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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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Morphix - M9701000041250

MORPHIX Foot & Ankle 2.5mm x 7mm Anchor with one suture, double armed with needles
Medshape, Inc.
1000-04-125
In Commercial Distribution

  • M9701000041250 ()


  • Tendon/ligament bone anchor, non-bioabsorbable

HELMUT ZEPF - EZPF19710180

SYRINGE, CARTRIDGE BREECH LOADING SYSTEM, WITH 3 ASPIRAT. WITH 3 ASPIRATION HOOKS , 1.8 ML
Helmut Zepf Medizintechnik GmbH
19.710.18
In Commercial Distribution

  • EZPF19710180 ()
19.710.18

  • Dental anaesthesia syringe, reusable

PHASOR - B775PH45070DTPHKA1S0

Phasor Drill, 4.50-mm diameter, with Drill Stop Extension (Tapered) with Kit (version A1), Stapler
PHASOR HEALTH LLC
PH-450-70-DT+PH-K-A1S
In Commercial Distribution

  • B775PH45070DTPHKA1S0 ()


  • Cranial trephine, single-use
  • Neurosurgical procedure kit, medicated

PHASOR - B775450K0

Phasor Drill, 4.50-mm diameter, with Drill Stop Extension (Tapered) with Kit (version A1), Stapler
PHASOR HEALTH LLC
4.50K
In Commercial Distribution

  • B775450K0 ()
4.50K

  • Automatic cranial perforator, single-use
  • Skin stapler/staple, non-bioabsorbable
  • Neurosurgical procedure kit, medicated

Myotrode One without Gel - D79240702

Non-jelled TENS Electrodes for use with Myomonitor.Designed for patients with sideburns or a beard.
MYOTRONICS NOROMED, INC
4070
In Commercial Distribution

  • D79240702 ()


  • Transcutaneous electrical stimulation electrode, single-use

Hospira - 10887787007173

LATEX-FREE MICROBORE EXTENSION SET, 60 Inch with Female Adapter with Wings and Secure Lock
HOSPIRA, INC.
1336048
In Commercial Distribution

  • 20887787007170 ()
  • 10887787007173 ()
  • M33513360482 ()

  • Length: 60 Inch
  • Approximate priming volume : 2 Milliliter
1336048

  • Electric infusion pump administration set, single-use

T2Biothreat® QCheck Positive Kit - M70885113963

Buffer based solution with containing non-pathogenic bacterial strains with the T2Biothreat Panel target sequences.
T2 BIOSYSTEMS, INC.
85-11396
In Commercial Distribution

  • M70883113950 ()
  • M70885113963 ()


  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control

Surgical Direct - B382SD9019000

5mm 32cm Dolphin Nose Grasper with Non-Locking Handle, Rotating with Flushport and Tube Assembly
Surgical Direct, Inc.
SD901-900
In Commercial Distribution

  • B382SD9019000 ()
SD901-900

  • Laparoscopic tissue manipulation forceps/working-channel

Surgical Direct - B382SD89959000

5mm Medium Curved Dissector Insert, Standard Length with Monopolar Rotating Non Locking Handle with
Surgical Direct, Inc.
SD8995-900
In Commercial Distribution

  • B382SD89959000 ()
SD8995-900

  • Laparoscopic tissue manipulation forceps/working-channel

Surgical Direct - B382SD89949000

5mm Stevy Grasper, Double Action, 20.9mm Jaw, Standard Length with with Non-Locking Comfort Handle
Surgical Direct, Inc.
SD8994-900
In Commercial Distribution

  • B382SD89949000 ()
SD8994-900

  • Laparoscopic tissue manipulation forceps/working-channel
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