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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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CASE MEDICAL - 00653159010316

MED42 Spare Parts Kit
Case Medical Inc.
MED42KIT
In Commercial Distribution

  • 00653159010316 ()
MED42KIT

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159010309

MED41 Spare Parts Kit
Case Medical Inc.
MED41KIT
In Commercial Distribution

  • 00653159010309 ()
MED41KIT

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159010293

MED40 Spare Parts Kit
Case Medical Inc.
MED40KIT
In Commercial Distribution

  • 00653159010293 ()
MED40KIT

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159010231

MED38 Spare Parts Kit
Case Medical Inc.
MED38KIT
In Commercial Distribution

  • 00653159010231 ()
MED38KIT

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159010224

MED39 Spare Parts Kit
Case Medical Inc.
MED39KIT
In Commercial Distribution

  • 00653159010224 ()
MED39KIT

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159010217

Starter Kit Low Temperature
Case Medical Inc.
SCKIT8
In Commercial Distribution

  • 00653159010217 ()
SCKIT8

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159010200

ENT ENDOSCOPE TRAY
Case Medical Inc.
ELEVETRAY
In Commercial Distribution

  • 00653159010200 ()
ELEVETRAY

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159010194

BARIATRIC LAPAROSCOPE TRAY
Case Medical Inc.
ELEVBTRAY
In Commercial Distribution

  • 00653159010194 ()
ELEVBTRAY

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159010187

LAPAROSCOPE TRAY
Case Medical Inc.
ELEVLTRAY
In Commercial Distribution

  • 00653159010187 ()
ELEVLTRAY

  • Device sterilization/disinfection container, reusable

Case Medical, Inc - 00653159010156

MULTI-ENZYMATIC SURFACE CLEANER WIPES
Case Medical Inc.
CSWE002
In Commercial Distribution

  • 00653159010156 ()
CSWE002

  • Medical device cleaning/disinfection wipe

CASE MEDICAL - 00653159010132

IR SCOPE TRAY
Case Medical Inc.
115-0020
In Commercial Distribution

  • 00653159010132 ()
115-0020

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159010125

IR CAMERA TRAY
Case Medical Inc.
115-0010
In Commercial Distribution

  • 00653159010125 ()
115-0010

  • Device sterilization/disinfection container, reusable

Case Medical - 00653159010071

Medtronic Stealth Technology Navigation Tray
Case Medical Inc.
9736064
In Commercial Distribution

  • 00653159010071 ()
9736064

  • Instrument tray, reusable
  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159009877

TRAY CRANIAL VERTEK™ BIOPSY
Case Medical Inc.
9733770
In Commercial Distribution

  • 00653159009877 ()
9733770

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159009860

TRAY CRANIAL NAVIGATION
Case Medical Inc.
9733771
In Commercial Distribution

  • 00653159009860 ()
9733771

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159009853

Tray Cranial Registration
Case Medical Inc.
9733769
In Commercial Distribution

  • 00653159009853 ()
9733769

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159009600

SURETRAK 2 CONTAINER AND TRAY SET
Case Medical Inc.
9733770
In Commercial Distribution

  • 00653159009600 ()
9733770

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159009402

CASE MAZ600S MR MAZOR STERILIZATN 3/4DIN
Case Medical Inc.
MAZ600S
In Commercial Distribution

  • 00653159009402 ()


  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159009396

CONTAINER ENT MR8 1847CNTR STERIL 1/2 DIN
Case Medical Inc.
1847CNTR
In Commercial Distribution

  • 00653159009396 ()


  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159009327

SC06FG CLEAR LINE STANDARD CASE
Case Medical Inc.
NS01CASE
In Commercial Distribution

  • 00653159009327 ()
NS01CASE

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159009051

DISPOSABLE NON-WOVEN FILTERS 10"x4" (1000 PK) DEPUY
Case Medical Inc.
DPY-SCFM02
In Commercial Distribution

  • 00653159009051 ()
DPY-SCFM02

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159009037

DISPOSABLE CELLULOSIC FILTERS 7.5" DIA. (1000PK) DEPUY
Case Medical Inc.
DPY-SCF01
In Commercial Distribution

  • 00653159009037 ()
DPY-SCF01

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159008993

CONTAINER SYSTEM, SEMI-RIGID
Case Medical Inc.
KSZ-39301SR
In Commercial Distribution

  • 00653159008993 ()
KSZ-39301SR

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159008931

CONTAINER SYSTEM, SEMI-RIGID, SHORT
Case Medical Inc.
KSZ-39301SP
In Commercial Distribution

  • 00653159008931 ()
KSZ-39301SP

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159008924

CONTAINER SYSTEM, VIDEO MEDIASTINOSCOPE SET
Case Medical Inc.
KSZ-39312VMS
In Commercial Distribution

  • 00653159008924 ()
KSZ-39312VMS

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159008917

CONTAINER SYSTEM, RESECTION
Case Medical Inc.
KSZ-39312D
In Commercial Distribution

  • 00653159008917 ()
KSZ-39312D

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159008894

CONTAINER, PNCL SET
Case Medical Inc.
KSZ-39312J
In Commercial Distribution

  • 00653159008894 ()
KSZ-39312J

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159008887

CONTAINER, MIP SET
Case Medical Inc.
KSZ-39312M
In Commercial Distribution

  • 00653159008887 ()
KSZ-39312M

  • Device sterilization/disinfection container, reusable

UTF Hip Stem - 04719872177807

UTF Stem, reduced case #2
UNITED ORTHOPEDIC CORP.
9106-8320-RT
In Commercial Distribution

