Shadow Knotless 920002-0000-P

GUDID 00811714035888

Shadow Knotless Instruments

RESPONSIVE ORTHOPEDICS LLC

Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable

• Primary Device ID: 00811714035888
• NIH Device Record Key: 4b5290ef-5577-4475-8224-85af6b778b6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shadow Knotless
• Version Model Number: 920002-0000-P
• Catalog Number: 920002-0000-P
• Company DUNS: 002745858
• Company Name: RESPONSIVE ORTHOPEDICS LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
GS1	00811714035888 [Primary]

FDA Product Code

• FSM: Tray, Surgical, Instrument

Sterilization

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

[00811714035888]

Moist Heat or Steam Sterilization

[00811714035888]

Moist Heat or Steam Sterilization

[00811714035888]

Moist Heat or Steam Sterilization

[00811714035888]

Moist Heat or Steam Sterilization

[00811714035888]

Moist Heat or Steam Sterilization

[00811714035888]

Moist Heat or Steam Sterilization

[00811714035888]

Moist Heat or Steam Sterilization

[00811714035888]

Moist Heat or Steam Sterilization

[00811714035888]

Moist Heat or Steam Sterilization

[00811714035888]

Moist Heat or Steam Sterilization

[00811714035888]

Moist Heat or Steam Sterilization

[00811714035888]

Moist Heat or Steam Sterilization

[00811714035888]

Moist Heat or Steam Sterilization

[00811714035888]

Moist Heat or Steam Sterilization

[00811714035888]

Moist Heat or Steam Sterilization

[00811714035888]

Moist Heat or Steam Sterilization

[00811714035888]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-14
• Device Publish Date: 2023-11-06

Devices Manufactured by RESPONSIVE ORTHOPEDICS LLC

• 00811714035994 - Stealth: 2024-04-09 Stealth Drill 3.0mm
• 00811714036007 - Stealth: 2024-04-09 Stealth Castle Guide Tube
• 00811714036014 - Stealth: 2024-04-09 Stealth Soft Bone Drill 3.0mm
• 00811714036021 - Stealth: 2024-04-09 Stealth Probe
• 00811714036038 - Stealth: 2024-04-09 Stealth Blunt Probe
• 00811714036045 - Mini Stealth: 2024-04-09 Mini Stealth Drill 2.1mm
• 00811714036052 - Mini Stealth: 2024-04-09 Mini Stealth Castle Guide Tube
• 00811714036069 - Mini Stealth: 2024-04-09 Mini Stealth Probe