Awl 90-RAA-405000

GUDID 00811714030005

Awl

RESPONSIVE ORTHOPEDICS LLC

Bone awl

• Primary Device ID: 00811714030005
• NIH Device Record Key: 7e58c5a6-d92f-4cc8-b88e-341959453b78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Awl
• Version Model Number: 90-RAA-405000
• Catalog Number: 90-RAA-405000
• 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: false
• 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
GS1	00811714030005 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-31
• Device Publish Date: 2019-05-23

On-Brand Devices [Awl]

• 00811714030005: Awl
• 00811714034362: Awl
• 00811714035475: 5.5 mm Reusable Awl
• 00811714036311: 5.5 mm Reusable Awl
• 00811714036304: Awl