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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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Indigo System - 00815948022577

CAT12 115 New HTORQ shape plus Lightning
PENUMBRA, INC.
LITNG12HTORQ115-A
In Commercial Distribution

  • 00815948022577 ()


  • Thrombectomy suction catheter
  • Suction/irrigation tubing, single-use

Indigo System - 00815948022560

CAT12 100 New XTORQ shape plus Lightning
PENUMBRA, INC.
LITNG12XTORQ100-A
In Commercial Distribution

  • 00815948022560 ()


  • Thrombectomy suction catheter
  • Suction/irrigation tubing, single-use

Indigo System - 00815948022553

CAT12 100 New HTORQ shape plus Lightning
PENUMBRA, INC.
LITNG12HTORQ100-A
In Commercial Distribution

  • 00815948022553 ()


  • Thrombectomy suction catheter
  • Suction/irrigation tubing, single-use

Surgical Direct - B382SD905446180

7 inch New Orleans Needle Holder, TC
Surgical Direct, Inc.
SD90544618
In Commercial Distribution

  • B382SD905446180 ()
SD90544618

  • Suturing needle holder, reusable

Surgical Direct - B382SD915082000

10 inch New Port Lateral Vaginal Retractor
Surgical Direct, Inc.
SD91508200
In Commercial Distribution

  • B382SD915082000 ()
SD91508200

  • Vaginal speculum, reusable

Top Quality Manufacturing - TQ26FM2180611

TQMPL Face Mask - ASTM 1 - White - New
TOP QUALITY MANUFACTURING, INC.
FM2-1806
In Commercial Distribution

  • TQ26FM2180610 ()
  • TQ26FM2180611 ()


  • Surgical/medical face mask, non-antimicrobial, single-use

Top Quality Manufacturing - TQ26FM2180511

TQMPL Face Mask - ASTM 1 - Yellow - New
TOP QUALITY MANUFACTURING, INC.
FM2-1805
In Commercial Distribution

  • TQ26FM2180510 ()
  • TQ26FM2180511 ()


  • Surgical/medical face mask, non-antimicrobial, single-use

Top Quality Manufacturing - TQ26FM2180211

TQMPL Face Mask - ASTM 1 - Pink - New
TOP QUALITY MANUFACTURING, INC.
FM2-1802
In Commercial Distribution

  • TQ26FM2180210 ()
  • TQ26FM2180211 ()


  • Surgical/medical face mask, non-antimicrobial, single-use

Top Quality Manufacturing - TQ26FM2180111

TQMPL Face Mask - ASTM 1 - Blue - New
TOP QUALITY MANUFACTURING, INC.
FM2-1801
In Commercial Distribution

  • TQ26FM2180110 ()
  • TQ26FM2180111 ()


  • Surgical/medical face mask, non-antimicrobial, single-use

Dukal - 10665973014835

New Sponge 4" x 4" 4-Ply, Sterile
Dukal LLC
6125
In Commercial Distribution

  • 20665973014832 ()
  • 10665973014835 ()
  • 30665973014839 ()
  • 00665973014838 ()
6125

  • Non-woven gauze pad

Dukal - 10665973014828

New Sponge 4" x 4" 4-Ply, Sterile
Dukal LLC
6124
In Commercial Distribution

  • 20665973014825 ()
  • 10665973014828 ()
  • 30665973014822 ()
  • 00665973014821 ()
6124

  • Non-woven gauze pad

Dukal - 10665973014811

New Sponge 3" x 3" 4-Ply, Sterile
Dukal LLC
6123
In Commercial Distribution

  • 20665973014818 ()
  • 10665973014811 ()
  • 30665973014815 ()
  • 00665973014814 ()
6123

  • Non-woven gauze pad

Dukal - 10665973014804

New Sponge 2" x 2" 4-Ply, Sterile
Dukal LLC
6122
In Commercial Distribution

  • 30665973014808 ()
  • 20665973014801 ()
  • 10665973014804 ()
  • 00665973014807 ()
6122

  • Non-woven gauze pad

CARDINAL HEALTH - 10198956012578

IR ANGIO SET UP PACK NEW HAN
Cardinal Health 200, LLC
SAN23IANL2
In Commercial Distribution

  • 50198956012576 ()
  • 10198956012578 ()
SAN23IANL2

  • Cardiothoracic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10197106964330

IR ANGIO SET UP PACK NEW HAN
Cardinal Health 200, LLC
SAN23IANL1
In Commercial Distribution

  • 50197106964338 ()
  • 10197106964330 ()
SAN23IANL1

  • Cardiothoracic surgical procedure kit, medicated, single-use

PlasmaJet Neutral Plasma Surgery System - M397PS103130NZ0

PlasmaJet Ultra Plus Console System (New Zealand)
PLASMA SURGICAL, INC
PS10-3130-NZ
In Commercial Distribution

  • M397PS103130NZ0 ()
PS10-3130-NZ

  • Plasma surgical system

PlasmaJet Neutral Plasma Surgery System - M397PS102130NZ0

PlasmaJet V3 Plus Console System (New Zealand)
PLASMA SURGICAL, INC
PS10-2130-NZ
In Commercial Distribution

  • M397PS102130NZ0 ()
PS10-2130-NZ

  • Plasma surgical system

BAUM - 00810010924407

Reservoir Gasket for Standby Model - New Style
W. A. BAUM CO., INC.
2255NS
In Commercial Distribution

  • 00810010924407 ()
2255NS

  • Aneroid manual sphygmomanometer

BAUM - 00810010923479

Complete Scale (New Style) for Standby Model
W. A. BAUM CO., INC.
2271NS
In Commercial Distribution

