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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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Simpex Drill Bit - B068DB171101

Twist Drill Bit .171" DIA x 10" LG
SIMPEX MEDICAL, INC.
DB-171-10
In Commercial Distribution

  • B068DB171101 ()

  • Outer Diameter: 4.3 Millimeter
DB-171-10

  • Fluted surgical drill bit, single-use, non-sterile

Simpex Drill Bit - B068DB156101

Twist Drill Bit .156" DIA x 10" LG
SIMPEX MEDICAL, INC.
DB-156-10
In Commercial Distribution

  • B068DB156101 ()

  • Outer Diameter: 4.0 Millimeter
DB-156-10

  • Fluted surgical drill bit, single-use, non-sterile

Simpex Drill Bit - B068DB125101

Twist Drill Bit .125" DIA x 10" LG
SIMPEX MEDICAL, INC.
DB-125-10
In Commercial Distribution

  • B068DB125101 ()

  • Outer Diameter: 3.2 Millimeter
DB-125-10

  • Fluted surgical drill bit, single-use, non-sterile

MATIRA ANTERIOR CERVICAL SYSTEM - B07307STV45101

SCREW, 4.5 X 10 MM SELF TAPPING VARIABLE
Kalitec Direct LLC
07-STV-4510
In Commercial Distribution

  • B07307STV45101 ()
07-STV-4510

  • Spinal bone screw, non-bioabsorbable

MATIRA ANTERIOR CERVICAL SYSTEM - B07307STV40101

SCREW, 4 X 10 MM SELF TAPPING VARIABLE
Kalitec Direct LLC
07-STV-4010
In Commercial Distribution

  • B07307STV40101 ()
07-STV-4010

  • Spinal bone screw, non-bioabsorbable

MATIRA ANTERIOR CERVICAL SYSTEM - B07307STF40101

SCREW, 4 X 10 MM SELF TAPPING FIXED
Kalitec Direct LLC
07-STF-4010
In Commercial Distribution

  • B07307STF40101 ()
07-STF-4010

  • Spinal bone screw, non-bioabsorbable

6-Acetylmorphine DAU Calibrator, Cutoff Calibrator - B07602930

5mL/bottle. Concentration: 10 ng/mL of 6-Acetylmorphine.
LIN-ZHI INTERNATIONAL, INC.
0293
In Commercial Distribution

  • B07602930 ()
0293

  • 6-Acetyl morphine IVD, calibrator

Norbuprenorphine DAU Calibrator, Cutoff Calibrator #2 - B07602750

5mL/bottle. Concentration: 10 ng/mL of Norbuprenorphine.
LIN-ZHI INTERNATIONAL, INC.
0275
In Commercial Distribution

  • B07602750 ()
0275

  • Buprenorphine IVD, calibrator

NA - B013DRUJLP100

Distal Radio-Ulnar Joint Locking Plate Assembly, Size 10
APTIS MEDICAL, LLC
DRUJ-LP10
In Commercial Distribution

  • B013DRUJLP100 ()
DRUJ-LP10

  • Wrist ulna-head prosthesis

Surgical Direct - B382SD922764030

7 inch Ferris-Smith Rongeur Down, 4 x 10
Surgical Direct, Inc.
SD92276403
In Commercial Distribution

  • B382SD922764030 ()
SD92276403

  • Orthopaedic joint/limb rongeur
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