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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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Medline ReNewal - 10888277393820

MDS620SQ GARMENT, MEDLINE, DVT, SEQUENT
MEDLINE INDUSTRIES, INC.
TMREP114050
In Commercial Distribution

  • 10888277393820 ()

  • circumference up to 13 inches
TMREP114050

  • Intermittent venous compression system

Medline ReNewal - 10884389198476

MDS601PD VASO-FORCE INTERMITTENT SLEEVE
MEDLINE INDUSTRIES, INC.
REP115685
In Commercial Distribution

  • 10884389198476 ()

  • circumference up to 12 inches
REP115685

  • Single-chamber venous compression system garment, reprocessed

TRACOE® modular - 04035324012923

TRACOE phon assist I with Oxygen Supply Port
Tracoe medical GmbH
REF 650-SO
Not in Commercial Distribution

  • 04035324012923 ()

  • Fits to 22 mm adapter


  • Tracheostomy tube speech valve

Swish™ Countersink Drill - 10841307117360

No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
SPCD5-6
In Commercial Distribution

  • 10841307117360 ()

  • Diameter: 5.7 flares to 6.5
SPCD5-6

  • Fluted surgical drill bit, reusable

Swish™ Countersink Drill - 10841307117353

No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
SPCD4.8
In Commercial Distribution

  • 10841307117353 ()

  • Diameter: 4.8 flares to 4.8
SPCD4.8

  • Fluted surgical drill bit, reusable

Swish™ Countersink Drill - 10841307117346

No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
SPCD4.1
In Commercial Distribution

  • 10841307117346 ()

  • Diameter: 4.1 flares to 4.8
SPCD4.1

  • Fluted surgical drill bit, reusable

Swish™ Countersink Drill - 10841307117339

No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
SPCD4-6
In Commercial Distribution

  • 10841307117339 ()

  • Diameter: 4.8 flares to 6.5
SPCD4-6

  • Fluted surgical drill bit, reusable

Swish™ Countersink Drill - 10841307117322

No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
SPCD3.3
In Commercial Distribution

  • 10841307117322 ()

  • Diameter: 3.3 flares to 3.7
SPCD3.3

  • Fluted surgical drill bit, reusable

Instinct™ Java® System - 00889024341616

No Description
ZIMMER SPINE
046W0AN61354
In Commercial Distribution

  • 00889024341616 ()

  • 5.5/6.0 to 4.0mm Diameter


  • Bone-screw internal spinal fixation system, non-sterile

Instinct™ Java® System - 00889024341586

No Description
ZIMMER SPINE
046W0AN60355
In Commercial Distribution

  • 00889024341586 ()

  • 5.5/6.0 to 4.0mm Diameter


  • Bone-screw internal spinal fixation system, non-sterile

Instinct™ Java® System - 00889024341579

No Description
ZIMMER SPINE
046W0AN60354
In Commercial Distribution

  • 00889024341579 ()

  • 5.5/6.0 to 4.0mm Diameter


  • Bone-screw internal spinal fixation system, non-sterile

PRO OSTEON 200R - 00888480584360

Resorbable Bone Graft Substitute - Granules
Biomet Orthopedics, LLC
2RG15
In Commercial Distribution

  • 00888480584360 ()

  • 15cc (0.5mm to 1mm ø)
2RG15

  • Bone matrix implant, synthetic, non-antimicrobial

PRO OSTEON 200R - 00888480584353

Resorbable Bone Graft Substitute - Granules
Biomet Orthopedics, LLC
2RG05
In Commercial Distribution

  • 00888480584353 ()

  • 5cc (0.5mm to 1mm ø)
2RG05

  • Bone matrix implant, synthetic, non-antimicrobial

PRO OSTEON 200R - 00888480584346

Resorbable Bone Graft Substitute - Granules
Biomet Orthopedics, LLC
2RG02
In Commercial Distribution

  • 00888480584346 ()

