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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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A.M.I. HAL Knotpusher - EAMIAHK0070

Knot pusher for placing knots when ligating haemorrhoidal arteries. Part of the A.M.I. HAL / RAR System. The various Knotpushers are intended for ligature passing and know tying.
AMI Agency for Medical Innovations GmbH
AHK 007
In Commercial Distribution

  • EAMIAHK0070 ()
AHK 007

  • Suture knot pusher, reusable

A.M.I. HAL Handle - EAMIAHH0010

Handle for the HAL/RAR probes.
AMI Agency for Medical Innovations GmbH
AHH 001
In Commercial Distribution

  • EAMIAHH0010 ()
AHH 001

  • Noninvasive vascular ultrasound system

A.M.I. HAL-II Adaptor USA - EAMIAHA0030

No Description
AMI Agency for Medical Innovations GmbH
AHA 003
Not in Commercial Distribution

  • EAMIAHA0030 ()
AHA 003

  • Electrosurgical cable adaptor

A.M.I.-dock TissueBag DLU Large - EAMIA102120

Loading unit for retrieving specimen for A.M.I.-dock Applicator 10mm. The various types of retrieval bags belonging to the A.M.I. TissueBag System are intended for safe removal of specimen (appendix, gallbladder, ovaries, fibroid tumours and other tissues, and calculi) during laparoscopic surgery.
AMI Agency for Medical Innovations GmbH
A10 212
Not in Commercial Distribution

  • EAMIA102120 ()
  • EAMIA102121 ()

  • Length: 180 Millimeter
A10 212

  • Tissue extraction bag

A.M.I.-dock TissueBag DLU - EAMIA102110

Loading unit for retrieving specimen for A.M.I.-dock Applicator 10mm. The various types of retrieval bags belonging to the A.M.I. TissueBag System are intended for safe removal of specimen (appendix, gallbladder, ovaries, fibroid tumours and other tissues, and calculi) during laparoscopic surgery.
AMI Agency for Medical Innovations GmbH
A10 211
Not in Commercial Distribution

  • EAMIA102110 ()
  • EAMIA102111 ()

  • Length: 180 Millimeter
A10 211

  • Tissue extraction bag

A.M.I.-dock Bluntdissect DLU 10mm - EAMIA101310

Loading unit for blunt dissection for A.M.I.-dock Applicator 10mm. The Bluntdissect DLU`s are part of the A.M.I.-dock System which is a set of instruments intended for using during laparoscopic surgical procedures. The system consists of: - various A.M.I.-dock Applicators, delivered non sterile, - various A.M.I.-dock DLU’s (Disposable Loading Units), sterile packed, for different applications in the OR.
AMI Agency for Medical Innovations GmbH
A10 131
Not in Commercial Distribution

  • EAMIA101310 ()
  • EAMIA101311 ()

  • Length: 28 Millimeter
  • Outer Diameter: 8 Millimeter
A10 131

  • Dissection sponge

A.M.I.-dock Applicator Short 10mm - EAMIA101120

Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 10mm. The A.M.I.-dock Applicator serves as endoscopic multiple use carrier to operate the A.M.I.-dock Disposable Loading Units (DLU).
AMI Agency for Medical Innovations GmbH
A10 112
Not in Commercial Distribution

  • EAMIA101120 ()

  • Length: 392 Millimeter
  • Outer Diameter: 10 Millimeter
A10 112

  • Laparoscopic surgery handle

A.M.I.-dock Applicator Curved 5mm - EAMIA054930

Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 5mm. The A.M.I.-dock Applicator serves as endoscopic carrier for the A.M.I.-dock Disposable Loading Units (DLU).
AMI Agency for Medical Innovations GmbH
A05 493
Not in Commercial Distribution

  • EAMIA054930 ()

  • Length: 510 Millimeter
  • Outer Diameter: 5 Millimeter
A05 493

  • Laparoscopic surgery handle

A.M.I.-dock Applicator Short 5mm - EAMIA054920

Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 5mm. The A.M.I.-dock Applicator serves as endoscopic multiple use applicator for the A.M.I.-dock Disposable Loading Units (DLU).
AMI Agency for Medical Innovations GmbH
A05 492
Not in Commercial Distribution

  • EAMIA054920 ()

