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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Molar Band UR 28 w/10
ADITEK DO BRASIL S/A
04.01.1280
In Commercial Distribution

  • 07899439209824 ()


  • Orthodontic metal band
Molar Band LL 28 w/10
ADITEK DO BRASIL S/A
04.01.3280
In Commercial Distribution

  • 07899439202016 ()


  • Orthodontic metal band
Molar Band LR 28 w/10
ADITEK DO BRASIL S/A
04.01.4280
In Commercial Distribution

  • 07899439201996 ()


  • Orthodontic metal band
Wave Versalock Rib Plate - 28 Holes
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Wave Versalock Rib Plate - 28 Holes
In Commercial Distribution

  • 07899258663210 ()
344-31S

  • Orthopaedic fixation plate, non-bioabsorbable
Wave Versalock Rib Plate - 28 Holes
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Wave Versalock Rib Plate - 28 Holes
In Commercial Distribution

  • 07899258663036 ()
344-31

  • Orthopaedic fixation plate, non-bioabsorbable
Black n° 28, cavity preparation instrument
Schobell Industrial Ltda
QD.230.28
In Commercial Distribution

  • 07898506843954 ()
QD.230.28

  • Dental restoration carver, resin
Micro Subglottic Scissors, 28 cm, straight
BOSS INSTRUMENTS, LTD., INC.
95-9291
In Commercial Distribution

  • 00888515249868 ()
95-9291

  • General-purpose surgical scissors, reusable
1 LEVEL PLATE LENGTH 28 MM
SpineArt SA
TRY-CP 04 28-S
Not in Commercial Distribution

  • 07640151108137 ()

  • Length: 28 Millimeter
TRY-CP 04 28-S

  • Spinal fixation plate, non-bioabsorbable
KONG-C VBR M, Body, 28 mm
icotec AG
12-80-1328-0
In Commercial Distribution

  • 07640164849744 ()
12-80-1328-0

  • Vertebral body prosthesis
Safety Lancets; 28 Gauge (1.5 mm)
RGH ENTERPRISES
ZPL30028S
In Commercial Distribution

  • 50888499010008 ()
  • 00888499010003 ()
  • 10888499010000 ()
ZPL30028S

  • Blood lancet, single-use
28 Knotless PEEK Suture Anchor, Hip
PARCUS MEDICAL LLC
11321H
In Commercial Distribution

  • 00816342024501 ()


  • Tendon/ligament bone anchor, non-bioabsorbable
ROOMSTAT, MASTER, 3 WAY, 28 SWITCH
Crest Healthcare Supply
5327X4-622
In Commercial Distribution

  • B4845327X46220 ()


  • Nurse call system
Extraction key for 28 Bipolar cup
Medacta International SA
I05.C00.28
In Commercial Distribution

  • 07630971225794 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Hegar Uterine Dilator, 27 x 28
Surgical Direct, Inc.
SD91511328
In Commercial Distribution

  • B382SD915113280 ()
SD91511328

  • Fixed-diameter cervical dilator, reusable
L6L SNAPLINK .022 -28/+2/+2
ORMCO CORPORATION
438-2191
In Commercial Distribution

  • 00889989002669 ()
  • 20889989002663 ()

  • Slot size: .022, Torque: -28, Angulation: +2, Rotation: +2


  • Orthodontic tube
L6R SNAPLINK .022 -28/+2/+2
ORMCO CORPORATION
438-2190
In Commercial Distribution

  • 00889989002652 ()
  • 20889989002656 ()

  • Slot size: .022, Torque: -28, Angulation: +2, Rotation: +2


  • Orthodontic tube
Posterior Smooth Screw, Ø4.0 x 28
NEXXT SPINE, LLC
12-SS-4028
In Commercial Distribution

  • 00889929029527 ()

  • Outer Diameter: 4.0 Millimeter
  • Length: 28 Millimeter


  • Spinal bone screw, non-bioabsorbable
Posterior Smooth Screw, Ø3.5 x 28
NEXXT SPINE, LLC
12-SS-3528
In Commercial Distribution

  • 00889929029411 ()

  • Length: 28 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
VITROS Chemistry Products Calibrator Kit 28
ORTHO-CLINICAL DIAGNOSTICS, INC.
6802323
In Commercial Distribution

  • 10758750002597 ()
6802323

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator
Insignia, ACP, 1 Level, 28 mm
ALPHATEC SPINE, INC.
136-0128
Not in Commercial Distribution

  • 00190376268767 ()


  • Spinal fixation plate, non-bioabsorbable
LOWER LEFT ULTIMAX BAND SIZE 28
ORMCO CORPORATION
460-0128
In Commercial Distribution

  • 00889989050028 ()

  • Band Size 28


  • Orthodontic metal band
LOWER LEFT ULTIMA BAND SIZE 28
ORMCO CORPORATION
460-0028
In Commercial Distribution

  • 00889989049701 ()

  • Band Size 28


  • Orthodontic metal band
LOWER RIGHT ULTIMAX BAND SIZE 28
ORMCO CORPORATION
459-0128
In Commercial Distribution

  • 00889989049442 ()

  • Band Size 28


  • Orthodontic metal band
LOWER RIGHT ULTIMA BAND SIZE 28
ORMCO CORPORATION
459-0028
In Commercial Distribution

  • 00889989049121 ()

  • Band Size 28


  • Orthodontic metal band
UPPER LEFT ULTIMAX BAND SIZE 28
ORMCO CORPORATION
458-0128
In Commercial Distribution

  • 00889989048865 ()