  • 2cc (0.5mm to 1mm ø)
2RG02

  • Bone matrix implant, synthetic, non-antimicrobial

PRO OSTEON 200R - 00888480584339

Resorbable Bone Graft Substitute - Granules
Biomet Orthopedics, LLC
2RG005
In Commercial Distribution

  • 00888480584339 ()

  • 0.5cc (0.5mm to 1mm ø)
2RG005

  • Bone matrix implant, synthetic, non-antimicrobial

Assure - D798APP0

Assure paste is intended for use as light cure, hydrophilic bracket adhesive, therefore it can be applied to a dry or slightly contaminated surface. The smooth cohesive paste viscosity allows for easy application to any style bracket base insuring maximum mechanical retention.
RELIANCE ORTHODONTIC PRODUCTS INC
APP
In Commercial Distribution

  • D798APP0 ()
APP

  • Orthodontic bracket adhesive

JB CERVELLO 32 - 00850154007048

JackBox with 32 Common Reference Inputs, 21 arranged as Head Shape, 8 to be switched to Bipolar, to be used with CERVELLO 32 Series Headboxes
BLACKROCK NEUROMED, LLC
7512
In Commercial Distribution

  • 00850154007048 ()
7512

  • Electroencephalography telemetric monitoring system

Power Dental USA - D94320060

KRAMER NEVINES TG
Power Dental U.S.A. Inc.
2006
In Commercial Distribution

  • D94320060 ()
2006

  • Dressing/utility forceps, scissors-like, reusable
  • Periodontal hoe

HU-FRIEDY - 10889950007393

TG Chisel, Modified
HU-FRIEDY MFG. CO., LLC
CTG-O6
In Commercial Distribution

  • 10889950007393 ()
CTG-O6

  • Periodontal file/rasp, manual

HU-FRIEDY - 10889950007386

Modified TG Chisel
HU-FRIEDY MFG. CO., LLC
CTG-O
In Commercial Distribution

  • 10889950007386 ()
CTG-O

  • Periodontal file/rasp, manual

HU-FRIEDY - 10889950007379

TG DE Chisel
HU-FRIEDY MFG. CO., LLC
CTG6
In Commercial Distribution

  • 10889950007379 ()
CTG6

  • Periodontal file/rasp, manual

HU-FRIEDY - 10889950007362

TG DE Chisel
HU-FRIEDY MFG. CO., LLC
CTG
In Commercial Distribution

  • 10889950007362 ()
CTG

  • Periodontal file/rasp, manual

KOHDENT - 04251436926839

PA-Chisel - TRINOVO - TG
Kohler Medizintechnik GmbH
7645
In Commercial Distribution

  • 04251436926839 ()
7645

  • Orthopaedic chisel

ZOLL-DENTAL - 00840105209744

Kirkland #13K/TG
Zoll-Dental
PC-Kirk13K/TG
In Commercial Distribution

  • 00840105209744 ()


  • Periodontal hoe

iProvèn - 08719481720193

Ear thermometer with bluetooth which transmits data to app on mobile phone
Masena Invest B.V.
ET-624BT
In Commercial Distribution

  • 08719481720193 ()


  • Intermittent electronic patient thermometer

TM "Rehabilitimed" RP-6P XS Comfort - 04823097723517

The arm support scarf provides a medium degree of fixation of the elbow joint and shoulder girdle in graphite color. Equipped with a belt around the waist for more precise fixation and prevention of arm abduction. Made of durable material with a high cotton content and equipped with an adjustable strap for the neck and upper arm.
REABILITIMED TOV
RP-6P XS Comfort
In Commercial Distribution

  • 04823097723517 ()

  • Forearm length from elbow to middle of palm (inch): up to 10
RP-6P XS Comfort

  • Elbow orthosis

TM "Rehabilitimed" RP-6P XS Comfort - 04823097723494

The arm support scarf provides a medium degree of fixation of the elbow joint and shoulder girdle in turquoise blue. Equipped with a belt around the waist for more precise fixation and prevention of arm abduction. Made of durable material with a high cotton content and equipped with an adjustable strap for the neck and upper arm.
REABILITIMED TOV
RP-6P XS Comfort
In Commercial Distribution

