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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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Teflon Inserts for Mallet for assi.atk38419 Mallet only
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
ASSI.ATK33326
In Commercial Distribution

  • 00841645130819 ()


  • Surgical mallet
Mallet W/ Teflon Inserts 19.5cm
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
ASSI.ATK2405619
In Commercial Distribution

  • 00841645130338 ()


  • Surgical mallet
MALLET Ø 20 MM, 75 GRAM LENGTH 165 MM
Gimmi GmbH
KV.1219.02
In Commercial Distribution

  • 04049047709381 ()
KV.1219.02

  • Surgical mallet
CRUCIFORM BLADE SCREWDRIVER
Synthes GmbH
SD03.503.073
In Commercial Distribution

  • 10886982273789 ()
SD03503073

  • Surgical screwdriver, reusable
UNIVERSAL SCREWDRIVER HANDLE
Synthes GmbH
03.133.150
In Commercial Distribution

  • 07612334122162 ()
  • 10886982270351 ()
03133150

  • Surgical screwdriver, reusable
2.5MM HEX DRIVER SHAFT SELF-RETAINING L 100MM QC
Synthes GmbH
03.133.175
In Commercial Distribution

  • 07612334122179 ()
  • 10886982269874 ()
03133175

  • Surgical screwdriver, reusable
T-HANDLE DRIVER
Synthes GmbH
SD03.120.017
In Commercial Distribution

  • 10886982262172 ()
SD03120017

  • Screwing power tool attachment
MAXFRAME(TM) STRUT ID PLUG SET
Synthes GmbH
03.312.821
In Commercial Distribution

  • H679033128210 ()
  • 10886982260994 ()
03312821

  • External orthopaedic fixation system, reusable
MAXFRAME(TM) STRUT ID BAND SET
Synthes GmbH
03.312.820
In Commercial Distribution

  • H679033128200 ()
  • 10886982260987 ()
03312820

  • External orthopaedic fixation system, reusable
T15 SCREWDRIVER SHAFT STARDRIVE/150MM LONG
Synthes GmbH
SD314.112
In Commercial Distribution

  • H679SD3141120 ()
  • 10886982257666 ()
SD314112

  • Surgical screwdriver, reusable
MODIFIED TRINKLE REDUCTION DRIVE UNIT
Synthes GmbH
532.020
In Commercial Distribution

  • 07611819126992 ()
  • H6795320200 ()
  • 10886982240569 ()
532020

  • Reaming power tool attachment
TRINKLE REDUCTION DRIVE UNIT
Synthes GmbH
532.019
In Commercial Distribution

  • 07611819126978 ()
  • H6795320190 ()
  • 10886982240545 ()
532019

  • Reaming power tool attachment
HUDSON REDUCTION DRIVE UNIT
Synthes GmbH
532.018
In Commercial Distribution

  • 07611819118881 ()
  • H6795320180 ()
  • 10886982240521 ()
532018

  • Reaming power tool attachment
AO REDUCTION DRIVE UNIT
Synthes GmbH
532.017
In Commercial Distribution

  • 07611819118874 ()
  • H6795320170 ()
  • 10886982240507 ()
532017

  • Reaming power tool attachment
4.0MM/3.0MM TI SLF-DRLG SCHANZ SCREW 80MM/HA COATING-STERILE
Synthes GmbH
494.771SHA
In Commercial Distribution

  • H679494771SHA0 ()
  • 10886982236401 ()
494771SHA

  • External orthopaedic fixation system, reusable
PRODUCT SUMMARY This is used for insertion and removal of the ATOZ Mini-screw. The driver is designed just for MK Mini-screw (MKS-1611, MKS-1613), so it does not fit other types of mini-screws. INDICATION FOR USE This is used for insertion and removal of the ATOZ Mini-screw TRADE NAME ATOZ Screwdriver MODEL NAME MKD-L COSIST OF MKD-L*1EA
MK Meditech Inc.
MKD-L
In Commercial Distribution

  • 08800197900563 ()


  • Surgical screwdriver, reusable
PRODUCT SUMMARY This is used for insertion and removal of the ATOZ Mini-screw. The driver is designed just for MK Mini-screw (MKS-1611, MKS-1613), so it does not fit other types of mini-screws. INDICATION FOR USE This is used for insertion and removal of the ATOZ Mini-screw TRADE NAME ATOZ Screwdriver MODEL NAME MKD-S COSIST OF MKD-S *1EA
MK Meditech Inc.
MKD-S
In Commercial Distribution

