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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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Tandem Mobi Starter Kit - 00389152408170

with Control-IQ 7.X
Tandem Diabetes Care, Inc.
1014081
In Commercial Distribution

  • 00389152408170 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm

Tandem Mobi Starter Kit - 00389152311777

with Control-IQ 7.X
Tandem Diabetes Care, Inc.
1013117
In Commercial Distribution

  • 00389152311777 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm

Pressure Syringe - D701PSO2

Pressure syringe with handle
PULPDENT CORPORATION
PS-O
In Commercial Distribution

  • D701PSO2 ()


  • Endodontic filling material condenser

CARDINAL HEALTH - 10888439006506

KIT, RECOVERY WITH PILLOW
Cardinal Health 200, LLC
OMS4401323
In Commercial Distribution

  • 50888439006504 ()
  • 10888439006506 ()
OMS4401323

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

Brickyard Stand-Alone ALIF - 00843210180281

U-Joint Awl With Sleeve
Altus Spine, LLC
1030-0100A
In Commercial Distribution

  • 00843210180281 ()


  • Bone awl, reusable

Indy Standalone - 00843210147024

U-Joint Awl With Sleeve
Altus Spine, LLC
1030-0100A
In Commercial Distribution

  • 00843210147024 ()


  • Bone awl, reusable

Senti - 04260223142529

Senti device with touchscreen
PATH medical GmbH
100097
Not in Commercial Distribution

  • 04260223142529 ()


  • Tone audiometer

MaxMoreSpine - 04260200312631

MaxDisc Tray with lid
Hoogland Spine Products GmbH
1001-IS 011
In Commercial Distribution

  • 04260200312631 ()


  • Instrument tray, 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

ManoScan - 04260167482491

ESO With Extended Tip
Given Imaging, Inc.
RFG-8000-15
In Commercial Distribution

  • 04260167482491 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482439

ESO With Extended Tip
Given Imaging, Inc.
800015
In Commercial Distribution

  • 04260167482439 ()


  • Manometric gastrointestinal motility analysis system

GPC - 08904400200027

Curette with Fibre Handle
GPC MEDICAL LIMITED
COG803
In Commercial Distribution

  • 08904400200027 ()


  • General external orthopaedic fixation system implantation kit, reusable

BMT Medizintechnik GmbH - 04251725217815

VIAL SYRINGE WITH ASPIRATOR
BMT Medizintechnik GmbH
STF-1
In Commercial Distribution

  • 04251725217815 ()
STF-1

  • Dental anaesthesia syringe, reusable

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

BC-1 - 09120041051661

Audiometric receiver with headband
BHM-Tech Produktionsgesellschaft m.b.H.
BC-1-BONE-W-HEADBAND/GR7024
In Commercial Distribution

  • 09120041051661 ()
77735155

  • Auditory cranial bone vibrator

BC-1 - 09120041051500

Audiometric receiver with headband
BHM-Tech Produktionsgesellschaft m.b.H.
BC-1-BONE-W-HEADBAND
In Commercial Distribution

  • 09120041051500 ()
77735020

  • Auditory cranial bone vibrator

Elemax® Cortical Cancellous Spacer - 00846468062712

Inserter Shaft with Stop
Pioneer Surgical Technology, Inc.
30-CC-INSRTSHAFT-S
Not in Commercial Distribution

  • 00846468062712 ()


  • General internal orthopaedic fixation system implantation kit

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

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

Rad-97 - 00843997014199

Home Use with camera
MASIMO CORPORATION
9784
In Commercial Distribution

  • 00843997014199 ()
  • 00843997013673 ()


  • Pulse Co-oximeter

Rad-97 - 00843997013864

Rad-97 with NomoLine Capnography
MASIMO CORPORATION
9868
In Commercial Distribution

  • 00843997013864 ()


  • Pulse Co-oximeter

Rad-97 - 00843997012782

Rad-97 with NomoLine Capnography
MASIMO CORPORATION
9799
In Commercial Distribution

  • 00843997012782 ()
  • 00843997013710 ()
9799

  • Pulse Co-oximeter

RAD-G - 00843997008013

Rad-G, Temp, with sensor
MASIMO CORPORATION
9210
In Commercial Distribution

  • 00843997000628 ()
  • 00843997008013 ()


  • Pulse oximeter

Medline - 10080196030552

DRAPE TOP WITH ABC
MEDLINE INDUSTRIES, INC.
SPT-4215SCS
In Commercial Distribution

  • 40080196030553 ()
  • 10080196030552 ()
SPT-4215SCS

  • Patient surgical drape, single-use, non-sterile

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

CARDINAL HEALTH - 10888439291926

LAMINECTOMY WITH BASIN PK
Cardinal Health 200, LLC
SNE69LMEC3
In Commercial Distribution

  • 50888439291924 ()
  • 10888439291926 ()
SNE69LMEC3

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

CARDINAL HEALTH - 10888439463835

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

  • 50888439463833 ()
  • 10888439463835 ()
SNE69CREC4

  • Craniotomy kit

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

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

NA - 00845384005605

Nitrogen Regulator with Schrader
Anspach Effort, The
N/REGULATOR
Not in Commercial Distribution

  • 00845384005605 ()
N/REGULATOR

  • Pneumatic surgical power tool hose

Medline - 10080196722860

PACK,BASIC,WITH GOWNS
MEDLINE INDUSTRIES, INC.
DYNJP1025
In Commercial Distribution

  • 10080196722860 ()
DYNJP1025

  • Surgical/examination garment kit

Medline - 10080196722846

DBD-PACK,BASIC,WITH GOWNS
MEDLINE INDUSTRIES, INC.
DYNJP1015
In Commercial Distribution

  • 40080196722847 ()
  • 10080196722846 ()
DYNJP1015

  • Patient surgical drape, 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

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 - 00846159005004

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

  • 00846159005004 ()
6006-170

  • Suturing needle holder, reusable

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

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

ATEC Biologics - 00844856089679

ALLOGRAFT TAMP WITH STOP
ALPHATEC SPINE, INC.
67110
In Commercial Distribution

  • 00844856089679 ()


  • Surgical tamp, reusable

VARIAX - 04546540540553

Forceps with Grasping Lips
Stryker GmbH
64-20129
In Commercial Distribution

  • 04546540540553 ()
64-20129

  • Bone holding forceps

NA - 04546540490841

FRACTURE PLATE, WITH BAR
Stryker Leibinger GmbH & Co. KG
11-15505
In Commercial Distribution

  • 04546540490841 ()

  • Number of Screw Holes: 4.0 Holes
  • Bar Length: 6.0 Millimeter
11-15505

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

NA - 04546540490315

PLATE, CURVED, WITH BAR
Stryker Leibinger GmbH & Co. KG
11-06754
In Commercial Distribution

  • 04546540490315 ()

  • Bar Length: 2.4 Millimeter
  • Number of Screw Holes: 4.0 Holes
11-06754

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

NA - 04546540490278

PLATE, STRAIGHT, WITH BAR
Stryker Leibinger GmbH & Co. KG
11-06704
In Commercial Distribution

  • 04546540490278 ()

  • Number of Screw Holes: 4.0 Holes
  • Bar Length: 2.4 Millimeter
11-06704

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

NA - 04546540489920

Y-PLATE, WITH 4MM BAR
Stryker Leibinger GmbH & Co. KG
11-05151
In Commercial Distribution

  • 04546540489920 ()

  • Bar Length: 4.4 Millimeter
  • Number of Screw Holes: 5.0 Holes
11-05151

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