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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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SleepImage - B315SLEEPIMAGECOM0

Web based software
MYCARDIO LLC
8
Not in Commercial Distribution

  • B315SLEEPIMAGECOM0 ()


  • Multiple physiological signal amplifier

UbiqVue - B353UA2251C1

Holter Web Portal
Lifesignals, Inc.
UA2251-C
In Commercial Distribution

  • B353UA2251C1 ()


  • Wireless patient monitor/sensor reporting software, professional-only

Arthrex® - 00888867264953

ArthrexVIP Web Portal
ARTHREX, INC.
5566VIP
In Commercial Distribution

  • 00888867264953 ()
5566VIP

  • Orthopaedic/craniofacial implantation planning software

CARDINAL HEALTH - 10888439347753

KIT, COMMON SPIRO
Cardinal Health 200, LLC
SPK692448E
In Commercial Distribution

  • 50888439347751 ()
  • 10888439347753 ()
SPK692448E

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

CARDINAL HEALTH - 10888439633009

KIT, COMMON SPIRO
Cardinal Health 200, LLC
SPK692448G
In Commercial Distribution

  • 50888439633007 ()
  • 10888439633009 ()
SPK692448G

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

Implant Carrier - 08809854020002

Common Narrow/ Hex2.3
Megagen Implant Co. Ltd
ICNH2303
In Commercial Distribution

  • 08809854020002 ()
ICNH2303

  • Surgical screwdriver, reusable

Kit Case - 08809822764143

Common Middle kit
Megagen Implant Co. Ltd
R2SK2000
In Commercial Distribution

  • 08809822764143 ()
R2SK2000

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable

R2 Sinus Kit - 08809728990509

Common Middle kit
Megagen Implant Co. Ltd
R2SK3001
In Commercial Distribution

  • 08809728990509 ()
R2SK3001

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Bone Profiler - 08809708754763

Common Ø5/ Long
Megagen Implant Co. Ltd
TANBPL50
In Commercial Distribution

  • 08809708754763 ()
TANBPL50

  • Fixture/appliance dental drill bit, reusable

Bone Profiler - 08809708754756

Common Ø4/ Long
Megagen Implant Co. Ltd
TANBPL40
In Commercial Distribution

  • 08809708754756 ()
TANBPL40

  • Fixture/appliance dental drill bit, reusable

Bone Profiler - 08809708754770

Common Ø6/ Short
Megagen Implant Co. Ltd
TANBPS60
In Commercial Distribution

  • 08809708754770 ()
TANBPS60

  • Fixture/appliance dental drill bit, reusable

Instrument - 05060296236427

Common Lid - Transparent
Stanmore Implants Worldwide Ltd
LID-SIW
Not in Commercial Distribution

  • 05060296236427 ()
LID

  • Instrument tray, reusable

Millennium - 00190776091378

Gregory Common Femoral
Avalign Technologies, Inc.
17-344990
In Commercial Distribution

  • 00190776091378 ()


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

CARDINAL HEALTH - 10887488859729

KIT, COMMON DIABETES
Cardinal Health 200, LLC
SP1692448A
In Commercial Distribution

  • 50887488859727 ()
  • 10887488859729 ()
SP1692448A

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

Navigated Instruments - 00195860027042

COMMON TRAY LID
Evolution Spine LLC
999-A023
In Commercial Distribution

  • 00195860027042 ()
999-A023

  • Instrument tray, reusable

APEX Knee System - 00841690189015

COMMON PAN INSTRUMENTS
Omni Life Science, Inc.
KS-99168
In Commercial Distribution

  • 00841690189015 ()
KS-99168

  • Instrument tray, reusable

APEX Knee System - 00841690188964

COMMON PAN INSTRUMENTS
Omni Life Science, Inc.
KS-99173
In Commercial Distribution

  • 00841690188964 ()
KS-99173

  • Instrument tray, reusable

APEX Knee System - 00841690188827

COMMON PAN INSTRUMENTS
Omni Life Science, Inc.
KS-99261
In Commercial Distribution

  • 00841690188827 ()
KS-99261

  • Instrument tray, reusable

Plastice Impression Tray - 08806388211777

Common Small Mandible
Megagen Implant Co. Ltd
CONTS002
In Commercial Distribution