  • 08800197900556 ()


  • Surgical screwdriver, reusable
The ATOZ Expander Kit is a procedure kit used for orthodontic treatment and consists of an expander, screws, drivers, wires, and accessories. ATOZ Expander:MKE-08-F*1ea ATOZ Key: MK Key-L*1ea, MK Key-S*1ea ATOZ Mini-Screw: MKS-1611*8ea ATOZ Screwdriver MKD-S *1ea, MKD-L*1ea ATOZ Tooth connecting arms: MK Wire arm-1240*4ea
MK Meditech Inc.
ATOZ Expander Kit
In Commercial Distribution

  • 08800197900341 ()


  • Surgical screwdriver, reusable
  • Orthodontic archwire
  • Orthodontic anchoring screw
  • Orthodontic palate expander/teeth aligner, bonded
  • Orthodontic palate expander screw key
ATOZ Expander Kit *10SET
MK Meditech Inc.
ATOZ Expander Kit*10SET
In Commercial Distribution

  • 08800197900075 ()


  • Orthodontic palate expander screw key
  • Orthodontic palate expander/teeth aligner, bonded
  • Orthodontic anchoring screw
  • Orthodontic archwire
  • Surgical screwdriver, reusable
The ATOZ Expander Kit is a procedure kit used for orthodontic treatment and consists of an expander, screws, drivers, wires, and accessories. ATOZ Expander:MKE-08-F*1ea ATOZ Key: MK Key-L*1ea, MK Key-S*1ea ATOZ Mini-Screw: MKS-1611*2ea, MKS-1613*8ea ATOZ Screwdriver MKD-S *1ea, MKD-L*1ea ATOZ Tooth connecting arms: MK Wire arm-1240*4ea
MK Meditech Inc.
ATOZ Expander Kit
In Commercial Distribution

  • 08800197900068 ()


  • Surgical screwdriver, reusable
  • Orthodontic archwire
  • Orthodontic anchoring screw
  • Orthodontic palate expander/teeth aligner, bonded
  • Orthodontic palate expander screw key
PRODUCT SUMMARY This is used for insertion and removal of the ATOZ Mini-screw. The driver is designed just for MK Mini-screw (MKS-1611, MKS-1613), so it does not fit other types of mini-screws. INDICATION FOR USE This is used for insertion and removal of the ATOZ Mini-screw TRADE NAME ATOZ Screwdriver MODEL NAME MKD-S and MKD-L COSIST OF MKD-S *1EA + MKD-L*1EA
MK Meditech Inc.
MKD-L and MKD-S
In Commercial Distribution

  • 08800197900051 ()


  • Surgical screwdriver, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
DH
Not in Commercial Distribution

  • 08800177390360 ()


  • Fixture/appliance dental drill bit, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
MGASMD
In Commercial Distribution

  • 08800177387667 ()


  • Fixture/appliance dental drill bit, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
ACND12
In Commercial Distribution

  • 08800177378771 ()


  • Dental implant system
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
OIAD12
In Commercial Distribution

  • 08800177378764 ()


  • Fixture/appliance dental drill bit, reusable
BENDING DRIVER F/ 3.5MM VA LOCKING HOLES
Synthes GmbH
03.221.251
In Commercial Distribution

  • 07612334207944 ()
  • 10886982277022 ()
03221251

  • Manual orthopaedic bender, reusable
8MM TAPERED HEX FLEXIBLE SHAFT DRIVER
Synthes GmbH
SD03.037.028
In Commercial Distribution

  • 10886982275127 ()
SD03037028

  • Surgical screwdriver, reusable
T25 STARDRIVE SCREWDRIVER SHAFT 241MM
Synthes GmbH
03.168.014
In Commercial Distribution

  • 07611819657403 ()
  • 10886982274489 ()
03168014

  • Surgical screwdriver, reusable
3.5MM HEXAGONAL SCREWDRIVER SHAFT 241MM
Synthes GmbH
03.168.016
In Commercial Distribution

  • 07612334081773 ()
  • 10886982274465 ()
03168016

  • Surgical screwdriver, reusable
5MM FLEXIBLE HEX SCREWDRIVER
Synthes GmbH
SD03.037.029
In Commercial Distribution

  • 10886982275134 ()
SD03037029

  • Surgical screwdriver, reusable
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