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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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(2) Eagle Screw-in Suture Anchor - 4.5mm (2) Eagle Knotless Suture Anchor - 4.75mm (1) Eagle Drill Guide (1) Eagle Drill 3.5mm (1) Eagle Drill 3.8mm (1) Eagle Tap 4.5mm
RESPONSIVE ORTHOPEDICS LLC
285955
In Commercial Distribution

  • 00811714036434 ()
285955

  • Tendon/ligament bone anchor, non-bioabsorbable
  • Fluted surgical drill bit, single-use
  • Surgical drill guide, single-use
  • Bone tap, single-use
(2) Eagle Screw-in Suture Anchor - 5.5mm (2) Eagle Knotless Suture Anchor - 5.5mm (1) Eagle Drill Guide (1) Eagle Drill 3.5mm (1) Eagle Drill 4.4mm (1) Eagle Tap 5.5mm
RESPONSIVE ORTHOPEDICS LLC
913000-5500
In Commercial Distribution

  • 00811714035932 ()
913000-5500

  • Tendon/ligament bone anchor, non-bioabsorbable
  • Fluted surgical drill bit, single-use
  • Surgical drill guide, single-use
  • Bone tap, single-use
(2) Eagle Screw-in Suture Anchor - 4.5mm (2) Eagle Knotless Suture Anchor - 4.75mm (1) Eagle Drill Guide (1) Eagle Drill 3.5mm (1) Eagle Drill 3.8mm (1) Eagle Tap 4.5mm
RESPONSIVE ORTHOPEDICS LLC
913000-4500
In Commercial Distribution

  • 00811714035925 ()
913000-4500

  • Tendon/ligament bone anchor, non-bioabsorbable
  • Fluted surgical drill bit, single-use
  • Surgical drill guide, single-use
  • Bone tap, single-use
RAPIDSORB IPS BATTERY PACK STERILE
Synthes GmbH
530.553.01S
In Commercial Distribution

  • H98053055301S0 ()
  • 10887587057262 ()
53055301S

  • Craniofacial bone tack, bioabsorbable
  • Portable/mobile rechargeable battery pack
RAPIDSORB IPS POWER DRIVE UNIT
Synthes GmbH
530.551
In Commercial Distribution

  • H9805305510 ()
  • 10887587057255 ()
530551

  • Bone/joint surgical power tool motor, electric
  • Craniofacial bone tack, bioabsorbable
Barium Impregnated Ventricular Catheter
NATUS MEDICAL INCORPORATED
NT99023S01
In Commercial Distribution


  • Tubing: 1.3mm ID x 2.5mm OD; Total Length: 23cm (all dimensions nominal)
NT99023S01

  • Intracerebral infusion/drainage catheter, short-term
  • Intracerebral infusion/drainage catheter, long-term
Integra Ventricular Catheter 23 CM BARIUM IMPREG. VENTRICULAR CATHETER
Integra Lifesciences Corporation
NL99023S01
In Commercial Distribution

  • 10381780071204 ()
  • M269NL99023S011 ()

  • Tubing: 1.3mm ID x 2.5mm OD; Total Length: 23cm (all dimensions nominal)
NL99023S01

  • Intracerebral infusion/drainage catheter, long-term
  • Intracerebral infusion/drainage catheter, short-term
SUPPLE PERI-GUARD Repair Patch is prepared from bovine pericardium cross-linked with glutaraldehyde. The tissue, procured from cattle originating in the USA is chemically sterilized using ethanol and propylene oxide, and treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is MR safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC1016SN
In Commercial Distribution

  • 00085412530710 ()
PC1016SNBIO

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD Repair Patch is prepared from bovine pericardium cross-linked with glutaraldehyde. The tissue, procured from cattle originating in the USA is chemically sterilized using ethanol and propylene oxide, and treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is MR safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0814SN
In Commercial Distribution

  • 00085412530697 ()
PC0814SNBIO

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD Repair Patch is prepared from bovine pericardium cross-linked with glutaraldehyde. The tissue, procured from cattle originating in the USA is chemically sterilized using ethanol and propylene oxide, and treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is MR safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0608SN
In Commercial Distribution

  • 00085412530673 ()
PC0608SNBIO

  • Cardiovascular patch, animal-derived
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