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
GE Healthcare Finland Oy
ECG Leadwire set, 5-lead, grouped, snap, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in
In Commercial Distribution

  • 00840682139816 ()
2106383-006

  • Electrocardiographic lead set, reusable
No Description
GE Healthcare Finland Oy
ECG Leadwire set, 5-lead, grouped, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in
In Commercial Distribution

  • 00840682139786 ()
2106389-005

  • Electrocardiographic lead set, reusable
No Description
GE Healthcare Finland Oy
ECG Leadwire set, 6-lead, grouped, grabber, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in
In Commercial Distribution

  • 00840682139717 ()
2106398-003

  • Electrocardiographic lead set, reusable
No Description
GE Healthcare Finland Oy
ECG Leadwire set, 6-lead, grouped, snap, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in
In Commercial Distribution

  • 00840682139663 ()
2106395-003

  • Electrocardiographic lead set, reusable
Grafting Instrument Kit (11 Instruments)
GoldenDent
GO GKI
In Commercial Distribution

  • 00850011211946 ()
GO GKI

  • Bone file/rasp, manual, reusable
  • Suture scissors
  • Bone curette, reusable
  • Suturing needle holder, reusable
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Periodontal knife
  • Periosteal elevator, reusable
  • Scalpel handle, reusable
  • Dappen dish, reusable
Advanced Grafting Kit (11 Instruments and Cassette)
GoldenDent
GO AGK
In Commercial Distribution

  • 00850011211939 ()
GO AGK

  • Bone file/rasp, manual, reusable
  • Instrument tray, reusable
  • Suture scissors
  • Bone curette, reusable
  • Suturing needle holder, reusable
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Periodontal knife
  • Periosteal elevator, reusable
  • Scalpel handle, reusable
  • Dappen dish, reusable
Gri-fill 2 Ways Set is a fluid transfer set for use with the Gri-fill pharmacy compounding device in order to compound or mix different multi-ingredient solutions and to channel them into a final suitable IV container. The set is a disposable component of the compounding device. Gri-fill 2 Ways Set is made up of a syringe, a distributor, tubing to channel the fluid and a waste/residue bag. Set is available for 1 or 2 source substances. Also a Luer female - female adapter is available as an accessory to the Gri-fill 2 Ways Set.
LABORATORIOS GRIFOLS SA
GRI-FILL 2 Ways Set
In Commercial Distribution

  • 08426314575768 ()
  • 28426314575762 ()


  • Fluid transfer set, general-purpose
The Chitogel Endoscopic Sinus Surgery Kit consists of the following components: - Sealed vial containing 350mg Dextran Aldehyde Powder - Sealed vial containing 12ml Sodium Phosphate Buffer Solution - Sealed vial containing 12ml Chitosan Succinamide Solution - Fluid dispensing connector - Two (2) mixing cannulae - Malleable cannulae - Two (2) 20ml sterile luer lock syringe The Chitogel Endoscopic Sinus Surgery Kit is used during nasal surgery. The components in the Chitogel Kit are mixed by the physician using the two 20 ml sterile syringe and cannulae provided. The pre-measured components mix to form the biodegradable gel. Once the components are mixed and create the gel, the physician applies the gel to the target area using the malleable cannula and thereby creating a nasal packing. All components are provide sterile and are for single use only.
CHITOGEL LIMITED
CSK-4
In Commercial Distribution

  • 09400998100040 ()
CSK-4

  • Intranasal splint, biodegradable
PhaseII® Dual Cure is intended for use as an orthodontic adhesive for direct and indirect bonding. Phase II® DUAL CURE combines the best of both chemical and light cure polymerization. The chemical cure working time is 4 minutes to allow several brackets to be set and positioned from one mix. An initial set can be immediately achieved by light curing from any angle for 10 seconds. This will prevent the loss of bond strength due to saliva contamination. This unique dual cure process allows complete polymerization under metal brackets where the light does not reach. When an immediate final set is desired, simply light cure a metal or ceramic bracket for 30 seconds. This kit contains paste in 18g jars A & B and 2 X 3cc Sealant Resin and 1 9g etchant. Contains Fluoride
RELIANCE ORTHODONTIC PRODUCTS INC
DCJF
Not in Commercial Distribution

  • D798DCJF0 ()
DCJF

  • Dental material application tool, single-use
ADSEAL Plus root canal sealer is a two component paste:paste device based upon epoxy-amine resin chemistry. This sealer is easy to mix and adapts closely to the walls of the prepared root canal and provides outstanding long-term dimensional stability with minimal shrinkage upon setting. The device consists of two components, the epoxy resin paste (Paste A) and the aminecontaining paste (Paste B); portions of which are mixed prior to insertion into the root canal. This two component system reacts via an epoxide-amine chemical reaction to cause setting. It may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points). Paste A and Paste B are contained, separately, with the chambers of a two component plastic syringe, packaged with a disposable applicator. The ADSEAL Plus device is similar in design, materials and intended use to other 510(k) cleared devices which are in commercial distribution.
Meta Biomed Co., Ltd.
9478
In Commercial Distribution

  • 08806387894780 ()


  • Dental epoxy resin
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