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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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4CIS® INSTRUMENT SYSTEM - 08806373589935

4CIS® Chiron Rod Rocker 6.0 type
ALPHANOX CO.,LTD.
4901-8057
In Commercial Distribution

  • 08806373589935 ()
4901-8057

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373589928

4CIS® Chiron Rod Rocker 5.5 type
ALPHANOX CO.,LTD.
4901-8012
In Commercial Distribution

  • 08806373589928 ()
4901-8012

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373589904

4CIS® Chiron Rod Holder A type
ALPHANOX CO.,LTD.
4901-8032
In Commercial Distribution

  • 08806373589904 ()
4901-8032

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373589898

4CIS® In-situ Rod Bender, Left
ALPHANOX CO.,LTD.
4901-8010
In Commercial Distribution

  • 08806373589898 ()
4901-8010

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373589881

4CIS® In-situ Rod Bender, Right
ALPHANOX CO.,LTD.
4901-8011
In Commercial Distribution

  • 08806373589881 ()
4901-8011

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373589874

4CIS® French Rod Bender
ALPHANOX CO.,LTD.
4901-8051
In Commercial Distribution

  • 08806373589874 ()
4901-8051

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373589867

4CIS® Ratcheting I-Handle
ALPHANOX CO.,LTD.
4901-7050
In Commercial Distribution

  • 08806373589867 ()
4901-7050

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373589850

4CIS® Ratcheting T-Handle
ALPHANOX CO.,LTD.
4901-8050
In Commercial Distribution

  • 08806373589850 ()
4901-8050

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373589843

4CIS® Screw Head Positioner
ALPHANOX CO.,LTD.
4901-8031
In Commercial Distribution

  • 08806373589843 ()
4901-8031

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373589836

4CIS® Chiron Screw Driver
ALPHANOX CO.,LTD.
4901-8009
In Commercial Distribution

  • 08806373589836 ()
4901-8009

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373589829

4CIS® Chiron Tap Ø7.5
ALPHANOX CO.,LTD.
4901-8008
In Commercial Distribution

  • 08806373589829 ()
4901-8008

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373589812

4CIS® Chiron Tap Ø6.5
ALPHANOX CO.,LTD.
4901-8007
In Commercial Distribution

  • 08806373589812 ()
4901-8007

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373589805

4CIS® Chiron Tap Ø5.5
ALPHANOX CO.,LTD.
4901-8006
In Commercial Distribution

  • 08806373589805 ()
4901-8006

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373589799

4CIS® Chiron Tap Ø4.5
ALPHANOX CO.,LTD.
4901-8005
In Commercial Distribution

  • 08806373589799 ()
4901-8005

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373589782

4CIS® Sounder, Angled
ALPHANOX CO.,LTD.
4901-8030
In Commercial Distribution

  • 08806373589782 ()
4901-8030

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373589775

4CIS® Sounder, Straight
ALPHANOX CO.,LTD.
4901-8029
In Commercial Distribution

  • 08806373589775 ()
4901-8029

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373589768

4CIS® Sounder, Angled
ALPHANOX CO.,LTD.
4901-8004
In Commercial Distribution

  • 08806373589768 ()
4901-8004

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373589751

4CIS® Sounder, Straight
ALPHANOX CO.,LTD.
4901-8003
In Commercial Distribution

  • 08806373589751 ()
4901-8003

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373589744

4CIS® Pedicle Probe, Curved
ALPHANOX CO.,LTD.
4901-8002
In Commercial Distribution

  • 08806373589744 ()
4901-8002

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373589737

4CIS® Pedicle Probe, Straight
ALPHANOX CO.,LTD.
4901-8001
In Commercial Distribution

  • 08806373589737 ()
4901-8001

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373589720

4CIS® Awl
ALPHANOX CO.,LTD.
4901-8028
In Commercial Distribution

  • 08806373589720 ()
4901-8028

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373586866

EMG Sleeve
ALPHANOX CO.,LTD.
9807-0032
In Commercial Distribution

  • 08806373586866 ()
9807-0032

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373586859

DILATOR3
ALPHANOX CO.,LTD.
9807-0031
In Commercial Distribution

  • 08806373586859 ()
9807-0031

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373586842

Apollon Guide Pin
ALPHANOX CO.,LTD.
4901-3037
In Commercial Distribution

  • 08806373586842 ()
4901-3037

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373586811

Compressor
ALPHANOX CO.,LTD.
4901-0018
In Commercial Distribution

  • 08806373586811 ()
4901-0018

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373586798

Rod Pusher
ALPHANOX CO.,LTD.
4901-0016
In Commercial Distribution

  • 08806373586798 ()
4901-0016

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373586750

Guide Pins Triangle
ALPHANOX CO.,LTD.
4901-0005
In Commercial Distribution

  • 08806373586750 ()
4901-0005

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373586743

Tester
ALPHANOX CO.,LTD.
4901-0004
In Commercial Distribution

  • 08806373586743 ()
4901-0004

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373586736

Pedicle Probe for 6.5 Screw
ALPHANOX CO.,LTD.
4901-0003
In Commercial Distribution

