Large Biopsy Cup Forcep, D/A MH1485

GUDID 00848657076685

A flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination.

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Flexible endoscopic biopsy forceps, reusable

• Primary Device ID: 00848657076685
• NIH Device Record Key: db26c8e2-0001-43d2-af5f-f564013d5255
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Large Biopsy Cup Forcep, D/A
• Version Model Number: MH1485
• Catalog Number: MH1485
• Company DUNS: 839138955
• Company Name: NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
• Device Count: 1
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (818) 227-2720
• Email: customerservice@aed.md
• Phone: (818) 227-2720
• Email: customerservice@aed.md
• Phone: (818) 227-2720
• Email: customerservice@aed.md
• Phone: (818) 227-2720
• Email: customerservice@aed.md
• Phone: (818) 227-2720
• Email: customerservice@aed.md
• Phone: (818) 227-2720
• Email: customerservice@aed.md
• Phone: (818) 227-2720
• Email: customerservice@aed.md
• Phone: (818) 227-2720
• Email: customerservice@aed.md
• Phone: (818) 227-2720
• Email: customerservice@aed.md
• Phone: (818) 227-2720
• Email: customerservice@aed.md
• Phone: (818) 227-2720
• Email: customerservice@aed.md
• Phone: (818) 227-2720
• Email: customerservice@aed.md
• Phone: (818) 227-2720
• Email: customerservice@aed.md
• Phone: (818) 227-2720
• Email: customerservice@aed.md
• Phone: (818) 227-2720
• Email: customerservice@aed.md

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848657076685 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141515

FDA Product Code

• HIH: Hysteroscope (And Accessories)

Sterilization

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

[00848657076685]

Moist Heat or Steam Sterilization

[00848657076685]

Moist Heat or Steam Sterilization

[00848657076685]

Moist Heat or Steam Sterilization

[00848657076685]

Moist Heat or Steam Sterilization

[00848657076685]

Moist Heat or Steam Sterilization

[00848657076685]

Moist Heat or Steam Sterilization

[00848657076685]

Moist Heat or Steam Sterilization

[00848657076685]

Moist Heat or Steam Sterilization

[00848657076685]

Moist Heat or Steam Sterilization

[00848657076685]

Moist Heat or Steam Sterilization

[00848657076685]

Moist Heat or Steam Sterilization

[00848657076685]

Moist Heat or Steam Sterilization

[00848657076685]

Moist Heat or Steam Sterilization

[00848657076685]

Moist Heat or Steam Sterilization

[00848657076685]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-17
• Device Publish Date: 2023-10-09

Devices Manufactured by NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

• 00848657023122 - AED: 2026-02-02 AED Flexible Grasping Forcep, 3Fr x 100cm, D/A
• 00848657023139 - AED: 2026-02-02 AED Flexible Grasping Forcep, 3Fr x 28cm, D/A
• 00848657068956 - AED: 2026-02-02 AED Flexible Grasper Forceps, 5Fr x 40cm, D/A
• 00848657069236 - AED: 2026-02-02 AED Flexible Biopsy Grasper, 0.9mm x 45cm, D/A
• 00848657069243 - AED: 2026-02-02 AED Flexible Biopsy Punch, 5FR x 30cm, S/A
• 00848657069250 - AED: 2026-02-02 AED Flexible Biopsy Grasper, 5Fr x 30cm, D/A
• 00848657069618 - AED: 2026-02-02 AED Flexible Scissor Forcep, 5FR x 47cm, S/A
• 00848657074889 - AED: 2026-02-02 AED Flexible Scissor Forcep, 5Fr x 40cm, S/A