  • Length: 392 Millimeter
  • Outer Diameter: 5 Millimeter
A05 492

  • Laparoscopic surgery handle

A.M.I.-dock Bluntdissect DLU 5mm - EAMIA052510

Loading unit for blunt dissection for A.M.I.-dock Applicator 5 mm. The Bluntdissect DLU`s are part of the A.M.I.-dock System which is a set of instruments intended for using during laparoscopic surgical procedures. The system consists of: - various A.M.I.-dock Applicators, delivered non sterile, - various A.M.I.-dock DLU’s (Disposable Loading Units), sterile packed, for different applications in the OR.
AMI Agency for Medical Innovations GmbH
A05 251
Not in Commercial Distribution

  • EAMIA052510 ()
  • EAMIA052511 ()

  • Length: 18 Millimeter
  • Outer Diameter: 4.5 Millimeter
A05 251

  • Dissection sponge

FirstBurst Urine Collection Device v2 - B714C060005850

For the collection of the first catch male urine specimen. For in vitro diagnostic use.
Diagnostics For The Real World Limited
2.0
In Commercial Distribution

  • B714C060005 ()
  • B714C060005850 ()
C06-0005-85

  • Non-evacuated urine specimen container IVD, no additive

FirstBurst Urine Collection Device - B714C060003200

For the collection of the first catch male urine specimen. For in vitro diagnostic use.
Diagnostics For The Real World Limited
1.0
In Commercial Distribution

  • B714C060003200 ()
  • B714C060003 ()
C06-0003-20

  • Non-evacuated urine specimen container IVD, no additive

A.M.I. HAL-II Electronic System - EAMIAHE2030

Electronic unit for identifying the localised haemorrhoidal arteries by means of acoustic signals. Part of the A.M.I. HAL/RAR System. The A.M.I. HAL-II Electronic System is a Doppler-based device. It is powered by a DC voltage source (rechargeable batteries or 12 V adapter). The A.M.I. HAL-II Electronic System generates electrical signals, calculates differences between the wavelength of outgoing and reflected electrical signals, and generates an acoustic Doppler signal. Together with auxiliary A.M.I. devices (A.M.I. HAL Handle, Probe and Sleeve) the A.M.I. HAL-II Electronic System serves for the detection of haemorrhoidal arteries and enables manual ligation of detected arteries, as well as mucopexy of prolapsing haemorrhoidal mucosa.
AMI Agency for Medical Innovations GmbH
AHE 203
Not in Commercial Distribution

  • EAMIAHE2030 ()

  • Weight: 3.2 Kilogram
  • Depth: 260 Millimeter
  • Height: 140 Millimeter
  • Width: 385 Millimeter
AHE 203

  • Noninvasive vascular ultrasound system

A.M.I. Flexible Wire Guide - EAMIGBC3630

Wire guide for cutting a migrated silicone gastric band
AMI Agency for Medical Innovations GmbH
GBC 363
Not in Commercial Distribution

  • EAMIGBC3630 ()

  • Length: 1000 Millimeter
  • Outer Diameter: 4.5 Millimeter
  • Lumen/Inner Diameter: 0.8 Millimeter
GBC 363

  • Open-surgery dissector

A.M.I. FasciaCutter Disposable Instrument - EAMIAFC1000

The A.M.I. FasciaCutter Disposable Instrument is a sterile, disposable scalpel that is used to for enlargement of trocar incisions. The instrument is used in conjunction with an A.M.I. TissueBag for retrieval of specimen bags. The A.M.I. Fascia Cutter Disposable Instrument allows for easy removal of specimens in order to avoid risk of damaging the specimen bag while enlarging the trocar incision.
AMI Agency for Medical Innovations GmbH
AFC 100
Not in Commercial Distribution

  • EAMIAFC1000 ()

  • Outer Diameter: 13 Millimeter
  • Length: 195 Millimeter
AFC 100

  • Scalpel, single-use

A.M.I.-dock Applicator Standard 10mm - EAMIA101110

Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 10mm. The A.M.I.-dock Applicator serves as endoscopic multiple use carrier to operate the A.M.I.-dock Disposable Loading Units (DLU).
AMI Agency for Medical Innovations GmbH
A10 111
Not in Commercial Distribution

  • EAMIA101110 ()

