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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Mission Urinalysis Reagent Strips (GLU)
Acon Laboratories, Inc.
U031-011
In Commercial Distribution

  • 00682607000357 ()
  • 00682607000715 ()


  • Urine glucose IVD, kit, rapid colorimetric, clinical
Mission Urinalysis Reagent Strips (PH)
Acon Laboratories, Inc.
U031-011
In Commercial Distribution

  • 00682607000340 ()
  • 00682607000708 ()


  • Urine pH IVD, kit, rapid colorimetric, clinical
No Description
Biomet Orthopedics, LLC
151012
In Commercial Distribution

  • 00880304009875 ()

  • 14 MM 71/75 MM
151012

  • Tibial insert
Blood Glucose Test Strips, vial of 50 strips
Acon Laboratories, Inc.
G135-10L
In Commercial Distribution

  • 00682607000296 ()
  • 00682607000128 ()


  • Glucose monitoring system IVD, point-of-care
  • Glucose monitoring system IVD, home-use
No Description
Biomet Orthopedics, LLC
135254
In Commercial Distribution

  • 00880304009851 ()

  • 54 MM 24 LINER SIZE
135254

  • Acetabular shell
No Description
Biomet Orthopedics, LLC
135246
In Commercial Distribution

  • 00880304009844 ()

  • 46 MM 22 LINER SIZE
135246

  • Acetabular shell
No Description
Biomet Orthopedics, LLC
135268
In Commercial Distribution

  • 00880304009837 ()

  • 68 MM 27 LINER SIZE
135268

  • Acetabular shell
No Description
Biomet Orthopedics, LLC
135270
In Commercial Distribution

  • 00880304009820 ()

  • 70 MM 28 LINER SIZE
135270

  • Acetabular shell
No Description
Biomet Orthopedics, LLC
135266
In Commercial Distribution

  • 00880304009813 ()

  • 66 MM 27 LINER SIZE
135266

  • Acetabular shell
Blood Glucose Test Strips, vial of 50 strips
Acon Laboratories, Inc.
G135-10D
In Commercial Distribution

  • 00682607000098 ()
  • 00682607000111 ()


  • Glucose monitoring system IVD, point-of-care
  • Glucose monitoring system IVD, home-use
No Description
Biomet Orthopedics, LLC
135262
In Commercial Distribution

  • 00880304009790 ()

  • 62 MM 26 LINER SIZE
135262

  • Acetabular shell
No Description
Biomet Orthopedics, LLC
135260
In Commercial Distribution

  • 00880304009783 ()

  • 60 MM 25 LINER SIZE
135260

  • Acetabular shell
No Description
Biomet Orthopedics, LLC
135258
In Commercial Distribution

  • 00880304009776 ()

  • 58 MM 25 LINER SIZE
135258

  • Acetabular shell
No Description
Biomet Orthopedics, LLC
135248
In Commercial Distribution

  • 00880304009769 ()

  • 48 MM 22 LINER SIZE
135248

  • Acetabular shell
No Description
Biomet Orthopedics, LLC
11-108277
In Commercial Distribution

  • 00880304009752 ()

  • 17 SIZE 250 MM
11-108277

  • Acetabular shell
No Description
Biomet Orthopedics, LLC
475675
In Commercial Distribution

  • 00880304009745 ()
475675

  • Bone file/rasp, manual, reusable
No Description
Biomet Orthopedics, LLC
141205
In Commercial Distribution

  • 00880304009738 ()
141205

  • Uncoated knee tibia prosthesis, metallic
No Description
Biomet Orthopedics, LLC
151014
In Commercial Distribution

  • 00880304009721 ()

  • 18 MM 71/75 MM
151014

  • Tibial insert
No Description
Biomet Orthopedics, LLC
151009
In Commercial Distribution

  • 00880304009714 ()

  • 18 MM 63/67 MM
151009

  • Tibial insert
DRIVER 9098061 HEX STANDARD
MEDTRONIC SOFAMOR DANEK, INC.
9098061
In Commercial Distribution

  • 00681490993616 ()


  • Surgical screwdriver, reusable
No Description
Biomet Orthopedics, LLC
11-113800
In Commercial Distribution

  • 00880304009639 ()

  • 7 MM 190 MM
11-113800

  • Coated shoulder humeral stem prosthesis
No Description
Biomet Orthopedics, LLC
114022
In Commercial Distribution

  • 00880304009622 ()

  • 40MM Ø 15MM HEIGHT
114022

  • Stem-fixed metallic humeral head prosthesis
DRILL BIT 9098040 FACET SCREW
MEDTRONIC SOFAMOR DANEK, INC.
9098040
In Commercial Distribution

  • 00681490993548 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
No Description
Biomet Orthopedics, LLC
498003
In Commercial Distribution

  • 00880304009608 ()
498003

  • Orthopaedic wire crimper
2MM DOWNBIT PITUITARY W/TEETH
MEDTRONIC SOFAMOR DANEK, INC.
X9560569
In Commercial Distribution

  • 00681490993258 ()


