AED Hystero Sheath Double Seal Leur Cap HYST01

GUDID 00848657076241

Hystro Sheath Double Seal Luer Cap is intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure.

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Endoscopic biopsy valve, reusable

• Primary Device ID: 00848657076241
• NIH Device Record Key: fd66c535-dc29-417f-b25f-928d5ee797c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AED Hystero Sheath Double Seal Leur Cap
• Version Model Number: HYST01
• Catalog Number: HYST01
• 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
• 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	00848657076241 [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

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

[00848657076241]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-03-19
• Device Publish Date: 2020-11-05

Devices Manufactured by NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

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• 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