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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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IMPLANTOLOGY TOOLS - 07290113355989

One piece Clip mount
DENTIN IMPLANTS TECHNOLOGIES LTD
DCM-0020
In Commercial Distribution

  • 07290113355989 ()


  • Surgical screwdriver, reusable

IMPLANTOLOGY TOOLS - 07290113355972

Implant Clip Mount
DENTIN IMPLANTS TECHNOLOGIES LTD
DCM-0010
In Commercial Distribution

  • 07290113355972 ()


  • Surgical screwdriver, reusable

IMPLANTOLOGY TOOLS - 07290113356306

Drill Extension
DENTIN IMPLANTS TECHNOLOGIES LTD
DDR-5001
In Commercial Distribution

  • 07290113356306 ()


  • Dental drill bit extension

IMPLANTOLOGY TOOLS - 07290113356283

Motor mount 2.42 hex L 20mm
DENTIN IMPLANTS TECHNOLOGIES LTD
DCT-0252
In Commercial Distribution

  • 07290113356283 ()


  • Surgical screwdriver, reusable

IMPLANTOLOGY TOOLS - 07290113356269

Torque Ratchet
DENTIN IMPLANTS TECHNOLOGIES LTD
DCT-0810
In Commercial Distribution

  • 07290113356269 ()


  • Dental torque wrench

IMPLANTOLOGY TOOLS - 07290113356252

Ratchet
DENTIN IMPLANTS TECHNOLOGIES LTD
DCT-0800
In Commercial Distribution

  • 07290113356252 ()


  • Dental torque wrench

IMPLANTOLOGY TOOLS - 07290113356184

Parallel pin Long
DENTIN IMPLANTS TECHNOLOGIES LTD
DCT-L400
In Commercial Distribution

  • 07290113356184 ()


  • Dental implant/prosthesis surgical procedure kit

IMPLANTOLOGY TOOLS - 07290113356177

Parallel pin Short
DENTIN IMPLANTS TECHNOLOGIES LTD
DCT-0400
In Commercial Distribution

  • 07290113356177 ()


  • Dental implant/prosthesis surgical procedure kit

IMPLANTOLOGY TOOLS - 07290113356160

Hand Hex driver 1.25 mm L 15 mm
DENTIN IMPLANTS TECHNOLOGIES LTD
DCT-0315
In Commercial Distribution

  • 07290113356160 ()


  • Surgical screwdriver, reusable

IMPLANTOLOGY TOOLS - 07290113356153

Hand Hex driver 1.25 mm L 10 mm
DENTIN IMPLANTS TECHNOLOGIES LTD
DCT-0310
In Commercial Distribution

  • 07290113356153 ()


  • Surgical screwdriver, reusable

IMPLANTOLOGY TOOLS - 07290113356146

Hand Hex driver 1.25 mm L 7 mm
DENTIN IMPLANTS TECHNOLOGIES LTD
DCT-0307
In Commercial Distribution

  • 07290113356146 ()


  • Surgical screwdriver, reusable

IMPLANTOLOGY TOOLS - 07290113356139

Hex driver 2.4 mm L 15 mm
DENTIN IMPLANTS TECHNOLOGIES LTD
DCT-0215
In Commercial Distribution

  • 07290113356139 ()


  • Surgical screwdriver, reusable

IMPLANTOLOGY TOOLS - 07290113356122

Hex driver 2.4 mm L 10 mm
DENTIN IMPLANTS TECHNOLOGIES LTD
DCT-0210
In Commercial Distribution

  • 07290113356122 ()


  • Surgical screwdriver, reusable

IMPLANTOLOGY TOOLS - 07290113356115

Hex driver 2.4 mm L 7 mm
DENTIN IMPLANTS TECHNOLOGIES LTD
DCT-0207
In Commercial Distribution

  • 07290113356115 ()


  • Surgical screwdriver, reusable

IMPLANTOLOGY TOOLS - 07290113356108

Hex driver 1.25 mm L 15 mm
DENTIN IMPLANTS TECHNOLOGIES LTD
DCT-0115
In Commercial Distribution

  • 07290113356108 ()


  • Surgical screwdriver, reusable

IMPLANTOLOGY TOOLS - 07290113356092

Hex driver 1.25 mm L 10 mm
DENTIN IMPLANTS TECHNOLOGIES LTD
DCT-0110
In Commercial Distribution

  • 07290113356092 ()


  • Surgical screwdriver, reusable

IMPLANTOLOGY TOOLS - 07290113356085

Hex driver 1.25 mm L 7 mm
DENTIN IMPLANTS TECHNOLOGIES LTD
DCT-0107
In Commercial Distribution

