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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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INSTRUMENT 7480325 PRVSNL DRIVER 8MM HEX
MEDTRONIC SOFAMOR DANEK, INC.
7480325
In Commercial Distribution

  • 00721902908101 ()


  • Surgical drill guide, reusable
The MML Specimen Collection Swab is an absorbent polyester-tipped applicator intended for medical purposes that consists of an absorbent polyester swab bud adhered to a plastic shaft. The single use device is intended to collect a specimen from a patient. The MML Specimen Collection Swab is a Class 1 sterile device. Note: MML’s customers purchase this swab to be a component of their specimen collection/testing kits, as specified by the customer. This swab is only distributed as a component of a customer’s collection/testing kit and is not sold or distributed as a stand-alone device. The MML Specimen Collection Swab is intended to be used for the collection of a broad spectrum of specimens including human clinical specimens, as defined by the customer’s specific collection kit.
Mml Diagnostics Packaging, Inc.
CD215
In Commercial Distribution

  • 00862255000347 ()
CD215

  • General-purpose absorbent tip applicator/swab, single-use
The MML Specimen Collection Swab is an absorbent polyester-tipped applicator intended for medical purposes that consists of an absorbent polyester swab bud adhered to a plastic shaft. The single use device is intended to collect a specimen from a patient. The MML Specimen Collection Swab is a Class 1 sterile device. Note: MML’s customers purchase this swab to be a component of their specimen collection/testing kits, as specified by the customer. This swab is only distributed as a component of a customer’s collection/testing kit and is not sold or distributed as a stand-alone device. The MML Specimen Collection Swab is intended to be used for the collection of a broad spectrum of specimens including human clinical specimens, as defined by the customer’s specific collection kit.
Mml Diagnostics Packaging, Inc.
CD650
In Commercial Distribution

  • 00862255000330 ()
CD650

  • General-purpose absorbent tip applicator/swab, single-use
The MML Specimen Collection Swab is an absorbent polyester-tipped applicator intended for medical purposes that consists of an absorbent polyester swab bud adhered to a plastic shaft. The single use device is intended to collect a specimen from a patient. The MML Specimen Collection Swab is a Class 1 sterile device. Note: MML’s customers purchase this swab to be a component of their specimen collection/testing kits, as specified by the customer. This swab is only distributed as a component of a customer’s collection/testing kit and is not sold or distributed as a stand-alone device. The MML Specimen Collection Swab is intended to be used for the collection of a broad spectrum of specimens including human clinical specimens, as defined by the customer’s specific collection kit.
Mml Diagnostics Packaging, Inc.
CD651
In Commercial Distribution

  • 00862255000323 ()
CD651

  • General-purpose absorbent tip applicator/swab, single-use
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
SB-CBA43-1
In Commercial Distribution

  • 05712821013057 ()
  • 05712821013194 ()
SB-CBA34-1

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
SB-CAS50-1
In Commercial Distribution

  • 05712821013040 ()
  • 05712821013187 ()
SB-CAS50-1

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
SB-CAS43-1
In Commercial Distribution

  • 05712821013033 ()
  • 05712821013170 ()
SB-CAS43-1

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
SB-CAS38-1
In Commercial Distribution

  • 05712821013026 ()
  • 05712821013163 ()
SB-CAS38-1

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
SB-CAS33-1
In Commercial Distribution

  • 05712821013019 ()
  • 05712821013156 ()
SB-CAS33-1

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
SB-BCE41-1
In Commercial Distribution

  • 05712821013002 ()
  • 05712821013149 ()
SB-BCE41-1

  • Dental implant suprastructure, temporary, preformed, reusable
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