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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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QuickChange, 10 Count Pack - 00861859000463

QuickChange for Male Incontinence, 10 Count Pack
Ui Medical, LLC
V 2.0
In Commercial Distribution

  • 00861859000463 ()


  • Incontinence pants liner

Pneumococcus CWPS, 10 mg - 05713106034590

Cell wall polysaccharide
Ssi Diagnostica A/S
3459
In Commercial Distribution

  • 05713106034590 ()
3459

  • Streptococcus pneumoniae total antibody IVD, reagent

EndoPur Endotoxin 10" Filter - 00866318000350

Intended Use: The EndoPur Endotoxin 10” Filter Flat is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid. Indications for Use: The EndoPur Endotoxin 10” Filter Flat is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
NEPHROS, INC.
70-0110
Not in Commercial Distribution

  • 20866318000354 ()
  • 10866318000357 ()
  • 00866318000350 ()


  • Microbial water purification filter, non-sterilizable

PERIOSTEAL ELEVATOR OHL #10 - D9281054360

No Description
W.H. Holden, Inc.
10-5436
In Commercial Distribution

  • D9281054360 ()


  • Periosteal elevator, reusable

RONGEUR #10 FRIEDMAN 14CM - D928100825100

No Description
W.H. Holden, Inc.
10-0825-10
In Commercial Distribution

  • D928100825100 ()


  • Dental rongeur

Origin Size 10 Template - 09348215074739

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-110
In Commercial Distribution

  • 09348215074739 ()


  • Surgical implant template, reusable

Aria Size 10 Template - 09348215073589

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-201-510
In Commercial Distribution

  • 09348215073589 ()


  • Surgical implant template, reusable

Tap Shaft Size 10 - 09348215068363

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
132-112-186
In Commercial Distribution

  • 09348215068363 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable

Cannulated South Drive 10 - 09348215067045

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
132-16-0090
In Commercial Distribution

  • 09348215067045 ()


  • Orthopaedic implant driver

Guide pin 10 mm - 09321502063395

to be used to attach Impression copings to abutments and Abutment replicas when making an impression of the implant site and a cast for the prosthesis
Cochlear Bone Anchored Solutions AB
90794
In Commercial Distribution

  • 09321502063395 ()


  • General external orthopaedic fixation system implantation kit, reusable
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