NanoPhix Instrument Kit EXINN911500

GUDID B487EXINN9115000

NanoPhix sterile instrument kit. The kit contains 1 depth gauge, 2 guide wires, 1 driver.

Exsomed Corporation

Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use

• Primary Device ID: B487EXINN9115000
• NIH Device Record Key: 39dc9101-6f65-4dd4-954b-137483dcb867
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NanoPhix Instrument Kit
• Version Model Number: EXINN911500
• Catalog Number: EXINN911500
• Company DUNS: 116722111
• Company Name: Exsomed Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B487EXINN9115000 [Primary]

FDA Product Code

• HXI: Passer, Wire, Orthopedic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-18
• Device Publish Date: 2022-11-01

Devices Manufactured by Exsomed Corporation

• B487EXINN9215060 - NanoPhix Implant: 2024-02-01 NanoPhix is a stainless steel bone screw.
• B487EXINN9215070 - NanoPhix Implant: 2024-02-01 NanoPhix is a stainless steel bone screw.
• B487EXINN9215080 - NanoPhix Implant: 2024-02-01 NanoPhix is a stainless steel bone screw.
• B487EXINN9215090 - NanoPhix Implant: 2024-02-01 NanoPhix is a stainless steel bone screw.
• B487EXINN9215100 - NanoPhix Implant: 2024-02-01 NanoPhix is a stainless steel bone screw.
• B487EXINN9215110 - NanoPhix Implant: 2024-02-01 NanoPhix is a stainless steel bone screw.
• B487EXINN9215120 - NanoPhix Implant: 2024-02-01 NanoPhix is a stainless steel bone screw.
• B487EXINN9215130 - NanoPhix Implant: 2024-02-01 NanoPhix is a stainless steel bone screw.