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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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CellaVision® Server Softwaren, Upgrade to next generation - 07350040976036

The CellaVision Server Software is a network optimization design to create workflow efficency in lager organizations and enables easy data transfer from all connected analyzers to a centralized database residing on a single server.
Cellavision AB
CSS-0000NG
In Commercial Distribution

  • 07350040976036 ()
CSS-0000NG

  • Medical networking interface unit

DISP ECG LW,6LD,SNAP TO MULTI,INTERMED - 90840828101021

DISP ECG LW,6LD,SNAP TO MULTI,INTERMED
CURBELL MEDICAL PRODUCTS, INC.
DLW-06AD-40AM-3000
Not in Commercial Distribution

  • 90840828101496 ()
  • 90840828101021 ()
  • 90840828101175 ()
18602

  • Electrocardiographic electrode, single-use

DISP ECG LW,5LD,PINCH TO MULTIL,INTERMED - 90840828100970

DISP ECG LW,5LD,PINCH TO MULTIL,INTERMED
CURBELL MEDICAL PRODUCTS, INC.
DLW-05BD-40AM-3000
Not in Commercial Distribution

  • 90840828101458 ()
  • 90840828100970 ()
  • 90840828101137 ()
18597

  • Electrocardiographic electrode, single-use

BRAEBON Male Snap to Female Safety Pin Adapter - B14003590

Cable for connecting sensors to a device.
Braebon Medical Corporation
0359
In Commercial Distribution

  • B14003590 ()
0359

  • Electrical-only medical device connection cable, reusable

MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) - B126KR62150

A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroid peroxidase (TPO) receptor in human serum.
KRONUS, INC.
KR6215
In Commercial Distribution

  • B126KR62150 ()
KR6215

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, radioimmunoassay

MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) - B126KR62100

A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroid peroxidase (TPO) receptor in human serum.
KRONUS, INC.
KR6210
In Commercial Distribution

  • B126KR62100 ()
KR6210

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, radioimmunoassay

Assist to Hairline Device - Reusable (AHD-R), 6 Pack - 00810072351173

Assists in creating the hairline on the forehead for hair restoration. There are six per pack sold and they are all reusable.
Cole Instruments Inc
AHD-R, 6 pack
In Commercial Distribution

  • 00810072351173 ()
410.002

  • Surgical implant template, reusable

Monopolar High Frequency Cord Male to Female Connector - 00801741077289

Monopolar High Frequency Cord Male to Female Connector
Davol Inc.
5601100
Not in Commercial Distribution

  • 00801741077289 ()
  • 10801741077286 ()
5601100

  • Electrical-only medical device connection cable, reusable

Align® TO Trans-Obturator Urethral Support System - Halo - 00801741016226

ALIGN® TO Urethral Support System, Halo
C. R. Bard, Inc.
BRD500HL
Not in Commercial Distribution

  • 00801741016226 ()
  • 10801741016223 ()
BRD500HL

  • Female stress urinary incontinence surgical mesh-sling, synthetic polymer

Align® TO Trans-Obturator Urethral Support System - Hook - 00801741016219

ALIGN® TO Urethral Support System, Hook
C. R. Bard, Inc.
BRD400HK
Not in Commercial Distribution

  • 00801741016219 ()
  • 10801741016216 ()
BRD400HK

  • Female stress urinary incontinence surgical mesh-sling, synthetic polymer

Ovarium Conception Trying To Conceive Lubricant 2oz/60mL - 00796494722879

Water-Based Personal Lubricant
CC Wellness LLC
72287
In Commercial Distribution

  • 10796494722876 ()
  • 00796494722879 ()


  • Sexual lubricant

Bard® Dual Connector to Plug, Monitor Cable - 00801741045882

Bard® Dual Connector to Plug, Monitor Cable
C. R. Bard, Inc.
153623M
In Commercial Distribution

  • 00801741045882 ()

