CSR Wraps

GUDID 00616784441535

DYNAREX CORPORATION

Sterilization packaging, single-use

• Primary Device ID: 00616784441535
• NIH Device Record Key: e59cd13a-6e77-47b4-ad7e-bfa0d8b802f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CSR Wraps
• Version Model Number: 4415
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 500
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Expiration Date: true
• 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	00616784441511 [Unit of Use]
GS1	00616784441528 [Primary]
GS1	00616784441535 [Package]; Contains: 00616784441528; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062100

FDA Product Code

• FRG: Wrap, Sterilization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-24

On-Brand Devices [CSR Wraps]

• 00616784447230: 4472
• 00616784445434: 4454
• 00616784444833: 4448
• 00616784444536: 4445
• 00616784444031: 4440
• 00616784443638: 4436
• 00616784443034: 4430
• 00616784442433: 4424
• 00616784442037: 4420
• 00616784441535: 4415
• 00616784441238: 4412