  • Length: 500 Millimeter
  • Outer Diameter: 10 Millimeter
A10 111

  • Laparoscopic surgery handle

A.M.I.-dock Applicator Standard 5mm - AMIA054910

Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 5mm. The A.M.I.-dock Applicator serves as endoscopic carrier for the A.M.I.-dock Disposable Loading Units (DLU).
AMI Agency for Medical Innovations GmbH
A05 491
Not in Commercial Distribution

  • AMIA054910 ()

  • Length: 510 Millimeter
  • Outer Diameter: 5 Millimeter
A05 491

  • Laparoscopic surgery handle

SnoreLogic - 15035883000917

No Description
PASSION FOR LIFE HEALTHCARE (UK) LIMITED
SMAN-USA-001-V1
In Commercial Distribution

  • 15035883000917 ()


  • Mandible-repositioning sleep-disordered breathing orthosis

Turtlebrace - 20628634832145

The brace is composed of a low-temperature thermoplastic fused between a layer of 3D stretchable knitted fabric and a layer of 3D stretchable knitted velcro receptive fabric. The brace can be molded directly to the patient to immobilize a wrist, with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace. Velcro closure separate. Size medium (02), or large (03), Pediatric (PED)
9321-8758 Québec Inc
Wrist Pediatric
In Commercial Distribution

  • 20628634832145 ()

  • PED M for Pediatric Medium
  • PED L for Pediatric Large
HBPP-02,HBPP-03

  • Custom-made upper-limb orthosis

Turtlebrace - 20628634832084

The brace is composed of a low-temperature thermoplastic fused between layers of 3D stretchable knitted fabric. The brace can be molded directly to the patient to immobilize a wrist, with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace with velcro closure. Size medium (02), or large (03), Pediatric (PED)
9321-8758 Québec Inc
Wrist Pediatric with velcro closure
In Commercial Distribution

  • 20628634832084 ()

  • PED M for Pediatric Medium
  • PED L for Pediatric Large
TBPPV-02,TBPPV-03

  • Custom-made upper-limb orthosis

Turtlebrace - 20628634832077

The brace is composed of a low-temperature thermoplastic fused between layers of 3D stretchable knitted fabric. The brace can be molded directly to the patient to immobilize a wrist with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace with zipper closure. Size medium (02), or large (03), Pediatric (PED)
9321-8758 Québec Inc
Wrist Pediatric with zipper closure
In Commercial Distribution

  • 20628634832077 ()

  • PED M for Pediatric Medium
  • PED L for Pediatric Large
TBPPZ-02,TBPPZ-03

  • Custom-made upper-limb orthosis

Turtlebrace - 20628634832046

The brace is composed of a low-temperature thermoplastic fused between layers of 3D stretchable knitted fabric. The brace can be molded directly to the patient to immobilize an ankle, with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching for toe walkers), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace. Size small (01), medium (02), or large (03), Pediatric (PED)
9321-8758 Québec Inc
Ankle Pediatric Reinforced
In Commercial Distribution

  • 20628634832046 ()

  • PED M for pediatric medium
  • PED L for pediatric large
TBCPR-02, TBCPR-03

  • Custom-made lower-limb orthosis

Kendall - 20192253016823

Kendall Radiolucent Foam Monitoring electrode Tear drop shape
Cardinal Health 200, LLC
22935
In Commercial Distribution

  • 50192253016824 ()
  • 20192253016823 ()
  • 10192253016826 ()
22935

  • Electrocardiographic electrode, single-use

Kendall - 20192253016656

Kendall 450 series Monitoring Foam electrode Rectangular shape
Cardinal Health 200, LLC
22450
In Commercial Distribution

  • 50192253016657 ()
  • 20192253016656 ()
  • 10192253016659 ()
22450

  • Electrocardiographic electrode, single-use

BOSS Instruments - 00888515326088

Cast Cutter Blade - Super Coat Slotted/Semicircular Shape
BOSS INSTRUMENTS, LTD., INC.
79-4025SC
In Commercial Distribution

  • 00888515326088 ()
79-4025SC

  • Cast cutter blade

Kendall - 20192253017448

SF3040Adult Monitoring, Radiolucent Foam electrode Tear drop shape
Cardinal Health 200, LLC
31452389
In Commercial Distribution

  • 30192253017445 ()
  • 20192253017448 ()
  • 10192253016734 ()
  • 50192253017449 ()
31452389

