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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ISQ Measurement Peg
Osstell AB
Osstell SmartPeg Type 15
In Commercial Distribution

  • 09010522000151 ()
  • 09010522001295 ()
100386

  • Dental implant stability resonance frequency analysis peg
Ø4.3mm x L7.5mm, w/ 3mm Shoulder Height, 15˚ Angle, Conical Connection, Wide Platform
Surgikor, LLC
S153WC
In Commercial Distribution

  • D824S153WC0 ()


  • Basket endosteal dental implant, two-piece
Ø3.5mm x L7.5mm, w/ 3mm Shoulder Height, 15˚ Angle, Conical Connection, Regular Platform
Surgikor, LLC
S153RC
In Commercial Distribution

  • D824S153RC0 ()


  • Basket endosteal dental implant, two-piece
Ø4.3mm x L7.5mm, w/ 2mm Shoulder Height, 15˚ Angle, Conical Connection, Wide Platform
Surgikor, LLC
S152WC
In Commercial Distribution

  • D824S152WC0 ()


  • Basket endosteal dental implant, two-piece
Ø3.75mm x L7.5mm, w/ 2mm Shoulder Height, 15˚ Angle, Hex Connection, Regular Platform
Surgikor, LLC
S152RH
In Commercial Distribution

  • D824S152RH0 ()


  • Basket endosteal dental implant, two-piece
Ø4.3mm x L9.0mm, 15˚ Angle, Conical Connection, Wide Platform
Surgikor, LLC
NS159WC
In Commercial Distribution

  • D824NS159WC0 ()


  • Basket endosteal dental implant, two-piece
Ø3.75mm x L9.0mm, 15˚ Angle, Hex Connection, Regular Platform
Surgikor, LLC
NS159RH
In Commercial Distribution

  • D824NS159RH0 ()


  • Basket endosteal dental implant, two-piece
Ø3.5mm x L9.0mm, 15˚ Angle, Conical Connection, Regular Platform
Surgikor, LLC
NS159RC
In Commercial Distribution

  • D824NS159RC0 ()


  • Basket endosteal dental implant, two-piece
Ø3.0mm x L9.0mm, 15˚ Angle, Conical Connection, Narrow Platform
Surgikor, LLC
NS159NC
In Commercial Distribution

  • D824NS159NC0 ()


  • Basket endosteal dental implant, two-piece
Ø4.3mm x L13.0mm, 15˚ Angle, Conical Connection, Wide Platform
Surgikor, LLC
NS1513WC
In Commercial Distribution

  • D824NS1513WC0 ()


  • Basket endosteal dental implant, two-piece
Ø3.75mm x L13.0mm, 15˚ Angle, Hex Connection, Regular Platform
Surgikor, LLC
NS1513RH
In Commercial Distribution

  • D824NS1513RH0 ()


  • Basket endosteal dental implant, two-piece
Ø3.5mm x L13.0mm, 15˚ Angle, Conical Connection, Regular Platform
Surgikor, LLC
NS1513RC
In Commercial Distribution

  • D824NS1513RC0 ()


  • Basket endosteal dental implant, two-piece
Ø3.0mm x L13.0mm, 15˚ Angle, Conical Connection, Narrow Platform
Surgikor, LLC
NS1513NC
In Commercial Distribution

  • D824NS1513NC0 ()


  • Basket endosteal dental implant, two-piece
Ø4.3mm x L11.0mm, 15˚ Angle, Conical Connection, Wide Platform
Surgikor, LLC
NS1511WC
In Commercial Distribution

  • D824NS1511WC0 ()


  • Basket endosteal dental implant, two-piece
Ø3.75mm x L11.0mm, 15˚ Angle, Hex Connection, Regular Platform
Surgikor, LLC
NS1511RH
In Commercial Distribution

  • D824NS1511RH0 ()


  • Basket endosteal dental implant, two-piece
Ø3.5mm x L11.0mm, 15˚ Angle, Conical Connection, Regular Platform
Surgikor, LLC
NS1511RC
In Commercial Distribution

  • D824NS1511RC0 ()


  • Basket endosteal dental implant, two-piece
Ø3.0mm x L11.0mm, 15˚ Angle, Conical Connection, Narrow Platform
Surgikor, LLC
NS1511NC
In Commercial Distribution

