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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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ACRYSOF® IQ RESTOR ® Monoflex® - 00380652263214

AcrySof(R) IQ ReSTOR(R) APODIZED DIFFRACTIVEMULTIPIECE STERILE PCL(IOL/PC) 13.0mm LENGTH 6.0mm OPTIC 10-DEGREE Monoflex(TM*) HAPTICS.*REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
MN6AD1
In Commercial Distribution

  • 00380652263214 ()

  • Diopter 28


  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® ACRYSERT® - 00380652249379

AcrySof(R) IQ ASPHERIC IOL, SP ACRYLIC FOLDABLELENS, w/AcrySert(R) DELIVERY SYSTEM, UV w/BLUELIGHT FILTER, 13.0mm LENGTH, 6.0mm ANTERIORASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN6CWS
Not in Commercial Distribution

  • 00380652249379 ()

  • Diopter 28
SN6CWS.280

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® IQ RESTOR® - 00380652241397

AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC.
Alcon Laboratories, Inc.
SN6AD1
Not in Commercial Distribution

  • 00380652241397 ()

  • Diopter 28


  • Posterior-chamber intraocular lens, pseudophakic

Alcon Single-Piece PMMA Slant - 00380650702661

SINGLE-PIECE PMMA STERILE PCL (IOL/PC),12.5mm LENGTH, 6.0mm BICONVEX OPTIC,5-DEGREE "SLANT"(TM*) HAPTICS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
MZ60BD
Not in Commercial Distribution

  • 00380650702661 ()

  • Diopter 28
MZ60BD.280

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652275026

AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 3.75 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT6
Not in Commercial Distribution

  • 00380652275026 ()

  • Diopter 28
SN6AT6U280

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652251150

AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 3.00 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT5
In Commercial Distribution

  • 00380652251150 ()

  • Diopter 28
SN6AT5.280

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652250580

AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 2.25 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT4
In Commercial Distribution

  • 00380652250580 ()

  • Diopter 28
SN6AT4.280

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652250054

AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 1.50 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT3
In Commercial Distribution

  • 00380652250054 ()

  • Diopter 28
SN6AT3.280

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® IQ RESTOR® - 00380652241847

AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC.
Alcon Laboratories, Inc.
SN6AD1
Not in Commercial Distribution

  • 00380652241847 ()

  • Diopter 28


  • Posterior-chamber intraocular lens, pseudophakic

RUSCH - 24026704015058

Nasopharyngeal airway
TELEFLEX INCORPORATED
IPN042342
In Commercial Distribution

  • 44026704015052 ()
  • 24026704015058 ()
  • 04026704015054 ()

  • Catheter Gauge: 28 French
  • Ch. 28
125200-000280

  • Nasopharyngeal airway, reusable

Biomet® Knee System - 00887868241673

No Description
Biomet Orthopedics, LLC
CP102886
In Commercial Distribution

  • 00887868241673 ()

  • 28 mm
CP102886

  • Polyethylene patella prosthesis

Vanguard Complete Knee System - 00887868241215

No Description
Biomet Orthopedics, LLC
SSI004320
In Commercial Distribution

  • 00887868241215 ()

  • Size 28
SSI004320

  • Patella prosthesis trial

THP™ Hip Fracture Plating System - 00887868165993

No Description
Biomet Orthopedics, LLC
14-455528
In Commercial Distribution

  • 00887868165993 ()

  • 28 mm
14-455528

  • Orthopaedic bone screw, non-bioabsorbable, sterile

THP™ Hip Fracture Plating System - 00887868165689

No Description
Biomet Orthopedics, LLC
14-454528
In Commercial Distribution

  • 00887868165689 ()

  • 28 mm
14-454528

  • Orthopaedic bone screw, non-bioabsorbable, sterile

RINGLOC® HIP SYSTEM - 00887868230066

No Description
Biomet Orthopedics, LLC
105428
In Commercial Distribution

  • 00887868230066 ()

