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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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Antrum punch with collector - 04250381813898

18 cm, 2 mm, incl. stylet
Spiggle & Theis Medizintechnik GmbH
30-450-20
In Commercial Distribution

  • 04250381813898 ()
30-450-20

  • Bone-coring punch, reusable

Simplex HV with Gentamicin - 04260056885761

Simplex® HV with Gentamicin is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. Simplex® HV with Gentamicinn cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. Simplex® HV with Gentamicin does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
OSARTIS GmbH
6195-1-001
In Commercial Distribution

  • 24260056885765 ()
  • 14260056885768 ()
  • 04260056885761 ()

  • Total Volume: 20 Milliliter
  • Weight: 40.8 Gram
6195-1-010

  • Orthopaedic cement, antimicrobial

AuDX Device with touchscreen - 04260223143281

AuDX branded Sentiero
PATH medical GmbH
100098-AU
In Commercial Distribution

  • 04260223143281 ()


  • Evoked-potential audiometer

coflex-F Handle with ratchet - 04260148897689

No Description
Paradigm Spine GmbH
RAT20500
In Commercial Distribution

  • 04260148897689 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

HPS K-wire with cap - 04260148896613

No Description
Paradigm Spine GmbH
HAT50005
In Commercial Distribution

  • 04260148896613 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

DSS, K-wire with cap - 04260148893322

No Description
Paradigm Spine GmbH
DAT50005
In Commercial Distribution

  • 04260148893322 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Laser-suction tube with interruptor - 04250676742636

angled, distal opening on top 2.5 mm, 25 cm
Spiggle & Theis Medizintechnik GmbH
50-347-25-L
In Commercial Distribution

  • 04250676742636 ()
50-347-25-L

  • Surgical irrigation/aspiration cannula, non-illuminating, reusable

Retinoscopy rack with slider - 04049584007056

Retinoscopy rack with slider
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
48110
In Commercial Distribution

  • 04049584007056 ()


  • Trial lens frame

Leica TP1020 with Chloroform - 04049188087706

The instrument has been designed so that it is safe to use by the operator as well as for processing speci-mens—provided that it is operated according to these Instructions for Use. The Leica TP1020 is a modular automated tissue processor designed for the following laboratory applications: • Fixation • Dehydration • Paraffin infiltration of histological tissue specimens. The Leica TP1020 must be operated exclusively with the reagents listed in the IFU
Leica Biosystems Nussloch GmbH
000000014042242238
In Commercial Distribution

  • 04049188087706 ()

  • Device Size Text, specify:
14042242238

  • Tissue processor IVD, automated/semi-automated

Artificial Iris with Fiber - 04049154000012

The CustomFlex Artificial Iris is a prosthetic iris (the colored part of the eye around the pupil) made of thin, foldable medical-grade silicone. This device is custom-made and can be sized and colored for each individual patient. This with Fiber model has a polyester meshwork layer embedded in it to provide adequate tear strength to withstand suturing. The CustomFlex Artificial Iris can be used to treat congenital (genetic disorder in which the iris is completely or partially absent) and traumatic aniridia.It can also be used to treat iris defects due to other reasons or conditions, such as albinism, or surgical removal due to melanoma.
HumanOptics AG
95001
In Commercial Distribution

  • 04049154000012 ()

  • Outer Diameter: 12.8 Millimeter
00095001

  • Implantable iris prosthesis

INFINITY M500 WITH POWER - 04049098054447

No Description
DRAEGER MEDICAL SYSTEMS, INC.
MS20407
In Commercial Distribution

  • 04049098054447 ()


  • General-purpose multi-parameter bedside monitor

IDS WITH INTERGRATED MIB - 04049098053457

No Description
DRAEGER MEDICAL SYSTEMS, INC.
7489375
In Commercial Distribution

  • 04049098053457 ()


  • Patient monitoring system module, interfacing

ErgoGrip handle with HF-connector, - 04048223025055

ErgoGrip handle with HF-connector, switchable stepless lock, rotating. Rotation blocked when closed.
Pajunk GmbH Medizintechnologie
1292-30-10
Not in Commercial Distribution

  • 04048223025055 ()
1292-30-10

  • Surgical instrument handle, non-torque-limiting

drill with depth marking - 04048844519506

No Description
implantcast GmbH
02320115
In Commercial Distribution

  • 04048844519506 ()

  • Ø 3,2/115mm


  • Fluted surgical drill bit, reusable

drill with depth marking - 04048844519483

No Description
implantcast GmbH
02320040
In Commercial Distribution

  • 04048844519483 ()

  • Ø 3,2/40mm


  • Fluted surgical drill bit, reusable

Bonded C.L.R. With Tray - D82853001220

No Description
FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
5300122
In Commercial Distribution

  • D82853001220 ()


  • Orthodontic retainer

drill with depth marking - 04048844519490

No Description
implantcast GmbH
02320060
In Commercial Distribution

  • 04048844519490 ()

  • Ø 3,2/60mm


  • Fluted surgical drill bit, reusable

HME-Booster T-Piece with WFL - 05055788792314

No Description
FLEXICARE MEDICAL LIMITED
362-000-000U
In Commercial Distribution

  • 05055788792314 ()


  • Straight/elbow breathing circuit connector, single-use

ELEVATOR #46R WITH SERRATIONS - D928104046RSER0

No Description
W.H. Holden, Inc.
10-4046R-SER
In Commercial Distribution

  • D928104046RSER0 ()


  • Dental elevator, tooth/root

RETRACTOR NEIMARK-SIDAL (WITH CURVE) - D9281055771S0

No Description
W.H. Holden, Inc.
10-5577-1S
In Commercial Distribution

  • D9281055771S0 ()


