grommets
EXMOOR PLASTICS LIMITED
MK/82/A/E111
In Commercial Distribution

  • 05060180253684 ()
  • 05060180252564 ()
MK82AE111

  • Secretion suction kit

EXMOOR - 05060180252458

Myringotomy Kit with Grommets
EXMOOR PLASTICS LIMITED
MK/72/A/E107
In Commercial Distribution

  • 05060180253264 ()
  • 05060180252458 ()
MK72AE107

  • Secretion suction kit

EXMOOR - 05060180252441

Myringotomy Kit with Grommets
EXMOOR PLASTICS LIMITED
MK/72/A/E106
In Commercial Distribution

  • 05060180253257 ()
  • 05060180252441 ()
MK72AE106

  • Secretion suction kit

EXMOOR - 05060180252434

Myringotomy Kit with Grommets
EXMOOR PLASTICS LIMITED
MK/72/A/E102
In Commercial Distribution

  • 05060180253240 ()
  • 05060180252434 ()
MK72AE102

  • Secretion suction kit

EXMOOR - 05060180252403

Myringotomy Kit with Grommets
EXMOOR PLASTICS LIMITED
MK/72/A/E101
In Commercial Distribution

  • 05060180253233 ()
  • 05060180252403 ()
MK72AE101

  • Secretion suction kit

EXMOOR - 05060180251659

Myringotomy Kit with Grommets
EXMOOR PLASTICS LIMITED
MK/82/A/E108
In Commercial Distribution

  • 05060180253677 ()
  • 05060180251659 ()
MK82AE108

  • Secretion suction kit

EXMOOR - 05060180251642

Myringotomy Kit with Grommets
EXMOOR PLASTICS LIMITED
MK/82/A/E107
In Commercial Distribution

  • 05060180253660 ()
  • 05060180251642 ()
MK82AE107

  • Secretion suction kit

N.A. - J011745301010

Forehead pad with band
DENTAURUM GmbH & Co.KG
745-301-01
In Commercial Distribution

  • J011745301010 ()
  • J011745301011 ()


  • Orthodontic extraoral headgear

Medtronic Reusable Instruments - 00643169323018

COLLET EX1012484 WITH HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1012484
In Commercial Distribution

  • 00643169323018 ()


  • Surgical instrument handle, non-torque-limiting

Response™ - 05414734201223

Electrophysiology Catheter with Lumen
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
401137
In Commercial Distribution

  • 05414734201223 ()

  • Catheter Gauge: 7 French
401137

  • Cardiac mapping catheter, percutaneous, single-use

Response™ - 05414734201193

Electrophysiology Catheter with Lumen
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
401133
In Commercial Distribution

  • 05414734201193 ()

  • Catheter Gauge: 7 French
401133

  • Cardiac mapping catheter, percutaneous, single-use

Response™ - 05414734201179

Electrophysiology Catheter with Lumen
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
401130
In Commercial Distribution

  • 05414734201179 ()

  • Catheter Gauge: 7 French
401130

  • Cardiac mapping catheter, percutaneous, single-use

N.A. - J011000731000

Mosquito forceps with hook
DENTAURUM GmbH & Co.KG
000-731-00
In Commercial Distribution

  • J011000731000 ()


  • Orthodontic pliers

PANAREA™ Interbody System - 10888857309456

Small T-Handle with Hudson
K2M, INC.
7401-90048
In Commercial Distribution

  • 10888857309456 ()
7401-90048

  • Surgical instrument handle, non-torque-limiting

Jenx - 05056235208969

Tray With Hole Sz2
JENX LIMITED
PS33
In Commercial Distribution

  • 05056235208969 ()


  • Walker tray

Response™ - 05414734201209

Electrophysiology Catheter with Lumen
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
401134
In Commercial Distribution

  • 05414734201209 ()

  • Catheter Gauge: 7 French
401134

  • Cardiac mapping catheter, percutaneous, single-use

Response™ - 05414734201186

Electrophysiology Catheter with Lumen
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
401132
In Commercial Distribution

  • 05414734201186 ()

