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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TLIF TRIAL 11 X 28 X 9MM -5°
NEXT ORTHOSURGICAL, INC.
CACZ001009
In Commercial Distribution

  • 00840314122117 ()

  • Width: 11 Millimeter
  • Length: 28 Millimeter
  • Height: 9 Millimeter
  • Angle: 5 degree
CACZ001009

  • Spinal implant trial
TLIF TRIAL 11 X 28 X 8MM -5°
NEXT ORTHOSURGICAL, INC.
CACZ001008
In Commercial Distribution

  • 00840314122100 ()

  • Width: 11 Millimeter
  • Length: 28 Millimeter
  • Height: 8 Millimeter
  • Angle: 5 degree
CACZ001008

  • Spinal implant trial
TLIF TRIAL 11 X 28 X 7MM -5°
NEXT ORTHOSURGICAL, INC.
CACZ001007
In Commercial Distribution

  • 00840314122094 ()

  • Width: 11 Millimeter
  • Length: 28 Millimeter
  • Height: 7 Millimeter
  • Angle: 5 degree
CACZ001007

  • Spinal implant trial
RFS™ Screw Cannulated 3.5 x 28 mm
Bioretec Oy
RFS-C3528
Not in Commercial Distribution

  • E302RFSC35289 ()

  • Width: 3.5 Millimeter
  • Length: 28 Millimeter
RFS-C3528

  • Bioabsorbable orthopaedic bone screw
WALTHER Male Urethral Sound, Ø 28 FR, 11"
BR Surgical, LLC
BR66-29128
In Commercial Distribution

  • 00840183511982 ()
BR66-29128

  • Urethral sound, reusable
WALTHER Female Urethral Dilator, Ø 28 FR, 5"
BR Surgical, LLC
BR66-28128
In Commercial Distribution

  • 00840183502393 ()
BR66-28128

  • Urethral dilator, reusable
PKGD: O2 REG 1/2-8 LPM/CGA 870
Western Enterprises
OPA-840
In Commercial Distribution

  • B929OPA8400 ()
OPA-840

  • Non-fixed medical gas cylinder regulator
Open-Open Poly MIS Revision Connector, 15mm x 28°
ALPHATEC SPINE, INC.
15450-15-28
In Commercial Distribution

  • 00190376542652 ()


  • Bone-screw internal spinal fixation system connector
Length 28 cm, Catheter Gauge 8 FR/CH.
Coloplast A/S
BCCJ85
In Commercial Distribution

  • 03600040988459 ()
  • 03600040988442 ()
  • 03600040988466 ()

  • Length: 28 Centimeter
  • Catheter Gauge: 8 French
BCCJ85

  • Urological surgical procedure kit, non-medicated, single-use
Flexitron Transfer Tube Set for 6F Flexibles (28)
Nucletron B.V.
137167-03
In Commercial Distribution

  • 08717213028005 ()


  • Brachytherapy system remote afterloading source transfer tube
16 mm CORE ENDPLATE, RND 28 mm 10°
ALPHATEC SPINE, INC.
153-16-R-280010-S
In Commercial Distribution

  • 00190376518817 ()


  • Vertebral body prosthesis
16 mm CORE ENDPLATE, RND 28 mm 5°
ALPHATEC SPINE, INC.
153-16-R-280005-S
In Commercial Distribution

  • 00190376518800 ()


  • Vertebral body prosthesis
16 mm CORE ENDPLATE, RND 28 mm 0°
ALPHATEC SPINE, INC.
153-16-R-280000-S
In Commercial Distribution

  • 00190376518794 ()


  • Vertebral body prosthesis
12 mm CORE ENDPLATE, RND 28 mm 10°
ALPHATEC SPINE, INC.
153-12-R-280010-S
In Commercial Distribution

  • 00190376518626 ()

  • Outer Diameter: 28 Millimeter
  • Angle: 10 degree


  • Vertebral body prosthesis
12 mm CORE ENDPLATE, RND 28 mm 7°
ALPHATEC SPINE, INC.
153-12-R-280007-S
In Commercial Distribution

  • 00190376518619 ()

  • Angle: 7 degree
  • Outer Diameter: 28 Millimeter


  • Vertebral body prosthesis
12 mm CORE ENDPLATE, RND 28 mm 5°
ALPHATEC SPINE, INC.
153-12-R-280005-S
In Commercial Distribution

  • 00190376518602 ()

