SOLOBAG PPI0280

GUDID 00850013527793

PMI SOLOBAG 10mm Poly Specimen Retrieval System, 280mL

Dannik LLC

Tissue extraction bag introducer

• Primary Device ID: 00850013527793
• NIH Device Record Key: 84a84d33-3a8b-4b12-8409-69f03be501be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLOBAG
• Version Model Number: PPI0280
• Catalog Number: PPI0280
• Company DUNS: 117407001
• Company Name: Dannik LLC
• Device Count: 10
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013527793 [Unit of Use]
GS1	10850013527790 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-07
• Device Publish Date: 2025-06-27

Devices Manufactured by Dannik LLC

• 00850013527793 - SOLOBAG: 2025-07-07PMI SOLOBAG 10mm Poly Specimen Retrieval System, 280mL
• 00850013527793 - SOLOBAG: 2025-07-07 PMI SOLOBAG 10mm Poly Specimen Retrieval System, 280mL
• 00850013527953 - DANNIK: 2025-07-07 DANNIK 10mm Poly Specimen Retrieval System, 280mL
• 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