AccessGUDID - DEVICE: Loop (04953170045028)

GUDID

Device Identifier (DI) Information

Brand Name: Loop
Version or Model: MAJ-340
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170045028
Issuing Agency: GS1
Commercial Distribution End Date: August 10, 2022
Device Count: 10
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: MAJ-340 20MM DETACHABLE NYLON LOOP 10/BX

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?
17785	Endoscopic ligature loop	A device that is used to constrict a protruding tissue, e.g., a varix or a polyp to prevent or control bleeding following, e.g., a polypectomy, thereby creating a haemostasis or necrosis during an endoscopic procedure. It is applied using a dedicated endoscopic ligator. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MND	Ligator, esophageal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: d8f92d0e-3b67-4693-9f3a-4c7eba2b7ac6
Public Version Date: August 11, 2022
Public Version Number: 4
DI Record Publish Date: September 21, 2016