  • Length: 12 Feet
153623M

  • Urine monitoring system

Denovo Dental Three Jaw Plier - To .036 Wire - 00810059291645

Denovo Dental Three Jaw Plier - To .036 Wire
Denovo Dental, Inc.
800-313
In Commercial Distribution

  • 00810059291645 ()


  • Orthodontic pliers

A.L.P.S.DRILL BIT (FOR UP TO 100MM LENGTH SCREWS) - 00887868024993

No Description
Biomet Orthopedics, LLC
2142-35-007
In Commercial Distribution

  • 00887868024993 ()

  • 2.5MM
214235007

  • Fluted surgical drill bit, single-use, non-sterile

DISP ECG LW, 5LEAD, SNAP TO MULTI LINK - 90840828100499

DISP ECG LW, 5LEAD, SNAP TO MULTI LINK
CURBELL MEDICAL PRODUCTS, INC.
DLW-05AD-40AM-0000
In Commercial Distribution

  • 90840828100505 ()
  • 90840828100499 ()
  • 90840828100512 ()
6759

  • Electrocardiographic electrode, single-use

DLW, 5LEAD, SNAP TO MULTI LINK,CHEST LD - 90840828100437

DLW, 5LEAD, SNAP TO MULTI LINK,CHEST LD
CURBELL MEDICAL PRODUCTS, INC.
DLW-05AM-40AM-0000
In Commercial Distribution

  • 90840828100444 ()
  • 90840828100437 ()
  • 90840828100451 ()
18030

  • Electrocardiographic electrode, single-use

DISP ECG LW, 5LEAD,PINCH TO MULTI LINK - 90840828100376

DISP ECG LW, 5LEAD,PINCH TO MULTI LINK
CURBELL MEDICAL PRODUCTS, INC.
DLW-05BD-40AM-0000
In Commercial Distribution

  • 90840828100383 ()
  • 90840828100376 ()
  • 90840828100390 ()
6762

  • Electrocardiographic electrode, single-use

DISP ECG LW, 5LEAD, PINCH TO MULTI LINK - 90840828100284

DISP ECG LW, 5LEAD, PINCH TO MULTI LINK
CURBELL MEDICAL PRODUCTS, INC.
DLW-05BM-40AM-0000
In Commercial Distribution

  • 90840828100291 ()
  • 90840828100284 ()
  • 90840828100307 ()
6766

  • Electrocardiographic electrode, single-use

DISP ECG LW, 6LEAD, SNAP TO MULTI LINK - 90840828100253

DISP ECG LW, 6LEAD, SNAP TO MULTI LINK
CURBELL MEDICAL PRODUCTS, INC.
DLW-06AD-40AM-0000
In Commercial Distribution

  • 90840828100260 ()
  • 90840828100253 ()
  • 90840828100277 ()
6767

  • Electrocardiographic electrode, single-use

DISP ECG LW, 6LEAD, PINCH TO MULTI LINK - 90840828100222

DISP ECG LW, 6LEAD, PINCH TO MULTI LINK
CURBELL MEDICAL PRODUCTS, INC.
DLW-06BD-40AM-0000
In Commercial Distribution

  • 90840828100239 ()
  • 90840828100222 ()
  • 90840828100246 ()
6768

  • Electrocardiographic electrode, single-use

Guarded Luer Connector Female Slip to Female Slip - B212574031

Guarded Luer Connector Female Slip to Female Slip, Pink, Sterile, Box of 50 individual blisters.
INTERNATIONAL MEDICAL INDUSTRIES INC.
57-403
In Commercial Distribution

  • B212574032 ()
  • B212574031 ()
57-403

  • Luer/Luer linear connector, single-use

Guarded Luer Connector Female Slip to Female Lock - B212574021

Guarded Luer Connector Female Slip to Female Lock, Blue, Sterile, Box of 50 individual blisters.
INTERNATIONAL MEDICAL INDUSTRIES INC.
57-402
In Commercial Distribution