  • 07290113356085 ()


  • Surgical screwdriver, reusable

IMPLANTOLOGY TOOLS - 07290113356009

One piece Tool Key Adaptor
DENTIN IMPLANTS TECHNOLOGIES LTD
DCT-0055
In Commercial Distribution

  • 07290113356009 ()


  • Surgical screwdriver, reusable

IMPLANTOLOGY TOOLS - 07290113354111

Orientation Lead Holder
DENTIN IMPLANTS TECHNOLOGIES LTD
OLH-0035
In Commercial Distribution

  • 07290113354111 ()


  • Surgical screwdriver, reusable

IMPLANTOLOGY TOOLS - 07290113354104

Orientation Lead Clip Holder Spanner Parts
DENTIN IMPLANTS TECHNOLOGIES LTD
OLCH-2200
In Commercial Distribution

  • 07290113354104 ()


  • Surgical screwdriver, reusable

IMPLANTOLOGY TOOLS - 07290113353923

Hex Key 13mm Length
DENTIN IMPLANTS TECHNOLOGIES LTD
HK-12713
In Commercial Distribution

  • 07290113353923 ()


  • Surgical screwdriver, reusable

MR8 Tools - 00763000714550

TOOL MR8-14TD3030 MR8 TWIST DRL 3MMX30MM
MEDTRONIC POWERED SURGICAL SOLUTIONS
MR8-14TD3030
In Commercial Distribution

  • 00763000714550 ()


  • Orthopaedic bur, single-use

MR8 Tools - 00763000714543

TOOL MR8-12BA50DC 12CM BALL 5MM DC
MEDTRONIC POWERED SURGICAL SOLUTIONS
MR8-12BA50DC
In Commercial Distribution

  • 00763000714543 ()


  • Orthopaedic bur, single-use

MR8 Tools - 00763000714475

TOOL MR8-10TA16 10CM TAPER 1.6MM
MEDTRONIC POWERED SURGICAL SOLUTIONS
MR8-10TA16
In Commercial Distribution

  • 00763000714475 ()


  • Orthopaedic bur, single-use

MR8 Tools - 00763000447298

TOOL MR8-10MH30SH 10CM MATCH 3MM SHORT
MEDTRONIC POWERED SURGICAL SOLUTIONS
MR8-10MH30SH
In Commercial Distribution

  • 00763000447298 ()


  • Orthopaedic bur, single-use

MR8 Tools - 00763000447281

TOOL MR8-12MH30SH 12CM MATCH 3MM SHORT
MEDTRONIC POWERED SURGICAL SOLUTIONS
MR8-12MH30SH
In Commercial Distribution

  • 00763000447281 ()


  • Orthopaedic bur, single-use

MR8 Tools - 00763000585211

TOOL MR8-7TA13 MR8 7CM TAPER 1.3MM
MEDTRONIC POWERED SURGICAL SOLUTIONS
MR8-7TA13
In Commercial Distribution

  • 00763000585211 ()


  • Orthopaedic bur, single-use

MR8 Tools - 00763000290283

TOOL MR8-9AC75M MR8 9CM ACORN 7.5MM 2FLT
MEDTRONIC POWERED SURGICAL SOLUTIONS
MR8-9AC75M
In Commercial Distribution

  • 00763000290283 ()


  • Orthopaedic bur, single-use

ACE - 00614950028344

Set of 6 Mucosa Punches with Tools
ACE SURGICAL SUPPLY CO., INC.
9200020
In Commercial Distribution

  • 00614950028344 ()
9200020

  • Skin-coring punch, reusable

KYPHON ELEMENT™ Balloon Kyphoplasty System - 00643169582231

BONE ACCESS TOOLS T25R VALUE BONE ACCESS
MEDTRONIC SOFAMOR DANEK, INC.
T25R
Not in Commercial Distribution

  • 00643169582231 ()


  • Bone access cannula

Standard Surgical Kit - 10841307125846

Drills & Tools (Qty 23) Tray & Pan (Qty1)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
CSSK
In Commercial Distribution

  • 10841307125846 ()
CSSK

  • Device sterilization/disinfection container, reusable

InterActive® Surgical Kit - 10841307125839

Drills & Tools (Qty 19) Tray & Pan (Qty1)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
CISK
In Commercial Distribution

  • 10841307125839 ()
CISK

  • Device sterilization/disinfection container, reusable

Standard Surgical Kit - Simply Iconic™ - 10841307127765

"Drills & Tools (Qty 36) Tray (Qty 1)"
IMPLANT DIRECT SYBRON MANUFACTURING LLC
CSSK-SI
In Commercial Distribution