  • Orthopaedic joint/limb rongeur
MICROPITUITARY X9560567 2MM UPBTNG TEETH
MEDTRONIC SOFAMOR DANEK, INC.
X9560567
In Commercial Distribution

  • 00681490993241 ()


  • Orthopaedic joint/limb rongeur
No Description
Biomet Orthopedics, LLC
11-146556
In Commercial Distribution

  • 00880304009561 ()

  • 16MM 71/75MM
11-146556

  • Tibial insert
2MM UPBITING PITUITARY W/TEETH
MEDTRONIC SOFAMOR DANEK, INC.
X9560564
In Commercial Distribution

  • 00681490993210 ()


  • Orthopaedic joint/limb rongeur
No Description
Biomet Orthopedics, LLC
433756
In Commercial Distribution

  • 00880304009523 ()
433756

  • Acetabulum prosthesis trial, prefabricated, reusable
2MM BAYONET KERRISON, 90
MEDTRONIC SOFAMOR DANEK, INC.
X9560603
In Commercial Distribution

  • 00681490993180 ()


  • Bone curette, reusable
No Description
Biomet Orthopedics, LLC
433764
In Commercial Distribution

  • 00880304009509 ()
433764

  • Acetabulum prosthesis trial, prefabricated, reusable
1MM BAYONET KERRISON, 90
MEDTRONIC SOFAMOR DANEK, INC.
X9560601
In Commercial Distribution

  • 00681490993166 ()


  • Bone curette, reusable
No Description
Biomet Orthopedics, LLC
11-103207
In Commercial Distribution

  • 00880304009165 ()

  • 13.5 SIZE 147 MM TYPE1 TAPER
11-103207

  • Coated hip femur prosthesis, modular
CRUCIFORM TAMP
MEDTRONIC SOFAMOR DANEK, INC.
X0101017
In Commercial Distribution

  • 00681490993142 ()


  • Surgical tamp, reusable
CURVED RIB RESECTOR
MEDTRONIC SOFAMOR DANEK, INC.
X1200010
In Commercial Distribution

  • 00681490993111 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Biomet Orthopedics, LLC
11-146736
In Commercial Distribution

  • 00880304009141 ()

  • 16MM 63/67MM
11-146736

  • Tibial insert
No Description
Biomet Orthopedics, LLC
31-380355
In Commercial Distribution

  • 00880304009127 ()

  • PLUS 10.5MM
31-380355

  • Femoral head prosthesis trial
No Description
Biomet Orthopedics, LLC
11-165208
In Commercial Distribution

  • 00880304009110 ()

  • 42MM OUTER Ø 28MM INNER Ø
11-165208

  • Bipolar femoral head outer component, hemiarthroplasty
No Description
Biomet Orthopedics, LLC
145112
In Commercial Distribution

  • 00880304009097 ()

  • 65MM
145112

  • Uncoated knee femur prosthesis, metallic
No Description
Biomet Orthopedics, LLC
11-165216
In Commercial Distribution

  • 00880304009080 ()

  • 46MM OUTER Ø 28MM INNER Ø
11-165216

  • Bipolar femoral head outer component, hemiarthroplasty
No Description
Biomet Orthopedics, LLC
113760
In Commercial Distribution

  • 00880304009073 ()

  • 40MM HEAD Ø 15MM HEIGHT
113760

  • Stem-fixed metallic humeral head prosthesis
No Description
Biomet Orthopedics, LLC
430056
In Commercial Distribution

  • 00880304009066 ()
430056

  • Orthopaedic osteotome blade, reusable
No Description
Biomet Orthopedics, LLC
114813
In Commercial Distribution

  • 00880304009059 ()

  • 3 MM 75MM LENGTH
114813

  • Metal-backed elbow ulna prosthesis
No Description
Biomet Orthopedics, LLC
11-135162
In Commercial Distribution

  • 00880304009042 ()

  • 13 SIZE 165 MM
11-135162

  • Acetabular shell
No Description
Biomet Orthopedics, LLC
21-108395
In Commercial Distribution

  • 00880304009035 ()

  • 3 SIZE TYPE I TAPER
21-108395

  • Coated hip femur prosthesis, modular
No Description
Biomet Sports Medicine, LLC
909694
In Commercial Distribution

  • 00880304009028 ()

  • 11 MM 20 MM ROUND HEAD
909694

  • Ligament bone anchor
No Description
Biomet Orthopedics, LLC
11-146764
In Commercial Distribution

  • 00880304009004 ()

  • 24MM 71/75MM
11-146764

  • Tibial insert
No Description
Biomet Orthopedics, LLC
31-473625
In Commercial Distribution

  • 00880304008991 ()
31-473625

  • Surgical drill guide, reusable
No Description
Biomet Orthopedics, LLC
31-476946
In Commercial Distribution

  • 00880304008984 ()
31-476946

  • Orthopaedic implant driver
No Description
Biomet Orthopedics, LLC
32-341616
In Commercial Distribution

  • 00880304008953 ()

  • 16MM X 80MM
32-341616

  • Knee tibia prosthesis trial, reusable
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