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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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I-neb - 00383730001005

I-neb Insight Online Multi-Lang Assembly
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
Not in Commercial Distribution

  • 00383730001005 ()
1100081

  • Ultrasonic nebulizing system

MIS Precision Chevron Bunion System - 00860005968800

The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subsequent fixation of the osteotomy, with a minimally invasive surgical technique. The MIS Precision Chevron Bunion System™ consists of a single, sterile-packaged SKU that contains both implants and instruments needed for the procedure. The implants in the kit are cannulated headless compression screws, made from titanium (Ti-6AL-4V ELI). There are two implants in the kit, however only one is used in a surgical procedure. Two implants are provided to allow the physician to select the proper size for the patient at the time of surgery. The implants are 3.5 mm diameter, with lengths of 24 mm and 27 mm. There are also single-use instruments, made of injection molded polycarbonate, PEEK, and stainless steel included in the MIS Precision Chevron Bunion System™. Instruments include an osteotomy guide (one each for left and right feet), a targeting guide, a screw guide, screwdriver, drill bit, and several K-wires and a guidewire. Additional general surgical instrumentation is utilized, but not part of the RELJA system, such as sagittal saw, drivers, and scalpel.
Relja Innovations LLC
RI-2427-C
In Commercial Distribution

  • 00860005968800 ()


  • Orthopaedic bone screw, non-bioabsorbable, sterile

NA - 06009544015208

Instrument, 1.22mm Tapered Hex Driver, Wrench Insert, Long
SOUTHERN IMPLANTS (PTY) LTD
I-WIT-22L
In Commercial Distribution

  • 06009544015208 ()


  • Dental implant/prosthesis surgical procedure kit

NA - 06009544015222

Instrument, 1.22mm Tapered Hex Driver, Wrench Insert, Short
SOUTHERN IMPLANTS (PTY) LTD
I-WIT-22S
In Commercial Distribution

  • 06009544015222 ()


  • Dental implant/prosthesis surgical procedure kit

NA - 06009544015215

Instrument, 1.22mm Tapered Hex Driver, Wrench Insert, Medium
SOUTHERN IMPLANTS (PTY) LTD
I-WIT-22M
In Commercial Distribution

  • 06009544015215 ()


  • Dental implant/prosthesis surgical procedure kit

BIO-MODULAR - 00880304365186

No Description
Biomet Orthopedics, LLC
406514
In Commercial Distribution

  • 00880304365186 ()
406514

  • Orthopaedic implant aiming/guiding block, reusable

Burr Hole Cover - 00855547005205

The Burr Hole Cover package contains 1 Burr Hole Cover.
Neuropace, Inc.
8110
In Commercial Distribution

  • 00855547005205 ()

  • Compatible with a 1.3 mm lead. Requires three 1.5 to 1.8 mm bone screws.
  • Outer Diameter: 14 Millimeter


  • Cranial bur hole cover
  • Craniofacial fixation plate, non-bioabsorbable, non-customized

HammerTech - 00852164007650

HT Ti Calibrated Drill Angled Large
FUSION ORTHOPEDICS, LLC
CD-TM-3150
In Commercial Distribution

  • 00852164007650 ()
CD-01-6133

  • Cannulated surgical drill bit, single-use, non-sterile

HammerTech - 00852164007643

HT Ti Calibrated Drill Angled Medium
FUSION ORTHOPEDICS, LLC
CD-TM-3140
In Commercial Distribution

  • 00852164007643 ()
CD-01-6129

  • Cannulated surgical drill bit, single-use, non-sterile

HammerTech - 00852164007636

HT Ti Calibrated Drill Angled Small
FUSION ORTHOPEDICS, LLC
CD-TM-3130
In Commercial Distribution

  • 00852164007636 ()
CD-01-6127

  • Cannulated surgical drill bit, single-use, non-sterile
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