DANNIK PI0280

GUDID 00850013527953

DANNIK 10mm Poly Specimen Retrieval System, 280mL

Dannik LLC

Tissue extraction bag introducer

• Primary Device ID: 00850013527953
• NIH Device Record Key: 8bdcd95b-5668-4f3d-ab5a-661e0349987b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DANNIK
• Version Model Number: PI0280
• Catalog Number: PI0280
• 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	00850013527953 [Unit of Use]
GS1	10850013527950 [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

On-Brand Devices [DANNIK]

• 00850013527359: Disposable Monopolar 5mm x 33cm Curved Maryland Dissector, Non-Ratcheting
• 00850013527342: Disposable Monopolar 5mm x 33cm Babcock Grasper, Ratcheting
• 00850013527069: Disposable Monopolar 5mm x 33cm Curved Maryland Dissector, Ratcheting
• 00850013527052: Disposable Monopolar 5mm x 33cm Maxi Grip Fenestrated Grasper, Ratcheting
• 00850013527045: Disposable Monopolar 5mm x 33cm Autraumatic Fenestrated Grasper, Ratcheting
• 00850013527038: Disposable Monopolar 5mm x 33cm Scissor, Fully Insulated
• 00850013527953: DANNIK 10mm Poly Specimen Retrieval System, 280mL