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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Soprano® 10 Dentine A3 (25 g)
Cendres+Métaux SA
08058762
In Commercial Distribution

  • 07640239932333 ()
08058762

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva bone (25 g)
Cendres+Métaux SA
08058759
In Commercial Distribution

  • 07640239932302 ()
08058759

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva blood (25 g)
Cendres+Métaux SA
08058758
In Commercial Distribution

  • 07640239932296 ()
08058758

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva brown (25 g)
Cendres+Métaux SA
08058756
In Commercial Distribution

  • 07640239932272 ()
08058756

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva violet (25 g)
Cendres+Métaux SA
08058754
In Commercial Distribution

  • 07640239932258 ()
08058754

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva orange (25 g)
Cendres+Métaux SA
08058752
In Commercial Distribution

  • 07640239932234 ()
08058752

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva dark-intense (25 g)
Cendres+Métaux SA
08058749
In Commercial Distribution

  • 07640239932203 ()
08058749

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva dark (25 g)
Cendres+Métaux SA
08058746
In Commercial Distribution

  • 07640239932173 ()
08058746

  • Dental appliance fabrication material, ceramic
Soprano® 10 Gingiva light (25 g)
Cendres+Métaux SA
08058743
In Commercial Distribution

  • 07640239932142 ()
08058743

  • Dental appliance fabrication material, ceramic
Duraguard Sheet .040 White SQUARE 25 pk
DENTSPLY SIRONA ORTHODONTICS INC.
DGSW040X25S
Not in Commercial Distribution

  • D746DGSW040X25S1 ()
  • D746DGSW040X25S0 ()
DGSW040X25S

  • Dental implant x-ray template
DURAGUARD RED .160 (4mm) ROUND 25 PK.
DENTSPLY SIRONA ORTHODONTICS INC.
DGSR160X25R
Not in Commercial Distribution

  • D746DGSR160X25R1 ()
  • D746DGSR160X25R0 ()
DGSR160X25R

  • Dental implant x-ray template
Duraguard Sheet .060 Clear ROUND 25 pk
DENTSPLY SIRONA ORTHODONTICS INC.
DGSC060X25R
Not in Commercial Distribution

  • D746DGSC060X25R1 ()
  • D746DGSC060X25R0 ()
DGSC060X25R

  • Dental implant x-ray template
Band for Premolar U/LR size 25
Dental Morelli Ltda
40.50.025
In Commercial Distribution

  • 07895742197735 ()
40.50.025

  • Orthodontic metal band
Self Drilling Screw Ø 2.0x 25 mm
Neoortho Produtos Ortopédicos S/A.
924.036
In Commercial Distribution

  • 07898624866514 ()


  • Craniofacial bone screw, non-bioabsorbable
#3 Angled Curette .25 Shaft REV 0
Life Instrument Corporation
710-1703-1S-25
In Commercial Distribution

  • M93071017031S250 ()


  • Bone curette, reusable
#1 Angled Curette .25 Shaft REV 0
Life Instrument Corporation
710-1701-1S-25
In Commercial Distribution

  • M93071017011S250 ()


  • Bone curette, reusable
COTTON TIPPED APPLICATORS, 6IN, 25/PKG, STRL
Surgi-Pak, Inc.
13-018
In Commercial Distribution

  • 00817213021858 ()
  • 00817213020554 ()
13-018

  • General-purpose absorbent tip applicator/swab, single-use
COTTON TIPPED APPLICATORS, 3IN, 25/PKG, STRL
Surgi-Pak, Inc.
13-007
In Commercial Distribution

  • 00817213021742 ()
  • 00817213020431 ()
13-007

  • General-purpose absorbent tip applicator/swab, single-use
Flu A & B, Immunochromatographic, 25 Test Kit
POLYMEDCO, INC.
FLU25
In Commercial Distribution

  • 00816917022925 ()


  • Influenza A/B virus neuraminidase activity IVD, kit, rapid ICT, clinical
MOD 1230 W/.25 OD OUTLET ACRYL
HANS RUDOLPH, INC.
1230
Not in Commercial Distribution

  • 00817136023731 ()
P0354

  • Pulmonary function valve
Strep A Test CLIA Waived 25/Box
DEALMED MEDICAL SUPPLIES LLC
788025
In Commercial Distribution

