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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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CEKA & PRECI-LINE ATTACHMENTS - 04260576940407

Preci-Clix Female 2 red 2 Yellow 2 White
Alphadent NV
1234
In Commercial Distribution

  • 04260576940407 ()

  • female
  • Height: 2.65 Millimeter
1234

  • Bar dental precision attachment

gSource - 00840314217653

Scoville Blade solid 2" x 2 1/2"
GSOURCE LLC
gS 40.5520
In Commercial Distribution

  • 00840314217653 ()
gS 40.5520

  • Surgical retractor/retraction system blade, reusable

Brasseler USA - 00887919681472

SG1/2 GRA 1/2 #2 HDL 1P
Peter Brasseler Holdings, LLC
5023350U0
In Commercial Distribution

  • 00887919681472 ()


  • Periodontal curette

Syneture - 10884521165366

Custom Suture Pack,(2) 88863369-51;(3) CL-5-M;(2) CL-905;(2) CLS-843;(6) CS-424;(1) S-318;(2) SM-5678;(2) VP-557-X;(2) VP-581-X;(2) VP-761-X
Covidien LP
US1625
Not in Commercial Distribution

  • 20884521165363 ()
  • 10884521165366 ()


  • Suture kit, medicated

gSource - 00840314213877

Kelly Retr 9 1/2" 2" x 2 1/2" loop hdl
GSOURCE LLC
gS 36.3180
In Commercial Distribution

  • 00840314213877 ()
gS 36.3180

  • Hand-held surgical retractor, reusable

gSource - 00840314217868

Taylor Lam Blade 4 prgs 2 1/2" x 2 1/2"
GSOURCE LLC
gS 40.5750
In Commercial Distribution

  • 00840314217868 ()
gS 40.5750

  • Surgical retractor/retraction system blade, reusable

Syneture - 10884521161597

Custom Suture Pack,(4) CN-825;(2) GLS-322;(2) GS-832;(2) GS-833;(2) S-303;(2) S-304;(3) S-305;(2) S-316;(2) SS-677;(2) VP-521-X;(4) VP-556-X;(4) VP-706-X
Covidien LP
US1596
Not in Commercial Distribution

  • 20884521161594 ()
  • 10884521161597 ()
US1596

  • Suture kit, medicated

Syneture - 10884521582224

Custom Suture Pack, (4) 888864470-81, (2) GLS-322, (2) GLS-832, (2) GS-833, (2) S-303, (2) S-304, (3) S-305, (2) S-316, (2) SS-677, (2) VP-521-X, (4) VP-556-X, (4) VP-706-X
Covidien LP
US1711
Not in Commercial Distribution

  • 20884521582221 ()
  • 10884521582224 ()
US1711

  • Suture kit, medicated

Neuronaute IceCap 2 - 03615220003617

The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours). IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 Ibs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate shall be placed on the head of babies, newborns and premature babies.
BIOSERENITY MEDICAL DEVICES GROUP
1001-01014-UN
In Commercial Distribution

  • 03615220003617 ()


  • Electroencephalographic electrode cap, single-use

4-Lamp 2' Panosol - 00816878020879

No Description
NATIONAL BIOLOGICAL CORPORATION
UVB-241
In Commercial Distribution

  • 00816878020879 ()


  • Ultraviolet phototherapy unit, home-use

ThinkQA Edition 2 - B501THINKQA0200020

Secondary Dose Check for external beam radiation therapy.
DOSISOFT
2.0.2
In Commercial Distribution

  • B501THINKQA0200020 ()


  • Radiation therapy software

ThinkQA Edition 2 - B501THINKQA0200010

Secondary Dose Check for external beam radiation therapy.
DOSISOFT
2.0.1
In Commercial Distribution

  • B501THINKQA0200010 ()
TK2010, TK2020

  • Radiation therapy software

ThinkQA Edition 2 - B501THINKQA0200000

Secondary Dose Check for external beam radiation therapy.
DOSISOFT
2.0.0
In Commercial Distribution

  • B501THINKQA0200000 ()
TK2010, TK2020

  • Radiation therapy software

Damon Clear 2 - 00889989075113

U1L DAMON CLEAR2 .022 +22/+5/0 HIGH TQ
ORMCO CORPORATION
497-6567
In Commercial Distribution

  • 00889989075113 ()
  • 10889989075110 ()

  • Slot Width: .022 Inch


  • Orthodontic bracket, ceramic

Damon Clear 2 - 00889989075106

U1R DAMON CLEAR2 .022 +22/+5/0 HIGH TQ
ORMCO CORPORATION
497-6566
In Commercial Distribution

  • 00889989075106 ()
  • 10889989075103 ()

  • Slot Width: .022 Inch


  • Orthodontic bracket, ceramic

Damon Clear 2 - 00889989075090

U1L DAMON CLEAR2 .022 +2/+5/0 LOW TQ
ORMCO CORPORATION
497-6563
In Commercial Distribution

  • 00889989075090 ()
  • 10889989075097 ()

  • Slot Width: .022 Inch


  • Orthodontic bracket, ceramic

Damon Clear 2 - 00889989075083

U1R .022 +2/+5/0 LOW TQ
ORMCO CORPORATION
497-6562
In Commercial Distribution

  • 00889989075083 ()
  • 10889989075080 ()

  • Slot Width: .022 Inch


  • Orthodontic bracket, ceramic

Ioban™ 2 - 30707387567164

3M™ Ioban™ 2 Antimicrobial Incise Drape 6661EZ
3M COMPANY
6661EZ
In Commercial Distribution

  • 50707387567168 ()
  • 30707387567164 ()
  • 00707387567163 ()
6661EZ

  • Patient surgical drape, single-use

LLD™ #2 - M2045180220

Lead Locking Device (LLD #2)
Spectranetics Corporation
518-022
Not in Commercial Distribution

  • M2045180220 ()
518-022

  • Pacing/defibrillation lead stylet

LLD™ #2 - M2045180190

Lead Locking Device (LLD #2)
Spectranetics Corporation
518-019
Not in Commercial Distribution

  • M2045180191 ()
  • M2045180190 ()
518-019

  • Pacing/defibrillation lead stylet
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