AccessGUDID - DEVICE: AED Hystero Sheath Double Seal Leur Cap (00848657076241)

GUDID

Device Identifier (DI) Information

Brand Name: AED Hystero Sheath Double Seal Leur Cap
Version or Model: HYST01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HYST01
Company Name: NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Primary DI Number: 00848657076241
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 839138955 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIH	Hysteroscope (And Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141515	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fd66c535-dc29-417f-b25f-928d5ee797c2
Public Version Date: July 25, 2024
Public Version Number: 3
DI Record Publish Date: November 05, 2020