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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No Description
Jeil Medical Corporation
111-308-1
In Commercial Distribution

  • 08800089409303 ()


  • Surgical screwdriver, reusable
No Description
Jeil Medical Corporation
113-SP-701
In Commercial Distribution

  • 08800089403141 ()


  • Surgical screwdriver, reusable
No Description
Jeil Medical Corporation
113-HF-626
In Commercial Distribution

  • 08800089403134 ()


  • Surgical screwdriver, reusable
No Description
Jeil Medical Corporation
111-308
In Commercial Distribution

  • 08800089402977 ()


  • Surgical screwdriver, reusable
No Description
Jeil Medical Corporation
SO-113-ST-001
In Commercial Distribution

  • 08800089402809 ()


  • Surgical screwdriver, reusable
No Description
Jeil Medical Corporation
SO-113-HF-623
In Commercial Distribution

  • 08800089402731 ()


  • Surgical screwdriver, reusable
No Description
Jeil Medical Corporation
SO-113-HF-716
In Commercial Distribution

  • 08800089400218 ()


  • Surgical screwdriver, reusable
ROD HOLDER MINIATURE SIZE ANGLED TIP
SONTEC INSTRUMENTS, INC.
355-2216
In Commercial Distribution

  • 00192896097612 ()

  • For 5.5 Millimeter Rods
  • Length: 8.25 Inch
355-2216

  • External orthopaedic fixation system, reusable
PLATE HOLDER CERVICAL ANGLED
SONTEC INSTRUMENTS, INC.
355-228
In Commercial Distribution

  • 00192896095427 ()

  • Length: 9 Inch
355-228

  • External orthopaedic fixation system, reusable
BONE MALLET AO TYPE PHENOLIC HANDLE
SONTEC INSTRUMENTS, INC.
330-839
In Commercial Distribution

  • 00192896094451 ()

  • Length: 9 Inch
330-839

  • Surgical mallet
LUBRA SCREWDRIVER PHENOLIC HANDLE
SONTEC INSTRUMENTS, INC.
1106-965
In Commercial Distribution

  • 00192896093669 ()

  • Length: 6.75 Inch
1106-965

  • Surgical screwdriver, reusable
SONTEC KEYLESS I.M. PIN DRILL CHUCK WITH LOCK SYSTEM STAINLESS STEEL
SONTEC INSTRUMENTS, INC.
1103-194-SET
In Commercial Distribution

  • 00192896090934 ()

  • Length: 0.375 Inch
1103-194-SET

  • External orthopaedic fixation system, reusable
HYBRID KEY FOR 0.375 INCH CHUCK
SONTEC INSTRUMENTS, INC.
1103-193K
In Commercial Distribution

  • 00192896090927 ()
1103-193K

  • External orthopaedic fixation system, reusable
HYBRID CHUCK SET ALUMINIUM HANDLE
SONTEC INSTRUMENTS, INC.
1103-193-SET
In Commercial Distribution

  • 00192896090910 ()

  • Length: 0.375 Inch
1103-193-SET

  • External orthopaedic fixation system, reusable
MAKITA DRILL SHROUD
SONTEC INSTRUMENTS, INC.
1103-192
In Commercial Distribution

  • 00192896090903 ()
1103-192

  • External orthopaedic fixation system, reusable
SONTEC I.M. PIN ALUMINIUM HANDLE
SONTEC INSTRUMENTS, INC.
1103-191H
In Commercial Distribution

  • 00192896090897 ()
1103-191H

  • External orthopaedic fixation system, reusable
JACOBS CHUCK & KEY
SONTEC INSTRUMENTS, INC.
1103-189
In Commercial Distribution

  • 00192896090880 ()

  • Length: 0.15625 Inch
1103-189

  • External orthopaedic fixation system, reusable
SONTEC I.M. PIN CHUCK HANDLE EXTENSION
SONTEC INSTRUMENTS, INC.
1103-187
In Commercial Distribution

  • 00192896090873 ()
1103-187

  • External orthopaedic fixation system, reusable
SONTEC I.M. PIN CHUCK KEY EXTENTION HANDLE
SONTEC INSTRUMENTS, INC.
1103-186X
In Commercial Distribution

  • 00192896090866 ()
1103-186X

  • External orthopaedic fixation system, reusable
SONTEC I.M. PIN KEY STAINLESS STEEL
SONTEC INSTRUMENTS, INC.
1103-184K
In Commercial Distribution

  • 00192896090859 ()