  • 00810010923479 ()
2271NS

  • Aneroid manual sphygmomanometer

BAUM - 00810010923462

Scale Only (New Style) for Standby Model
W. A. BAUM CO., INC.
2270NS
In Commercial Distribution

  • 00810010923462 ()
2270NS

  • Aneroid manual sphygmomanometer

NA - 00885554027341

SM JOINT GRASPR W/ NEW LOCKING RATCHET
Smith & Nephew, Inc.
72203612
In Commercial Distribution

  • 00885554027341 ()
72203612

  • Rigid endoscopic grasping forceps, reusable

N/A - 00885074421490

CASE 9568013 MAST QUADRANT OUTR TRAY NEW
MEDTRONIC SOFAMOR DANEK, INC.
9568013
In Commercial Distribution

  • 00885074421490 ()


  • Instrument tray, reusable

N/A - 00885074421469

CASE 8390310 MAST QUAD LGCY OUTR NEW
MEDTRONIC SOFAMOR DANEK, INC.
8390310
In Commercial Distribution

  • 00885074421469 ()


  • Instrument tray, reusable

CARDINAL HEALTH - 10197106544709

OPEN HEART RE OP PACK NEW HAN
Cardinal Health 200, LLC
SCV23ORNLA
In Commercial Distribution

  • 50197106544707 ()
  • 10197106544709 ()
SCV23ORNLA

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

CARDINAL HEALTH - 10197106544051

IR ANGIO SET UP PACK NEW HAN
Cardinal Health 200, LLC
SAN23IANLA
In Commercial Distribution

  • 50197106544059 ()
  • 10197106544051 ()
SAN23IANLA

  • Cardiothoracic surgical procedure kit, medicated, single-use

Navios EX - 15099590683276

NAVIOS EX TETRA SOFTWARE V2.0 NEW USER
BECKMAN COULTER IRELAND INC.
TETRA SOFTWARE V2.0 NEW USER
In Commercial Distribution

  • 15099590683276 ()
B91240

  • Laboratory instrument/analyser application software IVD

Bausch + Lomb - 00757770430864

BULB SM NEW MDL F/N300 - N307
Bausch & Lomb Incorporated
N0312 S
In Commercial Distribution

  • 00757770430864 ()
N0312 S

  • Surgical binoculars, reusable

Bausch + Lomb - 00757770418190

DSCT-PK CRBTREE NEW SM 1 1/2MM
Bausch & Lomb Incorporated
N1705 83JS
In Commercial Distribution

  • 00757770418190 ()
N1705 83JS

  • Middle ear pick

BD Sharps Collector - 00382903050765

SHARPS COLL CHEMO 3GAL YELLOW NEW CAP
BECTON, DICKINSON AND COMPANY
305076
In Commercial Distribution

  • 00382903050765 ()
  • 50382903050760 ()

  • Total Volume: 11.3 Liter
305076

  • Sharps container

Angel Whole Blood Processing System - 00852714003071

Angel Whole Blood Processing System Machine (EU) New with 966003051 EU Case Label for New EU Machines
NUO THERAPEUTICS INC
976000101
In Commercial Distribution

  • 00852714003071 ()


  • Apheresis system

Sensimatic® - 00810000520046

New Indifferent Plate & Red Cable for Sensimatic® 600SE (Complies with New FDA Lead Wire Regulations)(Korea)
PARKELL, INC.
D601-K
Not in Commercial Distribution

  • 00810000520046 ()
D601-K

  • Electrosurgical return electrode, reusable

Sofreliner Tough - 04548190234110

S Paste
TOKUYAMA DENTAL CORPORATION
23411
In Commercial Distribution

  • 04548190234110 ()


  • Denture reliner, elastic, long-term
  • Denture reliner, elastic, short-term

Sofreliner Tough - 04548190234011

S Kit
TOKUYAMA DENTAL CORPORATION
23401
In Commercial Distribution

  • 04548190234011 ()


  • Denture reliner, elastic, short-term
  • Denture reliner, elastic, long-term

Air Ranger Pro - 00841965103333

Assy,MatPkg,54",S3K,NSM
Tridien Medical
New Source
In Commercial Distribution

  • 00841965103333 ()
53-SM52S3-54NSM

  • Alternating-pressure bed mattress overlay system

Air Ranger Pro - 00841965103319

Assy,Ctlr/Pkg,SIV 3K Plus,NSM
Tridien Medical
New Source
In Commercial Distribution

  • 00841965103319 ()
23SM3000-ARPP

  • Alternating-pressure bed mattress overlay system

Air Ranger Pro - 00841965103326

Assy,Mattress/Pkg,SIV 3K Plus,
Tridien Medical
New Source
In Commercial Distribution

  • 00841965103326 ()
53-SM52S3-48NSM

  • Alternating-pressure bed mattress overlay system

babaka - 06950715503294

Back Brace
Cofoe Medical Technology Co.,Ltd
New E+
In Commercial Distribution

  • 06950715503294 ()


  • Lumbar spine orthosis

babaka - 06950715503287

Back Brace
Cofoe Medical Technology Co.,Ltd
New L
In Commercial Distribution

  • 06950715503287 ()


  • Lumbar spine orthosis

Cofoe - 06950715501597

It is intended for use in correcting improper posture, such as hunching or slouching, and improving overall body alignment. It is suitable for both adults and children who need assistance in maintaining proper posture.
Cofoe Medical Technology Co.,Ltd
New E+
In Commercial Distribution

  • 06950715501597 ()


  • Lumbar spine orthosis

Cofoe - 06950715501566

It is intended for use in correcting improper posture, such as hunching or slouching, and improving overall body alignment. It is suitable for both adults and children who need assistance in maintaining proper posture.
Cofoe Medical Technology Co.,Ltd
New L
In Commercial Distribution

  • 06950715501566 ()


  • Lumbar spine orthosis
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