SUPERBAG PNI0140

GUDID 00850013527601

PMI SuperBag 5 Small Specimen Retrieval System, 140mL

Dannik LLC

Tissue extraction bag introducer

• 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

• 00850013527397 - PMI LAPSYSTEM™: 2024-10-31 PMI LAPSYSTEM™ Disposable Laparoscopic Scissor, 33cm Shaft with Curved Mini-Metz Scissor Tip, Monopolar
• 00850013527410 - PMI LAPSYSTEM™: 2024-10-31 PMI LAPSYSTEM™ Disposable Laparoscopic Dissector, 33cm Shaft with Curved Maryland Dissector Tip, Monopolar, Ratcheting
• 00850013527441 - PMI LAPSYSTEM™: 2024-10-31 PMI LAPSYSTEM™ Disposable Laparoscopic Grasper, 33cm Shaft with Babcock Grasper Tip, Monopolar, Ratcheting
• 00850013527809 - PMI LAPSYSTEM™: 2024-10-31 PMI LAPSYSTEM™ Disposable Laparoscopic Grasper, 33cm Shaft with Atraumatic Fenestrated Grasper Tip, Monopolar, Ratcheting
• 00850013527038 - Dannik: 2024-08-07 Disposable Monopolar 5mm x 33cm Scissor, Fully Insulated
• 00850013527045 - Dannik: 2024-08-07 Disposable Monopolar 5mm x 33cm Autraumatic Fenestrated Grasper, Ratcheting
• 00850013527052 - Dannik: 2024-08-07 Disposable Monopolar 5mm x 33cm Maxi Grip Fenestrated Grasper, Ratcheting
• 00850013527069 - Dannik: 2024-08-07 Disposable Monopolar 5mm x 33cm Curved Maryland Dissector, Ratcheting