Rosen Inserter

GUDID 09421901970895

ADEPT MEDICAL LIMITED

Tympanostomy tube inserter, single-use Tympanostomy tube inserter, single-use Tympanostomy tube inserter, single-use Tympanostomy tube inserter, single-use Tympanostomy tube inserter, single-use Tympanostomy tube inserter, single-use Tympanostomy tube inserter, single-use Tympanostomy tube inserter, single-use Tympanostomy tube inserter, single-use Tympanostomy tube inserter, single-use Tympanostomy tube inserter, single-use

• Primary Device ID: 09421901970895
• NIH Device Record Key: 82e63b06-889d-4400-b7a3-ac1262627755
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rosen Inserter
• Version Model Number: NZ3461-100
• Company DUNS: 592534619
• Company Name: ADEPT MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	09421901970895 [Primary]

FDA Product Code

• JYH: Excavator, Ear

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-01
• Device Publish Date: 2024-04-23

Devices Manufactured by ADEPT MEDICAL LIMITED

• 09421901970475 - Cerumen Hook: 2024-05-01
• 09421901970802 - Jobson Horne Probe - Oval: 2024-05-01
• 09421901970819 - Jobson Horne Probe - Oval, Sterile: 2024-05-01
• 09421901970895 - Rosen Inserter: 2024-05-01
• 09421901970895 - Rosen Inserter: 2024-05-01
• 09421901970970 - Micro Ear Forceps, Stainless Steel, 4 mm Jaw, Ultra Fine, Non-Sterile: 2024-05-01
• 09421902825026 - Micro Ear Forceps, Stainless Steel, 4 mm Jaw, Non-Sterile: 2024-05-01
• 09421902825118 - Micro Ear Forceps, Stainless Steel, 7 mm Jaw, Non-Sterile: 2024-05-01
• 09421902825255 - Tilley Nasal Forcep, 140 mm Non-Sterile: 2024-05-01