  • Catheter Gauge: 7 French
401132

  • Cardiac mapping catheter, percutaneous, single-use

Medline Industries, Inc. - 10889942047970

BASIN WITH TOWELS SET-LF
MEDLINE INDUSTRIES, INC.
DYNJ0101765
In Commercial Distribution

  • 10889942047970 ()
DYNJ0101765

  • General surgical procedure kit, non-medicated, reusable

Agilis HisPro™ - 05415067032287

Steerable Catheter with Electrodes
ST. JUDE MEDICAL, INC.
DS3H010-38
In Commercial Distribution

  • 05415067032287 ()

  • Catheter Gauge: 10.5000 French
DS3H010-38

  • Vascular guide-catheter, single-use

Palo Alto Corpectomy Cage System - 10888857389120

Small T-Handle with Hudson
K2M, INC.
9501-90004
In Commercial Distribution

  • 10888857389120 ()
9501-90004

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CARDINAL HEALTH - 10888439423976

LACERATION WITH INSTMTS TRAY
Cardinal Health 200, LLC
16-2503A
In Commercial Distribution

  • 50888439423974 ()
  • 10888439423976 ()
16-2503A

  • General surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439393989

CRANIOTOMY WITH BASIN PACK
Cardinal Health 200, LLC
SNE69CREC3
In Commercial Distribution

  • 50888439393987 ()
  • 10888439393989 ()
SNE69CREC3

  • Craniotomy kit

CARDINAL HEALTH - 10888439388978

LAMINECTOMY WITH BASIN PK
Cardinal Health 200, LLC
SNE69LMEC4
In Commercial Distribution

  • 50888439388976 ()
  • 10888439388978 ()
SNE69LMEC4

  • Neurosurgical procedure kit, non-medicated, single-use

SCANLAN® V.I.P.™ Cleaning Tray with Manifold - 00846159034974

Cleaning Tray with Manifold
SCANLAN INTERNATIONAL INC
2162-04
In Commercial Distribution

  • 00846159034974 ()
2162-04

  • Device sterilization/disinfection container, reusable

Jacobson Micro Needle Holder Diamond Dust™ jaw - 00846159005011

with ratchet straight jaw
SCANLAN INTERNATIONAL INC
6006-174
In Commercial Distribution

  • 00846159005011 ()
6006-174

  • Suturing needle holder, reusable

Jacobson Micro Needle Holder Diamond Dust™ jaw - 00846159005004

with ratchet straight jaw
SCANLAN INTERNATIONAL INC
6006-170
In Commercial Distribution

  • 00846159005004 ()
6006-170

  • Suturing needle holder, reusable

CARDINAL HEALTH - 10888439463477

LAMINECTOMY WITH BASIN PK
Cardinal Health 200, LLC
SNE69LMEC5
In Commercial Distribution

  • 50888439463475 ()
  • 10888439463477 ()
SNE69LMEC5

  • Neurosurgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439503661

LACERATION WITH INSTMTS TRAY
Cardinal Health 200, LLC
16-2503B
In Commercial Distribution

  • 50888439503669 ()
  • 10888439503661 ()
16-2503B

  • General surgical procedure kit, non-medicated, single-use

Medtronic Reusable Instruments - 00613994968548

SCREWDRIVER EX0311002 WITH WINGS
MEDTRONIC SOFAMOR DANEK, INC.
EX0311002
In Commercial Distribution

  • 00613994968548 ()


  • Orthopaedic implant driver

APEX - 04713025000080

XT Auto with Humidifier
Wellell Inc.
9S-005720, 9S-006500
In Commercial Distribution

  • 14713025000087 ()
  • 04713025000080 ()


  • Home CPAP unit
  • Heated respiratory humidifier

APEX - 04713025000066

XT Prime with Humidifier
Wellell Inc.
9S-005580, 9S-006500
In Commercial Distribution

  • 14713025000063 ()
  • 04713025000066 ()


  • Home CPAP unit
  • Heated respiratory humidifier

APEX - 04713025000042

XT Sense with Humidifier
Wellell Inc.
9S-005530, 9S-006500
In Commercial Distribution

  • 14713025000049 ()
  • 04713025000042 ()


