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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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Integra® MOVEMENT® Great Toe System - 10381780116431

The Integra Movement Great Toe System phalangeal component is designed for resurfacing the base of the proximal phalanx. The component is an anatomically designed, monolithic device. The device is made from cobalt chromium alloy with a commerically pure titanium plasma spray. The phalangeal component is intended as hemi-arthroplasty at the surface and is press-fit.
Ascension Orthopedics, Inc.
MGT89020PPH
In Commercial Distribution

  • 10381780116431 ()
  • M268MGT89020PPH1 ()

  • .660 in L x .492 in W x .394 in H; Size 20
MGT89020PPH

  • Partial metatarsophalangeal joint prosthesis

Integra® MOVEMENT® Great Toe System - 10381780116417

The Integra Movement Great Toe System phalangeal component is designed for resurfacing the base of the proximal phalanx. The component is an anatomically designed, monolithic device. The device is made from cobalt chromium alloy with a commerically pure titanium plasma spray. The phalangeal component is intended as hemi-arthroplasty at the surface and is press-fit.
Ascension Orthopedics, Inc.
MGT89010PPH
In Commercial Distribution

  • 10381780116417 ()
  • M268MGT89010PPH1 ()

  • .606 in L x .463 in W x .354 in H; Size 10
MGT89010PPH

  • Partial metatarsophalangeal joint prosthesis

Mendit Retriever Set - 07290019174202

Retriever Cartridge is available in addition to the Applicator Cartridge and its use is optional. The Retriever Cartridge operated by the Handle (forming the “Retriever”) is used to retrieve the anchor-suture assembly after it has been placed on ligament. Retrieval of the Implant may be followed by the placement of a new anchor-suture assembly.
ESCALA MEDICAL LTD
Mendit Retriever Set - permanent suture (ePTFE USP 0)
In Commercial Distribution

  • 07290019174202 ()
ES0517

  • Soft-tissue/mesh anchor, bioabsorbable

Mendit Retriever Set - 07290019174196

Retriever Cartridge is available in addition to the Applicator Cartridge and its use is optional. The Retriever Cartridge operated by the Handle (forming the “Retriever”) is used to retrieve the anchor-suture assembly after it has been placed on ligament. Retrieval of the Implant may be followed by the placement of a new anchor-suture assembly.
ESCALA MEDICAL LTD
Mendit Retriever Set - permanent suture (ePTFE 2-0)
In Commercial Distribution

  • 07290019174196 ()
ES0512

  • Soft-tissue/mesh anchor, bioabsorbable

Mendit Retriever Set - 07290019174189

Retriever Cartridge is available in addition to the Applicator Cartridge and its use is optional. The Retriever Cartridge operated by the Handle (forming the “Retriever”) is used to retrieve the anchor-suture assembly after it has been placed on ligament. Retrieval of the Implant may be followed by the placement of a new anchor-suture assembly.
ESCALA MEDICAL LTD
Mendit Retriever Set - permanent suture (Prolene USP 0)
In Commercial Distribution

  • 07290019174189 ()
ES0525

  • Soft-tissue/mesh anchor, bioabsorbable

Mendit Retriever Set - 07290019174172

Retriever Cartridge is available in addition to the Applicator Cartridge and its use is optional. The Retriever Cartridge operated by the Handle (forming the “Retriever”) is used to retrieve the anchor-suture assembly after it has been placed on ligament. Retrieval of the Implant may be followed by the placement of a new anchor-suture assembly.
ESCALA MEDICAL LTD
Mendit Retriever Set - Resorbable suture (PDS USP 0)
In Commercial Distribution

  • 07290019174172 ()
ES0530

  • Soft-tissue/mesh anchor, bioabsorbable

Implantswiss - 07640168189655

Tissue level Wide Premill Abutment 16 x 1 mm Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure.
Novodent SA
S-TWPA16
In Commercial Distribution

  • 07640168189655 ()
S-TWPA16

  • Dental implant suprastructure, permanent, preformed

Implantswiss - 07640168189648

Tissue level Wide Premill Abutment 14 x 1 mm Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure.
Novodent SA
S-TWPA14
In Commercial Distribution

  • 07640168189648 ()
S-TWPA14

  • Dental implant suprastructure, permanent, preformed

Implantswiss - 07640168189631

Tissue level Wide Premill Abutment 10 x 1 mm Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure.
Novodent SA
S-TWPA10
In Commercial Distribution

  • 07640168189631 ()
S-TWPA10

  • Dental implant suprastructure, permanent, preformed

Implantswiss - 07640168189327

Bone level Couple Abutment 6.5 x 5.0 x H7 mm Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure.
Novodent SA
S-BCA65507
In Commercial Distribution

  • 07640168189327 ()
S-BCA65507

  • Dental implant suprastructure, permanent, preformed
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