  • 10841307127765 ()
CSSK-SI

  • Device sterilization/disinfection container, reusable

Standard Surgical Kit -Legacy™ - 10841307127758

"Drills & Tools (Qty 40) Tray (Qty 1)"
IMPLANT DIRECT SYBRON MANUFACTURING LLC
CSSK-L
In Commercial Distribution

  • 10841307127758 ()
CSSK-L

  • Device sterilization/disinfection container, reusable

InterActive®Surgical Kit Mini - 10841307125792

Drills & Tools (Qty 11) Tray & Pan (Qty1)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
CISKM
In Commercial Distribution

  • 10841307125792 ()
CISKM

  • Device sterilization/disinfection container, reusable

Height limiting tools vks-oc - EBRE860001300

Height limiting tools vks-oc 2.2 1 Piece
bredent GmbH & Co. KG
86000130
In Commercial Distribution

  • EBRE860001309 ()
  • EBRE860001300 ()
86000130

  • Bar dental precision attachment

Height limiting tools vks-oc - EBRE860001200

Height limiting tools vks-oc 1.7 1 Piece
bredent GmbH & Co. KG
86000120
In Commercial Distribution

  • EBRE860001209 ()
  • EBRE860001200 ()
86000120

  • Bar dental precision attachment

DIRECTguide™ Guided Surgery Kit - Conical - 10841307131038

"Drills & Tools (Qty 48) Tray (Qty 1)"
IMPLANT DIRECT SYBRON MANUFACTURING LLC
GSK-C
In Commercial Distribution

  • 10841307131038 ()
GSK-C

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

DIRECTguide™ Guided Surgery Kit - Legacy - 10841307131021

"Drills & Tools (Qty 51) Tray (Qty 1)"
IMPLANT DIRECT SYBRON MANUFACTURING LLC
GSK-L
In Commercial Distribution

  • 10841307131021 ()
GSK-L

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

UNISYNCASE3 - 00840286839594

UNISYN Case 3 Disassembly and Removal Tools
Shalby Advanced Technologies, Inc.
UNISYNCASE3
In Commercial Distribution

  • 00840286839594 ()
UNISYNCASE3

  • Surgical instrument/implant rack

NA - 10886982006479

T-HANDLE WITH QC FOR IM REDUCTION TOOLS
Synthes GmbH
SD360.249
In Commercial Distribution

  • H679SD3602490 ()
  • 10886982006479 ()
SD360249

  • Surgical instrument handle, non-torque-limiting

MIS - 07290109013602

MGUIDE tools kit for coni. con. implant
MIS Implants Technologies Ltd.
MG-KT04
In Commercial Distribution

  • 07290109013602 ()
MG-KT04

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

MIS - 07290109013138

Guided Tools extender for 4.70 mm Hex.
MIS Implants Technologies Ltd.
MG1-TE480
In Commercial Distribution

  • 07290109013138 ()
MG1-TE480

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

Kyphon ELEMENT Osteo Introducer - 00763000026721

BONE ACCESS TOOLS T25R VALUE BONE ACCESS
MEDTRONIC SOFAMOR DANEK, INC.
T25R
In Commercial Distribution

  • 00763000026721 ()


  • Bone access cannula

ICU Medical MedNet - 10887787009139

Mednet Software
ICU MEDICAL, INC.
6.31.01
In Commercial Distribution

  • 10887787009139 ()
160379202

  • Infusion pump medication-dosage application software

ICU Medical MedNet - 10887787009115

Mednet Software
ICU MEDICAL FLEET SERVICES, LLC
6.30.01
In Commercial Distribution

  • 10887787009115 ()
160379201

  • Infusion pump medication-dosage application software

MedNet - 10887787001751

Metnet Software
HOSPIRA, INC.
6.20.01
In Commercial Distribution

  • 10887787001751 ()
160376404

  • Infusion pump medication-dosage application software

EncoreBasic - 00606959049284

EncoreBasic Software
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049284 ()
1068689

  • Medical equipment clinical data interfacing software

EncoreBasic - 00606959052406

EncoreBasic Software
Respironics, Inc.
2.12
In Commercial Distribution

  • 00606959052406 ()
1068689

  • Medical equipment clinical data interfacing software

EncoreBasic - 00606959046962

EncoreBasic Software
Respironics, Inc.
EncoreBasic Software - 2
In Commercial Distribution

  • 00606959046962 ()
1068689

  • Medical equipment clinical data interfacing software
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