AccessGUDID - DEVICE: Embrella(TM) Endoscopic Distal Attachment (06932503560818)

GUDID

Device Identifier (DI) Information

Brand Name: Embrella(TM) Endoscopic Distal Attachment
Version or Model: EM-S-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Micro-Tech (Nanjing) Co., Ltd.

Primary DI Number: 06932503560818
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530269083 *Terms of Use

Device Description: The endoscope with a diameter of 11.5-13mm is available. The product is standard type of Embrella™ Endoscopic Distal Attachment .

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":	Yes
For Single-Use:	Yes
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?
60911	Colonoscope distal anchoring cuff	A device in the form of a cuff with concentric finger-like components intended to fit to a flexible colonoscope distal end to stabilize its tip within the colonic lumen and straighten the colonic folds to facilitate observation and/or surgical instrument use. The fingers are intended to open and grip the colon during pull back (exturbation); the device may in addition have a protruding distal end (spacer) intended to maintain distance between the endoscope tip and structures of interest. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FED	Endoscopic Access Overtube, Gastroenterology-Urology

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190030	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: 07a7947d-bfd5-4a6d-b648-46f6ba0f688f
Public Version Date: December 23, 2024
Public Version Number: 4
DI Record Publish Date: December 31, 2021