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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EP Varnish Bubblegum .25 ml (35)
PREMIER DENTAL PRODUCTS COMPANY
9007542
In Commercial Distribution

  • 10348783005612 ()
  • 00348783005615 ()


  • Dental coating, tooth-desensitizing, professional
EP Varnish Bubblegum .40 ml (35)
PREMIER DENTAL PRODUCTS COMPANY
9007541
In Commercial Distribution

  • 10348783005605 ()
  • 00348783005608 ()


  • Dental coating, tooth-desensitizing, professional
Premier X5 Ring Universal- Qty 35
PREMIER DENTAL PRODUCTS COMPANY
9061190
In Commercial Distribution

  • 00348783004687 ()


  • Dental matrix band retainer
35 w/ Suture Push-In Suture Anchor
PARCUS MEDICAL LLC
11339
In Commercial Distribution

  • M685113390 ()

  • Outer Diameter: 3.5 Millimeter
11339

  • Tendon/ligament bone anchor, non-bioabsorbable
35 w/ Suture Push-In Suture Anchor
PARCUS MEDICAL LLC
10323T
In Commercial Distribution

  • M68510323T0 ()

  • Outer Diameter: 3.5 Millimeter
10323T

  • Tendon/ligament bone anchor, non-bioabsorbable
35 w/ Suture Push-In Suture Anchor
PARCUS MEDICAL LLC
10323T
In Commercial Distribution

  • M68510323T1 ()
  • M68510323T0 ()

  • Outer Diameter: 3.5 Millimeter
10323T

  • Tendon/ligament bone anchor, non-bioabsorbable
Prism Block with handle, 35 Diopter
Optego Vision USA Inc.
936935
In Commercial Distribution

  • 00360843010650 ()


  • Diagnostic ophthalmic prism
REAMERS ENGINE SS 21MM #35 PK6
BENCO DENTAL SUPPLY CO.
4553-477
In Commercial Distribution

  • 00366975030412 ()


  • Manual endodontic file/rasp, reusable
Locking Screw - 4.5 mm x 35
EXTREMITY MEDICAL, LLC
148-45135
In Commercial Distribution

  • 00842078119761 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Non-Locking Screw - 4.5 mm x 35
EXTREMITY MEDICAL, LLC
148-45035
In Commercial Distribution

  • 00842078119709 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Locking Screw - 3.5 mm x 35
EXTREMITY MEDICAL, LLC
148-35135
In Commercial Distribution

  • 00842078119624 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Non-Locking Screw - 3.5 mm x 35
EXTREMITY MEDICAL, LLC
148-35035
In Commercial Distribution

  • 00842078119549 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Cannulated Screw - 4.0 mm x 35
EXTREMITY MEDICAL, LLC
148-40135
In Commercial Distribution

  • 00842078117743 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
4.75 mm Locking Screw x 35
EXTREMITY MEDICAL, LLC
137-47535
In Commercial Distribution

  • 00842078116968 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Scherbak blade 85 x 35 mm
RZ-Medizintechnik GmbH
330-301-002
In Commercial Distribution

  • 04049197264839 ()
330-301-002

  • Vaginal speculum, reusable
PGI Curette, Right Angled 35° Sharp
Nuvasive, Inc.
Z112023-7
In Commercial Distribution

  • 00195377163837 ()


  • Internal spinal fixation procedure kit, reusable
PGI Curette, Left Angled 35° Sharp
Nuvasive, Inc.
Z112023-6
In Commercial Distribution

  • 00195377163752 ()


  • Internal spinal fixation procedure kit, reusable
PRO JUNIOR-EURO 35/36, KIDS 3.5-4.5
MEDI MANUFACTURING, INC.
PIA1835
In Commercial Distribution

  • 04049772346417 ()


  • Orthotic insole, prefabricated, non-antimicrobial
PRO CONTROL-EURO 35/36, M-, W4-5.5
MEDI MANUFACTURING, INC.
PIA1535
In Commercial Distribution

  • 04049772345557 ()


  • Orthotic insole, prefabricated, non-antimicrobial
PRO ACTIVE-E 35/36, M-, W4-5.5
MEDI MANUFACTURING, INC.
PIA0435
In Commercial Distribution

  • 04049772345472 ()


  • Orthotic insole, prefabricated, non-antimicrobial
***DISC*NATURAL - EURO 35, MEN -, WOMEN
MEDI MANUFACTURING, INC.
PIA1235
Not in Commercial Distribution

  • 04049772345328 ()


  • Orthotic insole, prefabricated, non-antimicrobial
PRO BUSINESS PRO-E 35, M-, W4-4.5
MEDI MANUFACTURING, INC.
PIA0935
In Commercial Distribution