  • 04823097723494 ()

  • Forearm length from elbow to middle of palm (inch): up to 10
RP-6P XS Comfort

  • Elbow orthosis

TM "Rehabilitimed" RP-6 XS Comfort - 04823097723418

The arm support bandana provides a medium degree of fixation of the elbow joint and shoulder girdle in graphite color. Made of durable material with a high cotton content and equipped with an adjustable neck and shoulder strap.
REABILITIMED TOV
RP-6 XS Comfort
In Commercial Distribution

  • 04823097723418 ()

  • Forearm length from elbow to middle of palm (inch): up to 10
RP-6 XS Comfort

  • Elbow orthosis

TM "Rehabilitimed" RP-6 XS Comfort - 04823097723395

The arm support bandana provides a medium degree of fixation of the elbow joint and shoulder girdle in turquoise blue. Made of durable material with a high cotton content and equipped with an adjustable neck and shoulder strap.
REABILITIMED TOV
RP-6 XS Comfort
In Commercial Distribution

  • 04823097723395 ()

  • Forearm length from elbow to middle of palm (inch): up to 10
RP-6 XS Comfort

  • Elbow orthosis

Auto chart projector - 06971821404015

ACP-1500 Auto projector ACP-1500 Auto projector adopts new optical bench and helical focusing, more convenient to operate and image sharpness more clear and easier to adjust . Changed to electric control, chart switch speed is improved to 30% faster than ACP-1000, with locating faster, more precise and less dithering. Upgraded optical bench, solving the problem of fogging and dust gathering under long-hour working New design for ACP-1500, modern and fashinable.
Ningbo Ming Sing Optical R & D Co., Ltd.
ACP-1500
In Commercial Distribution

  • 06971821404015 ()


  • Visual acuity projector

Oticon - 05707131328540

REMOTELINK 1.2 ANDROID
Oticon A/S
176637
In Commercial Distribution

  • 05707131328540 ()


  • Hearing aid/implant system remote control

Lehiso - 05713708000146

REMOTELINK 1.10 ANDROID
Lehiso A/S
199526
Not in Commercial Distribution

  • 05713708000146 ()


  • Hearing aid/implant system remote control

Lehiso - 05713708000122

REMOTELINK 1.9 ANDROID
Lehiso A/S
189261
Not in Commercial Distribution

  • 05713708000122 ()


  • Hearing aid/implant system remote control

Lehiso - 05713708000078

REMOTELINK 1.8 ANDROID
Lehiso A/S
185789
Not in Commercial Distribution

  • 05713708000078 ()


  • Hearing aid/implant system remote control

Philips - 05714464000074

HEARLINK 1.0 ANDROID
Sbo Hearing A/S
199531
In Commercial Distribution

  • 05714464000074 ()


  • Hearing aid/implant system remote control

Lehiso - 05713708000221

REMOTELINK 2.1.0 ANDROID
Lehiso A/S
214714
Not in Commercial Distribution

  • 05713708000221 ()


  • Hearing aid/implant system remote control

Lehiso - 05713708000184

REMOTELINK 2.0 ANDROID
Lehiso A/S
204457
Not in Commercial Distribution

  • 05713708000184 ()


  • Hearing aid/implant system remote control

Bernafon - 05711583029917

EASYCONTROL-A 1.4 ANDROID
Bernafon AG
178501
In Commercial Distribution

  • 05711583029917 ()


  • Hearing aid/implant system remote control

Bernafon - 05711584115886

EASYCONTROL-A 2.1.0 ANDROID
Bernafon AG
214718
In Commercial Distribution

  • 05711584115886 ()


  • Hearing aid/implant system remote control

Bernafon - 05711584106587

EASYCONTROL-A 2.0 ANDROID
Bernafon AG
204544
In Commercial Distribution

  • 05711584106587 ()


  • Hearing aid/implant system remote control
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