  • 00817415020307 ()
  • 00817415020963 ()
788025

  • Beta-haemolytic Group B Streptococcus antigen IVD, kit, rapid ICT, clinical
Island Dressing 6" x 6" 25/Box
DEALMED MEDICAL SUPPLIES LLC
817415020697
In Commercial Distribution

  • 00817415020697 ()
  • 00817415020529 ()
  • 00817415020093 ()

  • 6" x 6"
783740

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
S-ROM TRIPLE BAND CONE REAMER SIZE 25
DEPUY ORTHOPAEDICS, INC.
2576-02-025
In Commercial Distribution

  • 10603295145370 ()
257602025

  • Medullary canal orthopaedic reamer, rigid
Central peg reamer for baseplate - 25 mm
Medacta International SA
04.01.10.0111
In Commercial Distribution

  • 07630971210479 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Cancellous bone screw Ø 6.5 L 25
Medacta International SA
01.43.0025
In Commercial Distribution

  • 07630971257474 ()


  • Orthopaedic bone screw, non-bioabsorbable, sterile
TINO SUPERFICIAL, BULLET TIP, 3.0MM X 25
SOLTA MEDICAL
810-YFBU3025VXNR
In Commercial Distribution

  • 00816995021087 ()
810-YFBU3025VXNR

  • Liposuction system
NextAR Spine Double Target Mounting 25° (Al)
Medacta International SA
03.57.10.0235
In Commercial Distribution

  • 07630542735882 ()


  • Optical surgical navigation device tracking system
NextAR Spine Double Long Clamp 25° (Al)
Medacta International SA
03.57.10.0227
In Commercial Distribution

  • 07630542735516 ()


  • Optical surgical navigation device tracking system
NextAR Spine Double Long Clamp 25° (Al)
Medacta International SA
03.57.10.0226
In Commercial Distribution

  • 07630542735509 ()


  • Optical surgical navigation device tracking system
NextAR Spine Double Short Clamp 25° (Al)
Medacta International SA
03.57.10.0225
In Commercial Distribution

  • 07630542735493 ()


  • Optical surgical navigation device tracking system
NextAR Spine Single Long Clamp 25° (Al)
Medacta International SA
03.57.10.0224
In Commercial Distribution

  • 07630542735486 ()


  • Optical surgical navigation device tracking system
NextAR Spine Single Short Clamp 25° (Al)
Medacta International SA
03.57.10.0223
In Commercial Distribution

  • 07630542735479 ()


  • Optical surgical navigation device tracking system
ALIF Lag Awl Fixed Handle - Angled 25°
Medacta International SA
03.30.10.2311
In Commercial Distribution

  • 07630542743306 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Klarity Cushion Oval Head Pad 6x8x.25"
Klarity Medical Products, LLC
R550-400M
In Commercial Distribution

  • 00817355028081 ()


  • Indexed-immobilization patient positioning system
Spreaders 111, 25 mm, # 15-40, handle SMG
FKG Dentaire Sàrl
02.111.25.S15.CG
In Commercial Distribution

  • 07640142420330 ()
02.111.25.S15.CG

  • Manual endodontic filling material spreader
Spreaders 111, 25 mm, # 40, handle SMG
FKG Dentaire Sàrl
02.111.25.040.CG
In Commercial Distribution

  • 07640142420323 ()
02.111.25.040.CG

  • Manual endodontic filling material spreader
Spreaders 111, 25 mm, # 35, handle SMG
FKG Dentaire Sàrl
02.111.25.035.CG
In Commercial Distribution

  • 07640142420316 ()
02.111.25.035.CG

  • Manual endodontic filling material spreader
Spreaders 111, 25 mm, # 30, handle SMG
FKG Dentaire Sàrl
02.111.25.030.CG
In Commercial Distribution

  • 07640142420309 ()
02.111.25.030.CG

  • Manual endodontic filling material spreader
Spreaders 111, 25 mm, # 20, handle SMG
FKG Dentaire Sàrl
02.111.25.020.CG
In Commercial Distribution

  • 07640142420286 ()
02.111.25.020.CG

  • Manual endodontic filling material spreader
Spreaders 111, 25 mm, # 15, handle SMG
FKG Dentaire Sàrl
02.111.25.015.CG
In Commercial Distribution

  • 07640142420279 ()
02.111.25.015.CG

  • Manual endodontic filling material spreader
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