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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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Cosmolock Pedicle Screw System - B07311K0130190

T-Handle, Head Persuader, 5.5mm
Kalitec Direct LLC
11-K01-3019
In Commercial Distribution

  • B07311K0130190 ()


  • Spinal rod bending system

CosmoLock Pedicle Screw System - B07311K0130140

Sagittal Bender, Right
Kalitec Direct LLC
11-K01-3014
In Commercial Distribution

  • B07311K0130140 ()


  • Spinal rod bending system

CosmoLock Pedicle Screw System - B07311K0130130

Sagittal Bender, Left
Kalitec Direct LLC
11-K01-3013
In Commercial Distribution

  • B07311K0130130 ()


  • Spinal rod bending system

Black Diamond Pedicle Screw System - B06210101550

TUBE ROD BENDER, BLK DIAMOND
Osseus Fusion Systems, LLC
1010-1550
In Commercial Distribution

  • B06210101550 ()
1010-1550

  • Spinal rod bending system

Black Diamond Pedicle Screw System - B06210101400

IN-SITU BENDERS, BLK DIAMOND
Osseus Fusion Systems, LLC
1010-1400
In Commercial Distribution

  • B06210101400 ()
1010-1400

  • Spinal rod bending system

ArcScan Insight 100 - B017ED102

No Description
ARCSCAN, INC.
EyeSeal Disposable
In Commercial Distribution

  • B017ED113 ()
  • B017ED102 ()
ED1

  • Ophthalmic ultrasound imaging system

ArcScan Insight 100 - B017AS100

No Description
ARCSCAN, INC.
AS100
In Commercial Distribution

  • B017AS100 ()
AS100-120

  • Ophthalmic ultrasound imaging system

NIDO Pedicle Screw System - B07315K0430210

Sagittal Bender, Double Ended Right
Kalitec Direct LLC
15-K04-3021
In Commercial Distribution

  • B07315K0430210 ()
15-K04-3021

  • Spinal rod bending system

NIDO Pedicle Screw System - B07315K0430200

Sagittal Bender, Double Ended Left
Kalitec Direct LLC
15-K04-3020
In Commercial Distribution

  • B07315K0430200 ()
15-K04-3020

  • Spinal rod bending system

NIDO Pedicle Screw System - B07315K0122100

T-Handle, Head Persuader
Kalitec Direct LLC
15-K01-2210
In Commercial Distribution

  • B07315K0122100 ()
15-K01-2210

  • Spinal rod bending system
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