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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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ACL Procedure Pack, Sterile
Medshape, Inc.
1101-02-000
In Commercial Distribution

  • M9701101020000 ()
  • M97013000102404 ()


  • Orthopaedic bone wire
  • Suturing unit, single-use
  • Ligament graft sizer, noninvasive
  • Bone tunnel plug, cannulated
  • Skin marking pen, single-use
The Ultravision2 IonPencil™ is a bifunctional open surgery device that combines proprietary smoke management (via visual field clearing) and monopolar HF tissue cutting and coagulation in a single device. It’s addition to the Ultravision2 System adds the general open procedure capability to the Ultravision2™ indications of use along with the new single use accessory.
ALESI SURGICAL LIMITED
DPD-007-001
In Commercial Distribution

  • 15060417680495 ()
  • 05060417680498 ()
  • 25060417680492 ()
DPD-007-001

  • Surgical plume evacuation system
SubQ It! Bioabsorbable Driver SU-10 is a single-patient use, skin closure device, preloaded with 10 bioabsorbable dermal fasteners, packaged sterile in a protective foil pouch.
OPUS KSD, INC.
SU-10
In Commercial Distribution

  • 10867469000234 ()
  • 00867469000237 ()
412010

  • Skin stapler/staple, bioabsorbable
SubQ It! Bioabsorbable Driver SU-10 is a single-patient use, skin closure device, preloaded with 10 bioabsorbable dermal fasteners, packaged sterile in a protective foil pouch.
OPUS KSD, INC.
SU-10
In Commercial Distribution

  • 10867469000227 ()
  • 00867469000220 ()
412010

  • Skin stapler/staple, bioabsorbable
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
DRILL - CANNULATED 4.5mm DIA x 204mm
DE SOUTTER MEDICAL LIMITED
D57-450
In Commercial Distribution

  • 15051471132761 ()
  • 05051471132764 ()
D57-450

  • Cannulated surgical drill bit, single-use
SOTIRAKIS SINUS LIFT HYDRAULIC INSTRUMENT 3.3MM LONG W/DRIVER SS 17(H900)
ACE SURGICAL SUPPLY CO., INC.
45408501
In Commercial Distribution

  • 00614950031382 ()
45408501

  • Dental elevator, tooth/root
ORTHODONTIC 1.25MM BONE SCREWDRIVER 55TL SS 17-4 H90
ACE SURGICAL SUPPLY CO., INC.
45417501
In Commercial Distribution

  • 00614950031313 ()
45417501

  • Orthopaedic implant driver
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