  • Length: 0.3125 Inch
1103-184K

  • External orthopaedic fixation system, reusable
VICKERS K-WIRE PIN BENDER BLACK COATED
SONTEC INSTRUMENTS, INC.
1103-178A
In Commercial Distribution

  • 00192896088535 ()

  • Length: 3.5 Inch
  • 1 x 1.2 Millimeter Diameter
1103-178A

  • Manual orthopaedic bender, reusable
SECURESPAN SCREW DRIVER
Aesculap AG
FG848R
In Commercial Distribution

  • 04046963593704 ()
FG848R

  • Orthopaedic prosthesis implantation positioning instrument, reusable
S4 ELEMENT POLYAXIAL SCREW DRIVER
Aesculap AG
FW277R
In Commercial Distribution

  • 04046963564148 ()
FW277R

  • Orthopaedic prosthesis implantation positioning instrument, reusable
A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.
OSUNG MND Co., Ltd.
BSWDTL
In Commercial Distribution

  • 08800075611246 ()


  • Surgical screwdriver, reusable
A hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. This is a reusable device.
OSUNG MND Co., Ltd.
ML29
In Commercial Distribution

  • 08800075610379 ()


  • Surgical mallet
A hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. This is a reusable device.
OSUNG MND Co., Ltd.
ML25
In Commercial Distribution

  • 08800075610355 ()


  • Surgical mallet
A hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. This is a reusable device.
OSUNG MND Co., Ltd.
ML20
In Commercial Distribution

  • 08800075610331 ()


  • Surgical mallet
No Description
OSTEONIC CO.,Ltd.
PIS-0430-DRIVER
In Commercial Distribution

  • 08800071020967 ()


  • Surgical screwdriver, reusable
No Description
Izenimplant Co., Ltd.
BICD50LS
In Commercial Distribution

  • 08800070236864 ()


  • Surgical screwdriver, reusable
No Description
Izenimplant Co., Ltd.
BICD50SS
In Commercial Distribution

  • 08800070236857 ()


  • Surgical screwdriver, reusable
No Description
Izenimplant Co., Ltd.
BICD40LS
In Commercial Distribution

  • 08800070236840 ()


  • Surgical screwdriver, reusable
No Description
Izenimplant Co., Ltd.
BICD40SS
In Commercial Distribution

  • 08800070236833 ()


  • Surgical screwdriver, reusable
No Description
Izenimplant Co., Ltd.
BICD5014S
In Commercial Distribution

  • 08800070235065 ()


  • Surgical screwdriver, reusable
No Description
Izenimplant Co., Ltd.
BICD5018L
In Commercial Distribution

  • 08800070235003 ()


  • Surgical screwdriver, reusable
No Description
Izenimplant Co., Ltd.
BICD4014S
In Commercial Distribution

  • 08800070234945 ()


  • Surgical screwdriver, reusable
No Description
Izenimplant Co., Ltd.
BICD4018L
In Commercial Distribution

  • 08800070234877 ()


  • Surgical screwdriver, reusable
No Description
Izenimplant Co., Ltd.
MSADSC20
In Commercial Distribution

  • 08800070233597 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
Izenimplant Co., Ltd.
ZGFDRRW23W
In Commercial Distribution

  • 08800070231562 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
Izenimplant Co., Ltd.
ZGFDRTW25W
In Commercial Distribution

  • 08800070231555 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
Izenimplant Co., Ltd.
ZGFDRSW25W
In Commercial Distribution

  • 08800070231548 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
Izenimplant Co., Ltd.
ZGFDRRR23R
In Commercial Distribution

  • 08800070231531 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
Izenimplant Co., Ltd.
ZGFDRTR25R
In Commercial Distribution

  • 08800070231524 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
Izenimplant Co., Ltd.
ZGFDRTM21R
In Commercial Distribution

  • 08800070231517 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
Izenimplant Co., Ltd.
ZGFDRSR25R
In Commercial Distribution

  • 08800070231500 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
Izenimplant Co., Ltd.
ZGFDRSM25R
In Commercial Distribution

  • 08800070231494 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
Izenimplant Co., Ltd.
ZGFDRRM23M
In Commercial Distribution

  • 08800070231487 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
Izenimplant Co., Ltd.
ZGFDRTM21M
In Commercial Distribution

  • 08800070231470 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
Izenimplant Co., Ltd.
ZGFDRSM25M
In Commercial Distribution

  • 08800070231463 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
Izenimplant Co., Ltd.
ZGFDRSN21M
In Commercial Distribution

  • 08800070231456 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
Izenimplant Co., Ltd.
ZGFDCRW23W
In Commercial Distribution

  • 08800070231449 ()


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