  • Home CPAP unit
  • Heated respiratory humidifier

APEX - 04713025000028

XT Fit with Humidifier
Wellell Inc.
9S-005500, 9S-006500
In Commercial Distribution

  • 14713025000025 ()
  • 04713025000028 ()


  • Home CPAP unit
  • Heated respiratory humidifier

SCANLAN® Scissors - 00846159031324

Weichel Scissors with Guide
SCANLAN INTERNATIONAL INC
1-8483
In Commercial Distribution

  • 00846159031324 ()
1-8483

  • General-purpose surgical scissors, reusable

Jacobson Micro Needle Holder Diamond Dust™ jaw - 00846159020496

with ratchet curved jaw
SCANLAN INTERNATIONAL INC
6006-176
In Commercial Distribution

  • 00846159020496 ()
6006-176

  • Suturing needle holder, reusable

CARDINAL HEALTH - 10888439463835

CRANIOTOMY WITH BASIN PACK
Cardinal Health 200, LLC
SNE69CREC4
In Commercial Distribution

  • 50888439463833 ()
  • 10888439463835 ()
SNE69CREC4

  • Craniotomy kit

Jacobson Micro Needle Holder Diamond Dust™ jaw - 00846159023282

with ratchet curved jaw
SCANLAN INTERNATIONAL INC
6006-172
In Commercial Distribution

  • 00846159023282 ()
6006-172

  • Suturing needle holder, reusable

CARDINAL HEALTH - 10888439523973

KNEE WITH ACL RECONSTRUCTION
Cardinal Health 200, LLC
SOP34ARKS1
In Commercial Distribution

  • 50888439523971 ()
  • 10888439523973 ()
SOP34ARKS1

  • Orthopaedic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439529838

CATARACT WITH TUBING PACK
Cardinal Health 200, LLC
SEY44CAASC
In Commercial Distribution

  • 50888439529836 ()
  • 10888439529838 ()
SEY44CAASC

  • Ophthalmic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10888439513332

KIT, RECOVERY WITH PILLOW
Cardinal Health 200, LLC
OMS440132B
In Commercial Distribution

  • 50888439513330 ()
  • 10888439513332 ()
OMS440132B

  • General surgical procedure kit, non-medicated, single-use

PCD - 04546540907035

Precision System with Needle
STRYKER CORPORATION
0506485000
Not in Commercial Distribution

  • 34546540907036 ()
  • 04546540907035 ()

  • Needle Gauge: 13.0 Gauge
0506-485-000

  • Orthopaedic cement preparation/delivery kit

PCD - 04546540907011

Precision System with Needle
STRYKER CORPORATION
0506483000
Not in Commercial Distribution

  • 34546540907012 ()
  • 04546540907011 ()

  • Needle Gauge: 11.0 Gauge
0506-483-000

  • Orthopaedic cement preparation/delivery kit

PCD - 04546540906991

Precision System with Needle
STRYKER CORPORATION
0506482000
Not in Commercial Distribution

  • 34546540906992 ()
  • 04546540906991 ()

  • Needle Gauge: 10.0 Gauge
0506-482-000

  • Orthopaedic cement preparation/delivery kit

Bending Forceps - 09120069811285

Bending Forceps, With Cutter
I.T.S. GmbH
KH.267.16
In Commercial Distribution

  • 09120069811285 ()
KH.267.16

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

Forceps - 09120069810967

Forceps, With Gauge Function
I.T.S. GmbH
62830
In Commercial Distribution

  • 09120069810967 ()
62830

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

NA - 04546540156198

Reduction Instrument, With Scale
Stryker GmbH
07-40101
In Commercial Distribution

  • 04546540156198 ()

  • Length: 7.0 Centimeter
07-40101

  • Orthopaedic surgical procedure kit, non-medicated, reusable

NA - 04546540237989

BONE PLATE, WITH BAR
Stryker Leibinger GmbH & Co. KG
54-05106
In Commercial Distribution

  • 04546540237989 ()

  • Bar Length: 4.4 Millimeter
  • Number of Screw Holes: 4.0 Holes
54-05106

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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