Rad Control

GUDID 00812269033343

15 - 50 GY Irradiation Indicator Tag

TYPENEX MEDICAL LLC

Blood irradiation indicator Blood irradiation indicator Blood irradiation indicator Blood irradiation indicator Blood irradiation indicator Blood irradiation indicator Blood irradiation indicator Blood irradiation indicator Blood irradiation indicator Blood irradiation indicator Blood irradiation indicator Blood irradiation indicator Blood irradiation indicator

• Primary Device ID: 00812269033343
• NIH Device Record Key: 11b86cc7-c098-4100-bdba-6805a0d6050e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rad Control
• Version Model Number: RT0303
• Company DUNS: 600850213
• Company Name: TYPENEX MEDICAL LLC
• Device Count: 200
• 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810050855143 [Unit of Use]
GS1	00812269033343 [Primary]

FDA Product Code

• IWZ: Film, Radiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-01
• Device Publish Date: 2022-11-23

On-Brand Devices [Rad Control]

• 00892159002178: 15 Gy Irradiation Indicator Tag - X Ray
• 00892159002161: 25 Gy Irradiation Indicator Tag - X Ray
• 00892159002154: 15 Gy Irradiation Indicator Tag - Gamma
• 00892159002109: 25 Gy Irradiation Indicator Tag - Gamma
• 00851878008892: 25 Gy Irradiation Indicator Tag - X Ray - Custom One Blood
• 00851878008885: 25 Gy Irradiation Indicator Tag - Gamma - Custom One Blood
• 00812269033374: Irradiation Indicator Tag - Barcode Indicator
• 00812269033350: 25 - 50 GY Irradiation Indicator Tag
• 00812269033343: 15 - 50 GY Irradiation Indicator Tag
• 00812269030014: 25 Gy Irradiation Indicator Tag - X Ray (no sticker)
• 00812269030007: 25 Gy Irradiation Indicator Tag - Gamma (No Sticker)