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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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Acuitive Technologies, Inc.
70-811-0001
In Commercial Distribution

  • 00810027270283 ()
70-811-0001

  • Orthopaedic bone wire
  • Wire/ligature passer, single-use
Prime&Bond® NT™ Total Etch Adhesive Bottle Economy Package
DENTSPLY INTERNATIONAL INC.
634351
In Commercial Distribution

  • D00263435162 ()
  • D0026343511 ()

  • Total Volume: 3 Milliliter
  • 3 Bottles Adhesive, 120 Disposable Brush Tips, 1 Brush Handle, 2 Syringes Tooth Conditioner Gel, 75 Applicator Tips (Needles), 1 Dispensing Well
  • Total Volume: 4.5 Milliliter
634351

  • Dentine adhesive
Schocket Scleral Depressor, Side 1: T-Shaped Hammer Head tip, Slightly Angled 16mm from bend to tip, Side 2: Half Ball-Shaped tip, Slightly Angled 16mm from bend to tip, Flat Handle with Pocket clip, 137mm total length, Stainless Steel
Diamatrix
H880
In Commercial Distribution

  • 00813059016546 ()
H880

  • Ocular hook/spatula/manipulator, reusable
Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 72"L (2.5cm x 8.1cm Face to 15.2cm x 183cm), Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled
SHEATHING TECHNOLOGIES, INC.
5-IL726
In Commercial Distribution

  • 00842418104433 ()
  • 10842418104430 ()
  • 20842418104437 ()


  • Body-surface ultrasound imaging transducer cover
  • Topical coupling gel, sterile
The Venus Freeze (MP)2 system is a non invasive device intended for use in dermatologic and general procedures for females for the non invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin I-IV.
VENUS CONCEPT LTD
FRWMUS250025E
In Commercial Distribution

  • 07290016540161 ()


  • Radio-frequency skin surface treatment system
ATRAMAT PGLA90 SURGICAL SUTURE VIOLET USP 3-0 EP 2, 70 CM NEEDLE SGH-36 PREMIUM HEAVY TAPER POINT 36 MM 5/8 CIRCLE PGLA90 VIOLETA USP 3-0, 70 CM AGUJA SGH-36 AHUSADA GRUESA PREMIUM 36 MM 5/8 CIRCULO
Internacional Farmacéutica, S.A. de C.V.
PGLA90
In Commercial Distribution

  • 07500142134531 ()
  • 07500142034534 ()

  • Length: 36 Millimeter
  • 5/8 CIRCLE
  • SUTURE VIOLET
  • ATRAMAT PGLA90
  • USP 3-0
SGH36303

  • Poliglecaprone suture
ATRAMAT PGC25 SURGICAL SUTURE VIOLET USP 3-0 EP 2, 70 CM NEEDLE SGH-26 PREMIUM HEAVY TAPER POINT 26 MM 5/8 CIRCLE PGC25 VIOLETA USP 3-0, 70 CM AGUJA SGH-26 AHUSADA GRUESA PREMIUM 26 MM 5/8 CIRCULO
Internacional Farmacéutica, S.A. de C.V.
PGC25
In Commercial Distribution

  • 07500142116896 ()
  • 07500142016899 ()

  • Length: 26 Millimeter
  • 5/8 CIRCLE
  • SUTURE VIOLET
  • ATRAMAT PGC25
  • USP 3-0
SGH2603

  • Poliglecaprone suture
The STROPP (Single Tunnel Repair of Plantar Plate) System is a sterile packaged kit that include PEEK implants and related instruments for plantar plate repair. Implants are packaged with the following manual surgical instruments for general use: a needle, needle passer, suture passer, an inserter, K-wires and distractor. The implants are compatible with Size 0 suture; suture is not included with the system. The STROPP System is intended for use with a suture in metatarsal ligament and tendon repairs.
CROSSROADS EXTREMITY SYSTEMS
STRoPP Plantar Plate Repair Kit - Sterile
In Commercial Distribution

  • 00815432023097 ()

  • 3.0mm Diameter x 8.0mm Length
1601-0000

  • Suturing needle holder, single-use
  • Suturing needle holder, reusable
  • Orthopaedic surgical distractor, internal
  • Tendon/ligament bone anchor, non-bioabsorbable
  • Bone-resection orthopaedic reamer, reprocessed
  • Bone-resection orthopaedic reamer, single-use
  • Orthopaedic bone wire
  • Orthopaedic inorganic implant inserter/extractor, reusable
  • Suturing unit, single-use
  • Suturing needle, single-use
The STROPP (Single Tunnel Repair of Plantar Plate) System is a sterile packaged kit that include PEEK implants and related instruments for plantar plate repair. Implants are packaged with the following manual surgical instruments for general use: a needle, needle passer, suture passer, an inserter, K-wires and distractor. The implants are compatible with Size 0 suture; suture is not included with the system. The STROPP System is intended for use with a suture in metatarsal ligament and tendon repairs.
CROSSROADS EXTREMITY SYSTEMS
1601-0001
In Commercial Distribution

  • 00815432023264 ()

  • 3.0mm Diameter x 8.0mm Length
1601-0001

  • Suturing needle holder, single-use
  • Suturing needle holder, reusable
  • Orthopaedic surgical distractor, internal
  • Tendon/ligament bone anchor, non-bioabsorbable
  • Bone-resection orthopaedic reamer, reprocessed
  • Bone-resection orthopaedic reamer, single-use
  • Orthopaedic bone wire
  • Orthopaedic inorganic implant inserter/extractor, reusable
  • Suturing unit, single-use
  • Suturing needle, single-use
Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 3.2" Face to 6"W x 58"L (2.5cm x 8.1cm Face to 15.2cm x 147cm), Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled
SHEATHING TECHNOLOGIES, INC.
ADH-5-IL586
In Commercial Distribution

  • 20842418104420 ()
  • 10842418104423 ()
  • 00842418104426 ()


  • Body-surface ultrasound imaging transducer cover
  • Topical coupling gel, sterile
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