SUPERBAG PNI0140

GUDID 00850013527601

PMI SuperBag 5 Small Specimen Retrieval System, 140mL

Dannik LLC

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• Primary Device ID: 00850013527601
• NIH Device Record Key: 6f100bf5-eba0-4b35-bfd3-d740e11bc693
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUPERBAG
• Version Model Number: NI0140
• Catalog Number: PNI0140
• Company DUNS: 117407001
• Company Name: Dannik LLC
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	00850013527601 [Unit of Use]
GS1	10850013527608 [Primary]

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-08-01
• Device Publish Date: 2023-01-21

Devices Manufactured by Dannik LLC

• 00850013527502 - EXTEND: 2024-02-23 Extend 10mm Specimen Retrieval System, 240mL
• 00850013527601 - SUPERBAG: 2023-08-01PMI SuperBag 5 Small Specimen Retrieval System, 140mL
• 00850013527601 - SUPERBAG: 2023-08-01 PMI SuperBag 5 Small Specimen Retrieval System, 140mL