Packing Strip

GUDID 00616784340227

Packing Strip, Plain, Sterile, 1/2" x 5 yd. (13mm x 4.6m)

DYNAREX CORPORATION

Gauze strip, non-antimicrobial

• Primary Device ID: 00616784340227
• NIH Device Record Key: c447cdd7-ec04-49cc-a5bf-64be9c54ede3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Packing Strip
• Version Model Number: 3402
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 1
• 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: 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	00616784340227 [Primary]
GS1	00616784340234 [Package]; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012816

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2022-05-03
• Device Publish Date: 2022-04-25

On-Brand Devices [Packing Strip]

• 00616784340425: Packing Strip, Plain, Sterile, 2" x 5 yd. (50.08 mm x 4.6 m)
• 00616784340326: Packing Strip, Plain, Sterile, 1" x 5 yd. (25.4mm x 4.6m)
• 00616784340227: Packing Strip, Plain, Sterile, 1/2" x 5 yd. (13mm x 4.6m)
• 00616784340128: Packing Strip, Plain, Sterile, 1/4" x 5 yd. (6mm x 4.6m)