  • 28 SIZE
105428

  • Acetabular shell

N.A. - J011480100000

Cross tube, horizontal: 0.56 x 0.70 mm / 22 x 28; vertical: 0.56 x 0.70 mm / 22 x 28
DENTAURUM GmbH & Co.KG
480-100-00
In Commercial Distribution

  • J011480100000 ()
  • J011480100001 ()


  • Orthodontic tube

RingLoc® Acetabular System - 00880304312098

No Description
Biomet Orthopedics, LLC
31-433508
In Commercial Distribution

  • 00880304312098 ()

  • 10° Hi-Wall 28 mm Size 28
31-433508

  • Acetabulum prosthesis trial, prefabricated, reusable

RingLoc® Acetabular System - 00880304310810

No Description
Biomet Orthopedics, LLC
31-423508
In Commercial Distribution

  • 00880304310810 ()

  • 10° 28 mm Liner Size 28
31-423508

  • Acetabulum prosthesis trial, prefabricated, reusable

STANDARD FACE PROVISIONAL - 00880304301412

No Description
Biomet Orthopedics, LLC
31-105888
In Commercial Distribution

  • 00880304301412 ()

  • SIZE 28, ACETABULAR LINER 28 MM
31-105888

  • Acetabulum prosthesis trial, prefabricated, reusable

RingLoc® + - 00887868502279

No Description
Biomet Orthopedics, LLC
33-116828
In Commercial Distribution

  • 00887868502279 ()

  • Size 28 X 28 mm I.D.
33-116828

  • Acetabulum prosthesis trial, prefabricated, reusable

RingLoc®+ Max-Rom™ - 00887868502040

No Description
Biomet Orthopedics, LLC
33-115828
In Commercial Distribution

  • 00887868502040 ()

  • Size 28 X 28 mm I.D.
33-115828

  • Acetabulum prosthesis trial, prefabricated, reusable

RingLoc® Acetabular Series - 00887868258749

No Description
Biomet Orthopedics, LLC
31-433708
In Commercial Distribution

  • 00887868258749 ()

  • Hi-Wall +5 28 mm Size 28
31-433708

  • Acetabulum prosthesis trial, prefabricated, reusable

CATH-MATE II X-LONG STRAP 28" - 00610570187379

No Description
Bird & Cronin, LLC
08148213
In Commercial Distribution

  • 00610570187379 ()
  • 00610570127559 ()


  • Urinary catheter holder

28" COMFOR KNEE IMMOB UNIV - 00610570010554

No Description
Bird & Cronin, LLC
08142669
In Commercial Distribution

  • 00610570010554 ()


  • Knee sling

SONICflex micro Tip No. 28 - EKAV057167410

This is a medical device.This is a medical device.
KaVo Dental GmbH
0.571.6741
In Commercial Distribution

  • EKAV057167410 ()
micro Tip No 28

  • Ultrasonic dental scaling/debridement system

28 MM CEMENTED CUP SLEEVE - 00880304371385

No Description
Biomet Orthopedics, LLC
423537
In Commercial Distribution

  • 00880304371385 ()
423537

  • Orthopaedic inorganic implant inserter/extractor, reusable

1-Level Cervical Plates, 28 mm - M739CP300280

No Description
CAPTIVA SPINE, INC.
CP30028
In Commercial Distribution

  • M739CP300280 ()


  • Spinal fixation plate, non-bioabsorbable

TLIF Straight, 28 x 16mm - M739PS28160

No Description
CAPTIVA SPINE, INC.
PS2816
In Commercial Distribution

  • M739PS28160 ()


  • Polymeric spinal interbody fusion cage

TLIF Straight, 28 x 15mm - M739PS28150

No Description
CAPTIVA SPINE, INC.
PS2815
In Commercial Distribution

  • M739PS28150 ()


  • Polymeric spinal interbody fusion cage

TLIF Straight, 28 x 14mm - M739PS28140

No Description
CAPTIVA SPINE, INC.
PS2814
In Commercial Distribution

  • M739PS28140 ()


  • Polymeric spinal interbody fusion cage
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