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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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UNO NPWT 70CC Collection Canister - 00849405001058

The UNO Canister comes in only 1 size, which is 70cc. It has a solidifier gel sheet inside to solidify any collected exudates. The canister is made out of ABS plastic material. At the suction interface, where it is connected to the UNO pump, there is a hydrophobic filter welded to it. The filter has a 0.2 micron pore size, which has a bacteria filtration efficiency (BFE) of over 99%. The UNO canister is a disposable single use item. It comes packaged in a medical grade paper pouch.
GENADYNE BIOTECHNOLOGIES INC.
U-C070
In Commercial Distribution

  • 00849405001058 ()


  • Negative-pressure wound therapy system canister

eShield Digital Camera Size - M266EC22000

The Whitney Medical Solutions’ eShield consists of polyethylene film (and an adhesive pad in some models) with tear guide tape and a zipper that allows the cover to be torn fairly straight across it. There is also a double sided tape below the zipper that is used as a redundant closure method with the cover being folded twice and sealed against it. The device is provided to the user sterile, is labeled for single use only and not intended for resterilization or reprocessing. The sterile eShield is sterilized using a validated irradiation sterilization method.
Whitney Medical Solutions
EC2200
Not in Commercial Distribution

  • M266EC22001 ()
  • M266EC22000 ()


  • Patient surgical drape, single-use

Cutting Guide Angle Adaptor (SI Right Knee / IS Left Knee) 2.5 Degree - 05065012584486

Allows for a small adjustment resection of the patella in an angled plane superior to inferior or inferior to superior dependant on knee side
EVENTUM ORTHOPAEDICS LTD
AA018
In Commercial Distribution

  • 05065012584486 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Cutting Guide Angle Adaptor (SI Left Knee / IS Right Knee) 2.5 Degree - 05065012584479

Allows for a small adjustment resection of the patella in an angled plane superior to inferior or inferior to superior dependant on knee side
EVENTUM ORTHOPAEDICS LTD
AA017
In Commercial Distribution

  • 05065012584479 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

T-RING FLEX Digit Tourniquet - 00869193000057

The T-RING FLEX is a non-pneumatic tourniquet for digits (fingers and toes). It is one size fits all, and automatically adjusts to the size of the digit to apply a safe and effective pressure (approximately 150 mm Hg). It is completely flexible and fits nicely in small spaces; i.e. pediatric fingers and toes.
PRECISION MEDICAL DEVICES, LLC
TR002
In Commercial Distribution

  • 00869193000040 ()
  • 00869193000057 ()


  • Digit tourniquet, manual

i-Thread - 08800056425329

i-Thread (Absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2.
Hyundae Meditech Co., Ltd.
FCHL19100E160
In Commercial Distribution

  • 08800056425329 ()
  • 48800056425327 ()
  • 88800056425325 ()

  • Length: 160 Millimeter


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial

i-Thread - 08800056425305

i-Thread (Absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2.
Hyundae Meditech Co., Ltd.
FCHL1960E90
In Commercial Distribution

  • 08800056425305 ()
  • 48800056425303 ()
  • 88800056425301 ()

  • Length: 90 Millimeter


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial

i-Thread - 08800056425299

i-Thread (Absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2.
Hyundae Meditech Co., Ltd.
FCL18100C160
In Commercial Distribution

  • 08800056425299 ()
  • 48800056465293 ()
  • 88800056425295 ()

  • Length: 120 Millimeter


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial

i-Thread - 08800056425183

i-Thread (Absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2.
Hyundae Meditech Co., Ltd.
FCRL1970E162
In Commercial Distribution

  • 08800056425183 ()
  • 48800056425181 ()
  • 88800056425189 ()

  • Length: 162 Millimeter


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial

i-Thread - 08800056425176

i-Thread (Absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2.
Hyundae Meditech Co., Ltd.
FCRL18100C185
In Commercial Distribution

  • 08800056425176 ()
  • 48800056425174 ()
  • 88800056425172 ()

  • Length: 185 Millimeter


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
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