  • Dental cheek retractor, professional, reusable

Biteblock with elastic necktape - 04250105605525

#6 ; suitable for Laryngeal Tubes: LTS-D #3, #4, #5 / Laryngeal Masks: #3, #4, #5
VBM Medizintechnik GmbH
40-66-060-1
In Commercial Distribution

  • 14250105605522 ()
  • 04250105605525 ()


  • Oropharyngeal airway, single-use

Biteblock with elastic necktape - 04250105604955

#5 ; suitable for Tracheal Tubes: 8.5 - 11.0 mm I.D. / Laryngeal Tubes: LTS-D #2, #2.5
VBM Medizintechnik GmbH
40-66-050-1
In Commercial Distribution

  • 14250105604952 ()
  • 04250105604955 ()


  • Oropharyngeal airway, single-use

Biteblock with elastic necktape - 04250105604948

#4 ; suitable for Tracheal Tubes: 6.5 - 8.0 mm I.D. / Laryngeal Masks: #2, #2.5
VBM Medizintechnik GmbH
40-66-040-1
In Commercial Distribution

  • 14250105604945 ()
  • 04250105604948 ()


  • Oropharyngeal airway, single-use

Restylane Lyft with Lidocaine - 00302995963262

No Description
Q-Med AB
Gel 1.0 ml syringe - demo
In Commercial Distribution

  • 00302995963262 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

Restylane Lyft with Lidocaine - 00302995963255

No Description
Q-Med AB
Gel 1 mL Syringe
In Commercial Distribution

  • 00302995963255 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

Restylane Lyft with Lidocaine - 00302995963248

No Description
Q-Med AB
Gel 1.0 ml syringe - demo
In Commercial Distribution

  • 00302995963248 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

SUTURE RING WITH TABS - 00841668111727

No Description
KATENA PRODUCTS, INC.
K30-1535
In Commercial Distribution

  • 10841668111724 ()
  • 00841668111727 ()
  • 20841668111721 ()
K30-1535

  • Vitrectomy sutureless lens holding ring, single-use

AFIAS iFOB with AFIAS-50 - 08806133005255

No Description
Boditech Med Inc.
CFPO-15-1
In Commercial Distribution

  • 08806133005255 ()
  • 18806133005252 ()
CFPO-15-1

  • Faecal occult blood IVD, reagent

Reinfusion bag with Y-adapter - 04052682000584

Reinfusion bag with Y-adapter contains a reinfusion bag and a Y-adapter to connect 2 reinfusion bags to the Packed Red Cells line.
Fresenius Kabi AG
9005164
In Commercial Distribution

  • 04052682000591 ()
  • 04052682000584 ()
9005164

  • Autotransfusion system blood component processing set

T-Handle with Torque Limiter - 04057217005850

No Description
Z-Medical GmbH + Co. KG
A16 007
In Commercial Distribution

  • 04057217005850 ()


  • Surgical instrument handle, torque-limiting

Slush Drape with Disk - 00848340008597

Disposable Equipment Cover
ADVANCE MEDICAL DESIGNS, INC.
40-SD320
In Commercial Distribution

  • 10848340008594 ()
  • 00848340008597 ()


  • Medical equipment handle cover, single-use

Slush Drape with Disk - 00848340008580

Disposable Equipment Cover
ADVANCE MEDICAL DESIGNS, INC.
40-SD220
In Commercial Distribution

  • 10848340008587 ()
  • 00848340008580 ()


  • Medical equipment handle cover, single-use

Slush Drape with Disk - 00848340008269

Disposable Equipment Cover
ADVANCE MEDICAL DESIGNS, INC.
40-SD120
In Commercial Distribution

  • 10848340008266 ()
  • 00848340008269 ()


  • Medical equipment handle cover, single-use

MAGNET HANDPIECE WITH CABLE - 04719873121205

No Description
BONART CO., LTD.
MS0002-412RH
In Commercial Distribution

  • 04719873121205 ()


  • Ultrasonic dental scaling/debridement system

Miracle Suctions with Mirror - 08806383524483

Multifunctional Mirror with Suction
DiaDent Group International
Plastic adapter 16mm
In Commercial Distribution

  • 08806383524483 ()
901-403

  • Dental mirror, reusable

Miracle Suctions with Mirror - 08806383524476

Multifunctional Mirror with Suction
DiaDent Group International
Plastic adapter 18mm
In Commercial Distribution

  • 08806383524476 ()
901-404

  • Dental mirror, reusable

Miracle Suctions with Mirror - 08806383524469

Multifunctional Mirror with Suction
DiaDent Group International
Plastic adapter
In Commercial Distribution

  • 08806383524469 ()
901-401

  • Dental mirror, reusable

Miracle Suctions with Mirror - 08806383524377

Multifunctional Mirror with Suction
DiaDent Group International
YELLOW
In Commercial Distribution

  • 08806383524377 ()
901-101

  • Dental mirror, reusable

Trinity with no TPS - 05055343880968

Trinity Non-occluded Titanium Plasma Spray Acetabular Shell Ø48mm Taper Size 2
CORIN LTD
320.02.348
In Commercial Distribution

  • 05055343880968 ()
320.02.348

  • Acetabular shell

Trinity with no TPS - 05055343880951

Trinity Non-occluded Titanium Plasma Spray Acetabular Shell Ø46mm Taper Size 1
CORIN LTD
320.01.346
In Commercial Distribution

  • 05055343880951 ()
320.01.346

  • Acetabular shell
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