  • 08806373586736 ()
4901-0003

  • External spinal fixation system

PICASSO II - 00841732124653

Drill, Cannulated, 1/4" Square QC, D7.0mm
CTL Medical Corporation
019.7044
In Commercial Distribution

  • 00841732124653 ()


  • Surgical screwdriver, reusable

PICASSO II - 00841732124646

Drill, Cannulated, 1/4" Square QC, D6.0mm
CTL Medical Corporation
019.7043
In Commercial Distribution

  • 00841732124646 ()


  • Surgical screwdriver, reusable

RAPHAEL - 00841732124189

Square Driver
CTL Medical Corporation
115.7069
In Commercial Distribution

  • 00841732124189 ()


  • Internal spinal fixation procedure kit, reusable

PICASSO II - 00841732123335

Hex Driver MIS, 1/4" Square QC, 4.0, Ratcheting, Long
CTL Medical Corporation
019.7059
In Commercial Distribution

  • 00841732123335 ()


  • Internal spinal fixation procedure kit, reusable

RAPHAEL - 00841732122512

C-T Compression Lever Hex Driver Shaft, 5.0 (Note: 1/4" Sq.QC, Self-Retention)
CTL Medical Corporation
015.7078
In Commercial Distribution

  • 00841732122512 ()


  • Internal spinal fixation procedure kit, reusable

Navigation - 00841732130012

Navigation Driver, HEX 4.0, LX, MIS
CTL Medical Corporation
109.7550
In Commercial Distribution

  • 00841732130012 ()


  • General internal orthopaedic fixation system implantation kit

TAURUS - 00841732129658

HEXALOBE DRIVER, TYPE, CANNULATED,T25
CTL Medical Corporation
059.7100
In Commercial Distribution

  • 00841732129658 ()


  • Internal spinal fixation procedure kit, reusable

CASSATT - 00841732129634

T25 HEXALOBULAR DRIVER
CTL Medical Corporation
133.7540
In Commercial Distribution

  • 00841732129634 ()


  • General internal orthopaedic fixation system implantation kit

TAURUS - 00841732129535

Final Tightening Driver, T30, 7mm, HEX
CTL Medical Corporation
059.7251
In Commercial Distribution

  • 00841732129535 ()


  • Internal spinal fixation procedure kit, reusable

PICASSO II - 00841732123328

Hex Driver MIS, 1/4" Square QC, 4.0, Ratcheting, Short
CTL Medical Corporation
019.7058
In Commercial Distribution

  • 00841732123328 ()


  • Internal spinal fixation procedure kit, reusable

BENCO - 00366975019035

MALLET MEAD 7.5" SOFT
BENCO DENTAL SUPPLY CO.
1695-454
In Commercial Distribution

  • 00366975019035 ()

  • Length: 7.5 Inch


  • Surgical mallet

BENCO - 00366975019028

MALLET #49 7.5" LEAD FILLED
BENCO DENTAL SUPPLY CO.
1695-445
In Commercial Distribution

  • 00366975019028 ()

  • Length: 7.5 Inch


  • Surgical mallet

Leforte System Bone Plate / GBR System Bone Plate - 08809282819049

No Description
Jeil Medical Corporation
12-GM-002-01
In Commercial Distribution

  • 08809282819049 ()


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

Surgical Instrument - 08809282816567

No Description
Jeil Medical Corporation
113-HF-103
In Commercial Distribution

  • 08809282816567 ()


  • Surgical screwdriver, reusable

Surgical Instrument - 08809282816154

No Description
Jeil Medical Corporation
113-GD-221
In Commercial Distribution

  • 08809282816154 ()


  • Surgical screwdriver, reusable

Surgical Instrument - 08809282818752

No Description
Jeil Medical Corporation
113-HF-607
In Commercial Distribution

  • 08809282818752 ()


  • Surgical screwdriver, reusable

Leforte System Bone Plate - 08809282818684

No Description
Jeil Medical Corporation
20-CV-106-F
In Commercial Distribution

  • 08809282818684 ()


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

Surgical Instrument - 08809282818028

No Description
Jeil Medical Corporation
113-MD-221
In Commercial Distribution

  • 08809282818028 ()


  • Surgical screwdriver, reusable

Surgical Instrument - 08809282816864

No Description
Jeil Medical Corporation
111-077
In Commercial Distribution

  • 08809282816864 ()


  • Surgical screwdriver, reusable

Surgical Instrument - 08809282816840

No Description
Jeil Medical Corporation
113-LS-201
In Commercial Distribution

  • 08809282816840 ()


  • Surgical screwdriver, reusable

Surgical Instrument - 08809282815775

No Description
Jeil Medical Corporation
113-HF-606
In Commercial Distribution

  • 08809282815775 ()


  • Surgical screwdriver, reusable
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