  • Electrocardiographic electrode, single-use

Kendall - 20192253017240

Kendall 200 series Foam Monitoring electrode Teardrop shape
Cardinal Health 200, LLC
31078135
In Commercial Distribution

  • 50192253017241 ()
  • 20192253017240 ()
  • 10192253017243 ()
31078135

  • Electrocardiographic electrode, single-use

Kendall - 20192253016984

Kendall H92SG ,Foam monitoring electrode - Oval shape 57x34mm
Cardinal Health 200, LLC
31.1925.21
In Commercial Distribution

  • 30192253016981 ()
  • 20192253016984 ()
  • 10192253016987 ()
31.1925.21

  • Electrocardiographic electrode, single-use

Indigo System - 00815948022928

CAT12 115 New HTORQ shape Plus Lightning, CE
PENUMBRA, INC.
LITNG12HTORQ115
In Commercial Distribution

  • 00815948022928 ()


  • Thrombectomy suction catheter
  • Suction/irrigation tubing, single-use

Indigo System - 00815948022904

CAT12 100 New HTORQ shape Plus Lightning, CE
PENUMBRA, INC.
LITNG12HTORQ100
In Commercial Distribution

  • 00815948022904 ()


  • Thrombectomy suction catheter
  • Suction/irrigation tubing, single-use

Indigo System - 00815948022935

CAT12 115 New XTORQ shape Plus Lightning, CE
PENUMBRA, INC.
LITNG12XTORQ115
In Commercial Distribution

  • 00815948022935 ()


  • Thrombectomy suction catheter
  • Suction/irrigation tubing, single-use

Indigo System - 00815948022911

CAT12 100 New XTORQ shape Plus Lightning, CE
PENUMBRA, INC.
LITNG12XTORQ100
In Commercial Distribution

  • 00815948022911 ()


  • Thrombectomy suction catheter
  • Suction/irrigation tubing, single-use

RETRACTOR - 00888118060716

AIACH, S SHAPE, 8 X 14 MM BLADE
KLS-Martin L.P.
37-701-02-07
In Commercial Distribution

  • 00888118060716 ()

  • 14 CM


  • Soft-tissue surgical hook, reusable

RETRACTOR - 00888118060709

AIACH, S SHAPE, 8 X 11 MM BLADE
KLS-Martin L.P.
37-701-01-07
In Commercial Distribution

  • 00888118060709 ()

  • 10.5 CM


  • Soft-tissue surgical hook, reusable

GOUGE - 00888118059765

SEPTUM, KILLIAN CLAUS, V SHAPE, 5 MM TIP
KLS-Martin L.P.
37-605-16-07
In Commercial Distribution

  • 00888118059765 ()

  • 16 CM


  • Surgical gouge

STRIPPER - 00888118070876

MANDIBULAR, PERIOSTEAL, OBWEGESER, J SHAPE, 9 MM TIP
KLS-Martin L.P.
48-152-09-07
In Commercial Distribution

  • 00888118070876 ()

  • 20.5 CM


  • Bone file/rasp, manual, reusable

STRIPPER - 00888118070869

MANDIBULAR, PERIOSTEAL, OBWEGESER, J SHAPE, 7 MM TIP
KLS-Martin L.P.
48-152-07-07
In Commercial Distribution

  • 00888118070869 ()

  • 20.5 CM


  • Bone file/rasp, manual, reusable

STRIPPER - 00888118070852

MANDIBULAR, PERIOSTEAL, OBWEGESER, J SHAPE, 5 MM TIP
KLS-Martin L.P.
48-152-05-07
In Commercial Distribution

  • 00888118070852 ()

  • 20.5 CM


  • Bone file/rasp, manual, reusable

RONGEUR - 00888118030245

MICRO, BONE, KLS MARTIN, S SHAPE, 30* UP
KLS-Martin L.P.
23-780-04-07
In Commercial Distribution

  • 00888118030245 ()

  • 15 CM


  • Orthopaedic joint/limb rongeur

Surgical Direct - B382SD036090

5mm Flexible Laparoscopic Retractor, Round Shape, Formable Retractor
Surgical Direct, Inc.
SD03609
In Commercial Distribution

  • B382SD036090 ()

  • Outer Diameter: 5 Millimeter
SD03609

  • Endoscope sheath, reusable
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