  • Band Size 28


  • Orthodontic metal band
UPPER LEFT ULTIMA BAND SIZE 28
ORMCO CORPORATION
458-0028
In Commercial Distribution

  • 00889989048544 ()

  • Band Size 28


  • Orthodontic metal band
UPPER RIGHT ULTIMAX BAND SIZE 28
ORMCO CORPORATION
457-0128
In Commercial Distribution

  • 00889989048285 ()

  • Band Size 28


  • Orthodontic metal band
UPPER RIGHT ULTIMA BAND SIZE 28
ORMCO CORPORATION
457-0028
In Commercial Distribution

  • 00889989047967 ()

  • Band Size 28


  • Orthodontic metal band
UNIVERSAL UPPER BICUSPID BAND SIZE 28
ORMCO CORPORATION
331-0128
In Commercial Distribution

  • 00889989037180 ()

  • Band Size 28


  • Orthodontic metal band
Liner Trial Neut 28/64-70 +0
Ortho Development Corporation
270-2864
In Commercial Distribution

  • 00822409085538 ()

  • Lumen/Inner Diameter: 70 Millimeter
  • Outer Diameter: 28 Millimeter
  • Height: 64 Millimeter


  • Acetabulum prosthesis trial, prefabricated, reusable
Liner, Trial, Neutral 28/62 +0
Ortho Development Corporation
270-2862
In Commercial Distribution

  • 00822409085521 ()

  • Height: 62 Millimeter
  • Outer Diameter: 28 Millimeter


  • Acetabulum prosthesis trial, prefabricated, reusable
Liner, Trial, Neutral 28/60 +0
Ortho Development Corporation
270-2860
In Commercial Distribution

  • 00822409085514 ()

  • Outer Diameter: 28 Millimeter
  • Height: 60 Millimeter


  • Acetabulum prosthesis trial, prefabricated, reusable
Liner, Trial, Neutral 28/58 +0
Ortho Development Corporation
270-2858
In Commercial Distribution

  • 00822409085507 ()

  • Height: 58 Millimeter
  • Outer Diameter: 28 Millimeter


  • Acetabulum prosthesis trial, prefabricated, reusable
Liner, Trial, Neutral 28/56 +0
Ortho Development Corporation
270-2856
In Commercial Distribution

  • 00822409085491 ()

  • Outer Diameter: 28 Millimeter
  • Height: 56 Millimeter


  • Acetabulum prosthesis trial, prefabricated, reusable
Liner, Trial, Neutral 28/54 +0
Ortho Development Corporation
270-2854
In Commercial Distribution

  • 00822409085484 ()

  • Height: 54 Millimeter
  • Outer Diameter: 28 Millimeter


  • Acetabulum prosthesis trial, prefabricated, reusable
Liner, Trial, Neutral 28/52 +0
Ortho Development Corporation
270-2852
In Commercial Distribution

  • 00822409085477 ()

  • Height: 52 Millimeter
  • Outer Diameter: 28 Millimeter


  • Acetabulum prosthesis trial, prefabricated, reusable
Liner, Trial, Neutral 28/50 +0
Ortho Development Corporation
270-2850
In Commercial Distribution

  • 00822409085460 ()

  • Height: 50 Millimeter
  • Outer Diameter: 28 Millimeter


  • Acetabulum prosthesis trial, prefabricated, reusable
Liner, Trial, Neutral 28/46 +1
Ortho Development Corporation
270-2846
In Commercial Distribution

  • 00822409085446 ()

  • Lumen/Inner Diameter: 1 Millimeter
  • Height: 46 Millimeter
  • Outer Diameter: 28 Millimeter


  • Acetabulum prosthesis trial, prefabricated, reusable
Liner, Trial, Neutral 28/44 +3
Ortho Development Corporation
270-2844
In Commercial Distribution

  • 00822409085439 ()

  • Outer Diameter: 28 Millimeter
  • Height: 44 Millimeter
  • Lumen/Inner Diameter: 3 Millimeter


  • Acetabulum prosthesis trial, prefabricated, reusable
E. coli O 28 : K 73
PRO-LAB, INCORPORATED
PLA540
In Commercial Distribution

  • 00817978025405 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent
Salmonella O Group M O: 28
PRO-LAB, INCORPORATED
PLA033
In Commercial Distribution

  • 00817978020332 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent
Femoral Option Head, Trial Sz 28
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565M141028001 ()
M-1410-2800

  • Femoral head prosthesis trial
Femoral Head, Trial Sz 28 XL
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565M140028041 ()
M-1400-2804

  • Femoral head prosthesis trial
Femoral Head, Trial Sz 28 L
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565M140028031 ()
M-1400-2803

  • Femoral head prosthesis trial
Femoral Head, Trial Sz 28 M
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565M140028021 ()
M-1400-2802

  • Femoral head prosthesis trial
Femoral Head, Trial Sz 28 S
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565M140028011 ()
M-1400-2801

  • Femoral head prosthesis trial
Femoral Head, Ceramic Sz 28 L
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565M132528031 ()
M-1325-2803

  • Ceramic-on-polyethylene total hip prosthesis
Femoral Head, Ceramic Sz 28 M
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565M132528021 ()
M-1325-2802

  • Metal-on-polyethylene total hip prosthesis
Femoral Head, Ceramic Sz 28 S
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565M132528011 ()
M-1325-2801

  • Metal-on-polyethylene total hip prosthesis
Femoral Head, CoCr Sz 28 XL
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565M130028041 ()
M-1300-2804

  • Metal-on-polyethylene total hip prosthesis
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