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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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T22 Self-Retaining Driver with Dedicated Handle
SPINECRAFT, LLC
6300-22-3
In Commercial Distribution

  • 00193082076749 ()
6300-22-3

  • General internal orthopaedic fixation system implantation kit
T22 Hexalobe Driver
SPINECRAFT, LLC
6300-22-M
In Commercial Distribution

  • 00193082076466 ()
6300-22-M

  • General internal orthopaedic fixation system implantation kit
Rainer Mallet, large Ø31,8mm, 340g, 247mm
RZ-Medizintechnik GmbH
259-149-002
In Commercial Distribution

  • 04049197495721 ()
259-149-002

  • Surgical mallet
Pin Driver
GS Medical Co., Ltd.
GS136-2450
In Commercial Distribution

  • 08806162109450 ()
GS136-2450

  • Surgical screwdriver, reusable
No Description
DENTOS Inc.
NLHD-S
In Commercial Distribution

  • 08806145484086 ()


  • Surgical screwdriver, reusable
No Description
DENTOS Inc.
NLHD-S+ST-L
In Commercial Distribution

  • 08806145440167 ()


  • Surgical screwdriver, reusable
The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor ismanufactured from biodegradable materials (PLGA copolymer and beta-TCP). A nonabsorbable UHMWPE suture is inserted into the anchor. The anchor is implanted using a provided driver. B,N,BN type(Knotted suture anchors) are ‘screw-in’ anchors used alone or in combination with Kc,KcN type(Knotless suture anchors) for soft-tissue repair. Kc,KcN type(Knotless suture anchor) are used for a soft-tissue repair in combination with the B,N,BN type. SL type ‘push-in’ anchors that are ideal for soft-tissue repair in narrow or deep areas. S type are ‘push-in’ anchors that are ideal for soft-tissue repair in the foot, ankle, hand and wrist The Fixone Biocomposite Anchor consists of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The Fixone Biocomposite Anchor is intended to provide secure reattachment of the soft tissue to bone. Devices are provided sterile. Single use only.
AJU PHARM. CO., LTD.
SAB-30002e
In Commercial Distribution

  • 08806109701068 ()


  • Tendon/ligament bone anchor, bioabsorbable
No Description
CG MedTech Co.,Ltd.
NPS0040
In Commercial Distribution

  • 08800308498149 ()


  • Surgical screwdriver, reusable
No Description
CG MedTech Co.,Ltd.
NP0600
In Commercial Distribution

  • 08800308498095 ()


  • Surgical screwdriver, reusable
No Description
CG MedTech Co.,Ltd.
NP0180
In Commercial Distribution

  • 08800308498064 ()


  • Surgical screwdriver, reusable
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