  • 08806388211777 ()
CONTS002

  • Dental implant system

Plastice Impression Tray - 08806388211760

Common Small Maxilla
Megagen Implant Co. Ltd
CONTS001
In Commercial Distribution

  • 08806388211760 ()
CONTS001

  • Dental implant system

Plastice Impression Tray - 08806388211753

Common Medium Down
Megagen Implant Co. Ltd
CONTM002
In Commercial Distribution

  • 08806388211753 ()
CONTM002

  • Dental implant system

Plastice Impression Tray - 08806388211746

Common Medium Up
Megagen Implant Co. Ltd
CONTM001
In Commercial Distribution

  • 08806388211746 ()
CONTM001

  • Dental implant system

Plastice Impression Tray - 08806388211739

Common Large Down
Megagen Implant Co. Ltd
CONTL002
In Commercial Distribution

  • 08806388211739 ()
CONTL002

  • Dental implant system

Plastice Impression Tray - 08806388211722

Common Large 상악용
Megagen Implant Co. Ltd
CONTL001
In Commercial Distribution

  • 08806388211722 ()
CONTL001

  • Dental implant system

ASBE Trephine - 08806388211319

Common Ø5/ Ø6
Megagen Implant Co. Ltd
ASBESS56
In Commercial Distribution

  • 08806388211319 ()
ASBESS56

  • Fixture/appliance dental drill bit, reusable

ASBE Trephine - 08806388211302

Common Ø4/ Ø5
Megagen Implant Co. Ltd
ASBESS45
In Commercial Distribution

  • 08806388211302 ()
ASBESS45

  • Fixture/appliance dental drill bit, reusable

ASBE Trephine - 08806388211296

Common Ø3.5/ Ø4
Megagen Implant Co. Ltd
ASBESS34
In Commercial Distribution

  • 08806388211296 ()
ASBESS34

  • Fixture/appliance dental drill bit, reusable

Ratchet Connector - 08806388206445

Common Hex1.7/ Regular
Megagen Implant Co. Ltd
AGRCR17
In Commercial Distribution

  • 08806388206445 ()
AGRCR17

  • Surgical screwdriver, reusable

Handpiece Connector - 08806388206377

Common Hex1.7/ Regular
Megagen Implant Co. Ltd
AGHCR17
In Commercial Distribution

  • 08806388206377 ()
AGHCR17

  • Surgical screwdriver, reusable

Handpiece Adapter - 08806388206360

Common Squared 4
Megagen Implant Co. Ltd
AGHA
In Commercial Distribution

  • 08806388206360 ()
AGHA

  • Surgical screwdriver, reusable

CARDINAL HEALTH - 10888439537833

KIT, COMMON SPIRO
Cardinal Health 200, LLC
SPK692448F
In Commercial Distribution

  • 50888439537831 ()
  • 10888439537833 ()
SPK692448F

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

Lab Analog - 08806388244072

Common Ø4.8/ M1.4
Megagen Implant Co. Ltd
MUALA
In Commercial Distribution

  • 08806388244072 ()
MUALA

  • Dental implant suprastructure, permanent, preformed

Torque Wrench - 08806388240487

Common L=127
Megagen Implant Co. Ltd
TW500
In Commercial Distribution

  • 08806388240487 ()
TW500

  • Surgical screwdriver, reusable

Coronal Drill - 08806388240289

Common Ø6/ Ø6.9
Megagen Implant Co. Ltd
TTSCD70
In Commercial Distribution

  • 08806388240289 ()
TTSCD70

  • Fixture/appliance dental drill bit, reusable

Coronal Drill - 08806388240272

Common Ø5/ Ø5.9
Megagen Implant Co. Ltd
TTSCD60
In Commercial Distribution

  • 08806388240272 ()
TTSCD60

  • Fixture/appliance dental drill bit, reusable

Coronal Drill - 08806388240265

Common Ø4.5/ Ø5.4
Megagen Implant Co. Ltd
TTSCD55
In Commercial Distribution

  • 08806388240265 ()
TTSCD55

  • Fixture/appliance dental drill bit, reusable

Coronal Drill - 08806388240258

Common Ø3.8/ Ø4.7
Megagen Implant Co. Ltd
TTSCD48
In Commercial Distribution

  • 08806388240258 ()
TTSCD48

  • Fixture/appliance dental drill bit, reusable

Torque Wrench Adapter - 08806388240227

Common Ratchet Type
Megagen Implant Co. Ltd
TTAR100
In Commercial Distribution

  • 08806388240227 ()
TTAR100

  • Surgical screwdriver, reusable

Torque Wrench Adapter - 08806388240210

Common Handpiece Type
Megagen Implant Co. Ltd
TTAI100
In Commercial Distribution

  • 08806388240210 ()
TTAI100

  • Surgical screwdriver, reusable

Torque Driver - 08806388240203

Common Hex 1.2
Megagen Implant Co. Ltd
TTAD120S
In Commercial Distribution

  • 08806388240203 ()
TTAD120S

  • Surgical screwdriver, reusable
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