  • B212574022 ()
  • B212574021 ()
57-402

  • Luer/Luer linear connector, single-use

Guide tube collector for up to 11 needles - 00816389028982

No Description
VARIAN MEDICAL SYSTEMS, INC.
GM11013950
In Commercial Distribution

  • 00816389028982 ()
GM11013950

  • Cervical/intrauterine brachytherapy system applicator, remote-afterloading

Guide tube collector for up to 7 needles - 00816389028975

No Description
VARIAN MEDICAL SYSTEMS, INC.
GM11013940
In Commercial Distribution

  • 00816389028975 ()
GM11013940

  • Cervical/intrauterine brachytherapy system applicator, remote-afterloading

MMI App for iOS - 00850037806010

iOS smartphone application for MODD1 Insulin Delivery System, software version v1.X
Modular Medical, Inc.
MODD1 Insulin Delivery System
In Commercial Distribution

  • 00850037806010 ()
MTL-103

  • Ambulatory insulin infusion pump software, patient-dosing

Nucleus® Smart App - 09321502065764

Hearing Implant Software for iOS Devices
COCHLEAR LIMITED
P1861019
In Commercial Distribution

  • 09321502065764 ()
P2006651

  • Audiometric/hearing device software

Nucleus® Smart App - 09321502062206

for iOS
COCHLEAR LIMITED
NSA-1 / v5
In Commercial Distribution

  • 09321502062206 ()
P1834114

  • Audiometric/hearing device software

Nucleus® Smart App - 09321502060486

for iOS
COCHLEAR LIMITED
NSA-1 / v4
In Commercial Distribution

  • 09321502060486 ()
P1787372

  • Audiometric/hearing device software

.decimal Astroid Dosimetry App - 00851147007076

The .decimal Astroid Dosimetry App device is used for planning and analysis of proton radiation therapy treatments.
DECIMAL, INC.
1.0
In Commercial Distribution

  • 00851147007076 ()


  • Radiation therapy software

DreamMapper App iOS (APAC) - 00606959049109

DreamMapper iOS APAC Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution

  • 00606959049109 ()
1127959

  • Self-care monitoring/reporting software

DreamMapper App iOS (APAC) - 00606959051355

DreamMapper iOS APAC Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051355 ()
1127959

  • Self-care monitoring/reporting software

DreamMapper App iOS (EMEA) - 00606959051348

DreamMapper iOS EU Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051348 ()
1128264

  • Self-care monitoring/reporting software

DreamMapper App iOS (APAC) - 00606959049956

DreamMapper iOS APAC Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049956 ()
1127959

  • Self-care monitoring/reporting software

DreamMapper App iOS (EMEA) - 00606959049949

DreamMapper iOS EU Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049949 ()
1128264

  • Self-care monitoring/reporting software

DreamMapper App iOS (EMEA) - 00606959049093

DreamMapper iOS EU Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution

  • 00606959049093 ()
1128264

  • Self-care monitoring/reporting software

Eko Mobile App iOS - 00863609000334

iOS mobile device software for use with Eko products.
Eko Devices, Inc.
3.1.1
In Commercial Distribution

  • 00863609000334 ()


  • Medical equipment clinical data interfacing software

nfant® Mobile App - 00861410000246

No Description
NFANT LABS LLC
1
In Commercial Distribution

  • 00861410000246 ()
NA4

  • Biofeedback system application software

OPSB Sensor Mobile App - 00860013109813

No Description
Boston Brace International, Inc.
SENSOR-MA-V1
In Commercial Distribution

  • 00860013109813 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

Guardian™ Connect App - 00763000381103

SFTWR CSS7200 GRDN MBL IOS V 4.1.0
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000381103 ()


  • Patient health record information system application software

CONTOUR® DIABETES APP - 00301933537015

Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3537
In Commercial Distribution

  • 00301933537015 ()
85498754

  • Self-care monitoring/reporting software
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