  • D824NS1511NC0 ()


  • Basket endosteal dental implant, two-piece
Ø3.75mm x L7.5mm, w/ 3mm Shoulder Height, 15˚ Angle, Hex Connection, Regular Platform
Surgikor, LLC
S153RH
In Commercial Distribution

  • D824S153RH0 ()


  • Basket endosteal dental implant, two-piece
Ø3.0mm x L7.5mm, w/ 3mm Shoulder Height, 15˚ Angle, Conical Connection, Narrow Platform
Surgikor, LLC
S153NC
In Commercial Distribution

  • D824S153NC0 ()


  • Basket endosteal dental implant, two-piece
Ø3.5mm x L7.5mm, w/ 2mm Shoulder Height, 15˚ Angle, Conical Connection, Regular Platform
Surgikor, LLC
S152RC
In Commercial Distribution

  • D824S152RC0 ()


  • Basket endosteal dental implant, two-piece
Ø3.0mm x L7.5mm, w/ 2mm Shoulder Height, 15˚ Angle, Conical Connection, Narrow Platform
Surgikor, LLC
S152NC
In Commercial Distribution

  • D824S152NC0 ()


  • Basket endosteal dental implant, two-piece
Ø4.3mm x L7.5mm, w/ 1mm Shoulder Height, 15˚ Angle, Conical Connection, Wide Platform
Surgikor, LLC
S151WC
In Commercial Distribution

  • D824S151WC0 ()


  • Basket endosteal dental implant, two-piece
Ø3.75mm x L7.5mm, w/ 1mm Shoulder Height, 15˚ Angle, Hex Connection, Regular Platform
Surgikor, LLC
S151RH
In Commercial Distribution

  • D824S151RH0 ()


  • Basket endosteal dental implant, two-piece
Ø3.5mm x L7.5mm, w/ 1mm Shoulder Height, 15˚ Angle, Conical Connection, Regular Platform
Surgikor, LLC
S151RC
In Commercial Distribution

  • D824S151RC0 ()


  • Basket endosteal dental implant, two-piece
Ø3.0mm x L7.5mm, w/ 1mm Shoulder Height, 15˚ Angle, Conical Connection, Narrow Platform
Surgikor, LLC
S151NC
In Commercial Distribution

  • D824S151NC0 ()


  • Basket endosteal dental implant, two-piece
No Description
Biomet Orthopedics, LLC
909871
In Commercial Distribution

  • 00880304412972 ()
909871

  • Orthopaedic osteotome
LITHIUM 15 MMOL/L
UTAK LABORATORIES, INC.
LIT 15 S F BD
In Commercial Distribution

  • B800LIT15SFBD5 ()
  • B800LIT15SFBD0 ()

  • Total Volume: 10 Milliliter
LIT 15 S F BD

  • Multiple-type clinical chemistry analyte profile IVD, control
MIRTAZEPINE 15 NG/ML
UTAK LABORATORIES, INC.
MIRT 15 F WB NMS
In Commercial Distribution

  • B800MIRT15FWBNMS5 ()
  • B800MIRT15FWBNMS0 ()

  • Total Volume: 5 Milliliter
MIRT 15 F WB NMS

  • Multiple-type clinical chemistry analyte profile IVD, control
THIOCYANATE 15 MG/L
UTAK LABORATORIES, INC.
THIOC 15 V2 JH
In Commercial Distribution

  • B800THIOC15V2JH5 ()
  • B800THIOC15V2JH0 ()

  • Total Volume: 5 Milliliter
THIOC 15 V2 JH

  • Multiple-type clinical chemistry analyte profile IVD, control
GEM ChemSTAT PVP1-5, 5 levels x 5 ampoules x 1.8 mL
INSTRUMENTATION LABORATORY COMPANY
00044001515
In Commercial Distribution

  • 08426951293780 ()
  • 18426951293787 ()
00044001515

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
No Description
SEBIA
4134
In Commercial Distribution

  • 03607360041345 ()
4134

  • Protein electrophoresis IVD, kit, electrophoresis
PROTEIN SEPARATION/ FRACTIONALIZATION
SEBIA
4125
In Commercial Distribution

  • 03607360041253 ()
4125

  • Protein electrophoresis IVD, kit, electrophoresis
#15- Teardrop Dissector, Straight
KATALYST SURGICAL LLC
N7115-K
In Commercial Distribution