  • Angle: 5 degree
  • Outer Diameter: 28 Millimeter


  • Vertebral body prosthesis
12 mm CORE ENDPLATE, RND 28 mm 0°
ALPHATEC SPINE, INC.
153-12-R-280000-S
In Commercial Distribution

  • 00190376518596 ()

  • Outer Diameter: 28 Millimeter


  • Vertebral body prosthesis
Length 28 cm, Catheter Gauge 7 FR/CH.
Coloplast A/S
BCCJ75
In Commercial Distribution

  • 03600040988367 ()
  • 03600040988350 ()
  • 03600040988374 ()

  • Length: 28 Centimeter
  • Catheter Gauge: 7 French
BCCJ75

  • Urological surgical procedure kit, non-medicated, single-use
Length 28 cm, Catheter Gauge 8 FR/CH.
Coloplast A/S
BCCU85
In Commercial Distribution

  • 03600040988275 ()
  • 03600040988268 ()
  • 03600040988282 ()

  • Length: 28 Centimeter
  • Catheter Gauge: 8 French
BCCU85

  • Urological surgical procedure kit, non-medicated, single-use
Length 28 cm, Catheter Gauge 7 FR/CH.
Coloplast A/S
BCCU75
In Commercial Distribution

  • 03600040988183 ()
  • 03600040988176 ()
  • 03600040988190 ()

  • Length: 28 Centimeter
  • Catheter Gauge: 7 French
BCCU75

  • Urological surgical procedure kit, non-medicated, single-use
RODLINK B TYPE, STROKE 28~32mm, Length 39mm
Corentec Co., Ltd
SP.C52.0028
In Commercial Distribution

  • 08800017242187 ()


  • Bone-screw internal spinal fixation system connector
Red. head screw Ø 2.7 L.28 mm
INTRAUMA SPA
120.2728
In Commercial Distribution

  • 08056693002533 ()

  • Length: 28 Millimeter
120.2728

  • Orthopaedic bone screw (non-sliding)
Autolocking screw Ø 2.5 mm L.28 mm
INTRAUMA SPA
120.2528
In Commercial Distribution

  • 08056693002359 ()

  • Length: 28 Millimeter
120.2528

  • Orthopaedic bone screw (non-sliding)
12/14 Femoral Head Trial 28+9 Primaloc
Ortho Development Corporation
238-2809P
In Commercial Distribution

  • 00822409084128 ()

  • Outer Diameter: 28 Millimeter


  • Femoral head prosthesis trial
12/14 Femoral Head Trial 28+6 Primaloc
Ortho Development Corporation
238-2806P
In Commercial Distribution

  • 00822409084104 ()

  • Outer Diameter: 28 Millimeter


  • Femoral head prosthesis trial
12/14 Femoral Head Trial 28+3 Primaloc
Ortho Development Corporation
238-2803P
In Commercial Distribution

  • 00822409084081 ()

  • Outer Diameter: 28 Millimeter


  • Femoral head prosthesis trial
12/14 Femoral Head Trial 28+0 Primaloc
Ortho Development Corporation
238-2800P
In Commercial Distribution

  • 00822409084067 ()

  • Outer Diameter: 28 Millimeter


  • Femoral head prosthesis trial
LEOPARD VBR SPINAL SYSTEM PARALLEL 28 x 13mm
Medos International Sàrl
186449113
Not in Commercial Distribution

  • 10705034119465 ()
186449113

  • Polymeric spinal interbody fusion cage
LEOPARD VBR SPINAL SYSTEM PARALLEL 28 x 14mm
Medos International Sàrl
186449114
Not in Commercial Distribution

  • 10705034119472 ()
186449114

  • Polymeric spinal interbody fusion cage
LEOPARD VBR SPINAL SYSTEM PARALLEL 28 x 12mm
Medos International Sàrl
186449112
Not in Commercial Distribution

  • 10705034119458 ()
186449112

  • Polymeric spinal interbody fusion cage
LEOPARD VBR SPINAL SYSTEM PARALLEL 28 x 11mm
Medos International Sàrl
186449111
Not in Commercial Distribution

  • 10705034119441 ()
186449111

  • Polymeric spinal interbody fusion cage
LEOPARD VBR SPINAL SYSTEM PARALLEL 28 x 10mm
Medos International Sàrl
186449110
Not in Commercial Distribution

  • 10705034119434 ()
186449110

  • Polymeric spinal interbody fusion cage
LEOPARD VBR SPINAL SYSTEM PARALLEL 28 x 9mm
Medos International Sàrl
186449109
Not in Commercial Distribution