  • 04719872177807 ()

  • reduced case #2
9106-8320-RT

  • Instrument tray, reusable

UTF Hip Stem - 04719872177791

UTF Stem, reduced case #1
UNITED ORTHOPEDIC CORP.
9106-8310-RT
In Commercial Distribution

  • 04719872177791 ()

  • reduced case #1
9106-8310-RT

  • Instrument tray, reusable

UTF Hip Stem - 04719872177784

UTF Stem, reduced, case #1
UNITED ORTHOPEDIC CORP.
9106-8310-RC
In Commercial Distribution

  • 04719872177784 ()

  • reduced, case #1
9106-8310-RC

  • Instrument tray, reusable

UTF Hip Stem - 04719872172758

UTF Stem, reduced, case #2
UNITED ORTHOPEDIC CORP.
9106-8320
In Commercial Distribution

  • 04719872172758 ()

  • reduced, case #2
9106-8320

  • Instrument tray, reusable

UTF Hip Stem - 04719872172741

UTF Stem, reduced, case #1
UNITED ORTHOPEDIC CORP.
9106-8310-RA
In Commercial Distribution

  • 04719872172741 ()

  • reduced, case #1
9106-8310-RA

  • Instrument tray, reusable

UTF Hip Stem - 04719872172734

UTF Stem, reduced case #1
UNITED ORTHOPEDIC CORP.
9106-8310
In Commercial Distribution

  • 04719872172734 ()

  • reduced case #1
9106-8310

  • Instrument tray, reusable

GSO PCT Spinal System - M9935071800

Implant Instrument Case
UNIFIED SPINE, LLC
507180
In Commercial Distribution

  • M9935071800 ()

  • Implant Instrument Case


  • Surgical instrument/implant rack

GSO GS1 Spinal System - M9935042030

Instrument Case
UNIFIED SPINE, LLC
504203
In Commercial Distribution

  • M9935042030 ()

  • General Instrument Case


  • Surgical instrument/implant rack

Vital™ MIS Spinal Fixation System - 00887868310645

No Description
BIOMET SPINE LLC
800M1400
In Commercial Distribution

  • 00887868310645 ()

  • PASIT Stylus Case
800M1400

  • Instrument tray, reusable

CS2 Acetabular System - 00840286855204

CS2 Acetabular Trials Case 2
Shalby Advanced Technologies, Inc.
55048-00
In Commercial Distribution

  • 00840286855204 ()

  • Trials Case 2
55048-00

  • Instrument tray, reusable

CS2 Acetabular System - 00840286855198

CS2 Acetabular Reamer Case 1
Shalby Advanced Technologies, Inc.
55047-00
In Commercial Distribution

  • 00840286855198 ()

  • Reamer Case 1
55047-00

  • Instrument tray, reusable

TaperSet Hip System - 00840286840453

TaperSet, Instrument Case
Shalby Advanced Technologies, Inc.
55020-00
In Commercial Distribution

  • 00840286840453 ()

  • TaperSet, Instrument Case
55020-00

  • Instrument tray, reusable

Consensus Hip System - 00840286841733

CHS, Assy, Broach Case
Shalby Advanced Technologies, Inc.
55039-00
In Commercial Distribution

  • 00840286841733 ()

  • Assy, Broach Case
55039-00

  • Instrument tray, reusable

Consensus Hip System - 00840286841573

CHS, Assy, Reamer Case
Shalby Advanced Technologies, Inc.
55038-00
In Commercial Distribution

  • 00840286841573 ()

  • Assy, Reamer Case
55038-00

  • Instrument tray, reusable

Universal Lateral Positioner® - 00696588001036

Universal Lateral Positioner® Storage Case
Innovative Medical Products, Inc
1092- CASE
In Commercial Distribution

  • 00696588001036 ()
1092- CASE

  • Medical capital equipment storage bag/case

N/A - 00613994556233

CASE 9233100 CASE
MEDTRONIC SOFAMOR DANEK, INC.
9233100
In Commercial Distribution

  • 00613994556233 ()


  • Instrument tray, reusable

Jacoti Listen App - 05407004250014

Jacoti Listen App 2.X
Jacoti
Jacoti Listen App 2.X
In Commercial Distribution

  • 05407004250014 ()


  • Air-conduction hearing aid, wearable case

iHear EON - 00850965008456

A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum through an ear tip that fits inside the the ear canal. The device is used for mild to severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors
IHEAR MEDICAL, INC.
EON-KIT-STD
In Commercial Distribution

  • 00850965008470 ()
  • 00850965008456 ()


  • Air-conduction hearing aid, wearable case

GN Otometrics A/S - 05713315004155

No Description
Natus Medical Denmark ApS
NOAHLINK
In Commercial Distribution

  • 05713315004155 ()


  • Air-conduction hearing aid, wearable case

GN Otometrics A/S - 05713315001093

1081, LOUDSPEAKER
Natus Medical Denmark ApS
1081, LOUDSPEAKER
In Commercial Distribution

  • 05713315001093 ()
8-62-45200

  • Air-conduction hearing aid, wearable case

TIANLE - 06937572804535

Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-9858M
In Commercial Distribution

  • 06937572804535 ()


  • Air-conduction hearing aid, wearable case

TIANLE - 06937572804528

Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-93CM
In Commercial Distribution

  • 06937572804528 ()


  • Air-conduction hearing aid, wearable case
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