  • 04049772344956 ()


  • Orthotic insole, prefabricated, non-antimicrobial
PROTECT. PF PRO-E 35, M-, W4-4.5
MEDI MANUFACTURING, INC.
PIA0635
In Commercial Distribution

  • 04049772344666 ()


  • Orthotic insole, prefabricated, non-antimicrobial
PROTECT. PF-E 35/36, M-, W4-5.5
MEDI MANUFACTURING, INC.
PIA0535
In Commercial Distribution

  • 04049772344529 ()


  • Orthotic insole, prefabricated, non-antimicrobial
Inlay Clip for length 35 mm
MONDEAL Medical Systems GmbH
75-TC3-0677-35
Not in Commercial Distribution

  • 04050435116308 ()
75-TC3-0677-35

  • Device sterilization/disinfection container, reusable
"UHI-3 HIGH FLOW INSUFFLATOR 35 L"
OLYMPUS MEDICAL SYSTEMS CORP.
UHI-3
Not in Commercial Distribution

  • 04953170140280 ()


  • Laparoscopic insufflator
Novel CP, S, 35 mm, PEEK
ALPHATEC SPINE, INC.
64733-035
In Commercial Distribution

  • 00844856016910 ()

  • Height: 35 Millimeter
  • Angle: 5 degree
  • Width: 18 Millimeter
  • Length: 20 Millimeter


  • Vertebral body prosthesis
BROACH BARBD 35 PH BX 144
PREMIER DENTAL PRODUCTS COMPANY
9053633
In Commercial Distribution

  • D6919053633 ()


  • Endodontic broach, serrated, single-use
FILES HEDSTROM PKG 6 25MM 35
PREMIER DENTAL PRODUCTS COMPANY
9053430
In Commercial Distribution

  • D6919053430 ()


  • Manual endodontic file/rasp, reusable
FILES HEDSTROM PKG 6 21MM 35
PREMIER DENTAL PRODUCTS COMPANY
9053405
In Commercial Distribution

  • D6919053405 ()


  • Manual endodontic file/rasp, reusable
WSL REAMERS PKG 6 25MM 35
PREMIER DENTAL PRODUCTS COMPANY
9053037
In Commercial Distribution

  • D6919053037 ()


  • Manual endodontic file/rasp, reusable
EP Varnish Clear-VanillaMint .40 ml (35)
PREMIER DENTAL PRODUCTS COMPANY
9007547
Not in Commercial Distribution

  • D6919007547 ()


  • Dental cavity varnish
EP Varnish Clear-Bubblegum .25 ml (35)
PREMIER DENTAL PRODUCTS COMPANY
9007542
Not in Commercial Distribution

  • D6919007542 ()


  • Dental cavity varnish
EP Varnish Clear-Bubblegum .40 ml (35)
PREMIER DENTAL PRODUCTS COMPANY
9007541
Not in Commercial Distribution

  • D6919007541 ()


  • Dental cavity varnish
FENESTRATED SNAP DRAPE, 35 X 50
MEDLINE INDUSTRIES, INC.
M-09875-005A
In Commercial Distribution

  • 40080196028406 ()
  • 10080196028405 ()
M-09875-005A

  • Patient surgical drape, single-use, non-sterile
FENESTRATED SNAP DRAPE, 35 X 25
MEDLINE INDUSTRIES, INC.
75-1357
In Commercial Distribution

  • 40080196001881 ()
  • 10080196001880 ()
75-1357

  • Patient surgical drape, single-use, non-sterile
ALPEN STERIX RC 35 FG 50PK
COLTENE/WHALEDENT INC
RS100035B
In Commercial Distribution

  • D661RS100035B1 ()
  • D661RS100035B0 ()


  • Carbide dental bur, reusable
ALPEN STERIX RC 35 FG 10PK
COLTENE/WHALEDENT INC
RS100035
In Commercial Distribution

  • D661RS1000351 ()
  • D661RS1000350 ()


  • Carbide dental bur, reusable
6.35mm Straight Rod CP, 35 mm
GLOBUS MEDICAL, INC.
134.535
In Commercial Distribution

  • 00849044058628 ()

  • Outer Diameter: 6.35 Millimeter
  • Length: 35 Millimeter


  • Trans-facet-screw internal spinal fixation system, sterile
6.35mm Straight Rod SS, 35 mm
GLOBUS MEDICAL, INC.
234.535
In Commercial Distribution

  • 00849044062632 ()

  • Outer Diameter: 6.35 Millimeter
  • Length: 35 Millimeter


  • Trans-facet-screw internal spinal fixation system, sterile
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