  • 10705034119427 ()
186449109

  • Polymeric spinal interbody fusion cage
LEOPARD VBR SPINAL SYSTEM PARALLEL 28 x 8mm
Medos International Sàrl
186449108
Not in Commercial Distribution

  • 10705034119410 ()
186449108

  • Polymeric spinal interbody fusion cage
LEOPARD VBR SPINAL SYSTEM PARALLEL 28 x 7mm
Medos International Sàrl
186449107
Not in Commercial Distribution

  • 10705034119403 ()
186449107

  • Polymeric spinal interbody fusion cage
UROPASS EXCH 6.0 x 28 CM, WO/G
Gyrus ACMI, LLC
5456028
Not in Commercial Distribution

  • 00821925006904 ()


  • Polymeric ureteral stent
7.0FR(2.3mm) X 28 cm URO-GUIDE URETERAL STENT
Gyrus ACMI, LLC
5497028
In Commercial Distribution

  • 00821925006744 ()


  • Polymeric ureteral stent
8.5FR (2.81mm) X 28 cm URO-GUIDE URETERAL STENT
Gyrus ACMI, LLC
5498528
In Commercial Distribution

  • 00821925003705 ()


  • Polymeric ureteral stent
6.0FR (2.0mm) X 28 cm URO-GUIDE URETERAL STENT
Gyrus ACMI, LLC
5496028
In Commercial Distribution

  • 00821925002609 ()


  • Polymeric ureteral stent
UROPASS EXCH 8.5 x 28 CM WO/GW
Gyrus ACMI, LLC
5458528
Not in Commercial Distribution

  • 00821925001558 ()


  • Polymeric ureteral stent
U BY KOTEX SUPRPREM UTXHVY OVRNTWNG PAD 28
KIMBERLY-CLARK GLOBAL SALES, INC.
Pad
Not in Commercial Distribution

  • 10036000544487 ()
  • 00036000544480 ()
  • 00036000536768 ()


  • Menstrual pad, unscented
U BY KOTEX PREM ULTRATHN OVRNTWNG PAD 28
KIMBERLY-CLARK GLOBAL SALES, INC.
Pad
Not in Commercial Distribution

  • 10036000536321 ()
  • 00036000536324 ()
  • 00036000536768 ()


  • Menstrual pad, unscented
U BY KOTEX SUPRPREM ULTRATHN HVYWNG PAD 28
KIMBERLY-CLARK GLOBAL SALES, INC.
Pad
Not in Commercial Distribution

  • 10036000534792 ()
  • 00036000534795 ()
  • 00036000536768 ()


  • Menstrual pad, unscented
Cross-Linked PE Insert Flat Diam. 28 Gr. D
ADLER ORTHO SPA
Acetabular Insert
In Commercial Distribution

  • 08050507130184 ()

  • Diameter 28 Group D
0882008

  • Non-constrained polyethylene acetabular liner
Cross-Linked PE Insert Flat Diam. 28 Gr. C
ADLER ORTHO SPA
Acetabular Insert
In Commercial Distribution

  • 08050507130177 ()

  • Diameter 28 Group C
0882006

  • Non-constrained polyethylene acetabular liner
Cross-Linked PE Insert Flat Diam. 28 Gr. B
ADLER ORTHO SPA
Acetabular Insert
In Commercial Distribution

  • 08050507130160 ()

  • Diameter 28 Group B
0882004

  • Non-constrained polyethylene acetabular liner
Cross-Linked PE Insert Flat Diam. 28 Gr. A
ADLER ORTHO SPA
Acetabular Insert
In Commercial Distribution

  • 08050507130153 ()

  • Diameter 28 Group A
0882002

  • Non-constrained polyethylene acetabular liner
WEB I MOL BANDS G8424-17+G2820-00 LL 28
LEONE SPA
E8971-28
In Commercial Distribution

  • 08033707085409 ()
E8971-28

  • Orthodontic metal band
WEB I MOL BANDS G8424-16+G2820-00 LR 28
LEONE SPA
E8961-28
In Commercial Distribution

  • 08033707085058 ()
E8961-28

  • Orthodontic metal band
WEB I MOL BANDS G8421-17+G2820-00 LL 28
LEONE SPA
E8970-28
In Commercial Distribution

  • 08033707036425 ()
E8970-28

  • Orthodontic metal band
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