FDA UDI
In Commercial Distribution
🇺🇸 United States
AED Hystero Sheath Double Seal Leur Cap
DI: 00848657076241
·
Model: HYST01
·
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AED Hystero Sheath Double Seal Leur Cap
- Primary DI
- 00848657076241
- Version / Model
- HYST01
- Catalog Number
- HYST01
- Company Name
- NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- Labeler DUNS
- 839138955
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-05
- Public Version
- 3
- Public Version Date
- 2024-07-25
- Public Version Status
- Update
- Public Device Record Key
- fd66c535-dc29-417f-b25f-928d5ee797c2
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | 884.1690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64366 | Endoscope working-channel valve, reusable | A device in the form of a small attachment intended to be fitted to the working channel (including biopsy port) of an endoscope to enable access for, and/or exchange of, an endoscopic device while minimizing leakage of liquids and gasses during an endoscopic procedure. Also referred to as a seal, it may be Luer formatted and include features to allow for simultaneous irrigation/biopsy or suction via the working channel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00848657076241 | GS1 |
Customer Contacts
- Phone
- (818) 227-2720
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141515 | 000 |