  • 00840096204773 ()


  • General-purpose surgical spatula
No Description
Lonza Walkersville, Inc.
08-973H
In Commercial Distribution

  • 00840075403029 ()
08-973H

  • Ex vivo cell culture medium
No Description
BISCO INC.
X-81266
In Commercial Distribution

  • D757X812660 ()

  • sixe text
X-81266

  • Dental material mixing nozzle
Compatible with 2.7mm/3.5mm screws, implants for orthopedic bone fixation
FLOWER ORTHOPEDICS CORPORATION
FRP 915
In Commercial Distribution

  • 00840118103565 ()

  • Height: 3.2 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable
Cytokeratin 15 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB66940 ()
BSB 6694

  • Cytokeratin IVD, control
Tinto Cytokeratin 15 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB66900 ()
BSB 6690

  • Cytokeratin IVD, antibody
Tinto Cytokeratin 15 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB66890 ()
BSB 6689

  • Cytokeratin IVD, antibody
Tinto Cytokeratin 15 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB66880 ()
BSB 6688

  • Cytokeratin IVD, antibody
LP15 ACCRY SHIPKIT,AHA
PHYSIO-CONTROL, INC.
41577
In Commercial Distribution

  • 00883873870556 ()
41577-000256

  • Electrocardiographic lead set, reusable
  • General-purpose patient temperature probe, reusable
  • Blood pressure cuff, reusable
LP15 ACCRY SHIPKIT,AHA,S
PHYSIO-CONTROL, INC.
41577
In Commercial Distribution

  • 00883873870549 ()
41577-000257

  • Electrocardiographic lead set, reusable
  • General-purpose patient temperature probe, reusable
  • Blood pressure cuff, reusable
LP15 ACCRY SHIPKIT,AHA,L
PHYSIO-CONTROL, INC.
41577
In Commercial Distribution

  • 00883873870532 ()
41577-000258

  • General-purpose patient temperature probe, reusable
  • Blood pressure cuff, reusable
  • Electrocardiographic lead set, reusable
LP15 ACCRY SHIPKIT,AHA,S
PHYSIO-CONTROL, INC.
41577
In Commercial Distribution

  • 00883873870525 ()
41577-000259

  • Electrocardiographic lead set, reusable
  • General-purpose patient temperature probe, reusable
  • Blood pressure cuff, reusable
LP15 ACCRY SHIPKIT,AHA,S
PHYSIO-CONTROL, INC.
41577
In Commercial Distribution

  • 00883873870501 ()
41577-000261

  • Electrocardiographic lead set, reusable
  • General-purpose patient temperature probe, reusable
  • Blood pressure cuff, reusable
LP15 ACCRY SHIPKIT,AHA,S
PHYSIO-CONTROL, INC.
41577
In Commercial Distribution

  • 00883873870488 ()
41577-000263

  • Electrocardiographic lead set, reusable
  • General-purpose patient temperature probe, reusable
  • Blood pressure cuff, reusable
LP15 ACCRY SHIPKIT,AHA,S
PHYSIO-CONTROL, INC.
41577
In Commercial Distribution

  • 00883873870464 ()
41577-000265

  • Electrocardiographic lead set, reusable
  • General-purpose patient temperature probe, reusable
  • Blood pressure cuff, reusable
LP15 ACCRY SHIPKIT,AHA,S
PHYSIO-CONTROL, INC.
41577
In Commercial Distribution

  • 00883873870440 ()
41577-000267

  • Electrocardiographic lead set, reusable
  • General-purpose patient temperature probe, reusable
  • Blood pressure cuff, reusable
LP15 ACCRY SHIPKIT,AHA,S
PHYSIO-CONTROL, INC.
41577
In Commercial Distribution

  • 00883873870433 ()
41577-000268

  • Electrocardiographic lead set, reusable
  • General-purpose patient temperature probe, reusable
  • Blood pressure cuff, reusable
LP15 ACCRY SHIPKIT,AHA,S
PHYSIO-CONTROL, INC.
41577
In Commercial Distribution

  • 00883873870419 ()
41577-000270

  • Electrocardiographic lead set, reusable
  • General-purpose patient temperature probe, reusable
  • Blood pressure cuff, reusable
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