AccessGUDID - DEVICE: Tube Sheath (04953170044946)

GUDID

Device Identifier (DI) Information

Brand Name: Tube Sheath
Version or Model: MAJ-253
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170044946
Issuing Agency: GS1
Commercial Distribution End Date: August 10, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: MAJ-253 TEFLON SHEATH FOR HX-20U-1 LOOP

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?
36176	Polypectomy endoscopic ligator, reusable	A device used in combination with a compatible flexible endoscope for the deployment of a ligature loop (a self-locking device made of, e.g., a polymer in the form of a thin band) that is typically applied to large colorectal or pedunculated polyps in the gastrointestinal (GI) tract to prevent or control bleeding following polypectomy. It typically consists of an insertion sheath, the ligature loop at the distal end, and a control handle at the proximal end used to deploy the loop. This device may be used to ligate the appendix during its removal. This is a reusable device.	Active	false

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: 94f4a5c8-baca-4be2-b0d4-48b45f119aee
Public Version Date: August 11, 2022
Public Version Number: 6
DI Record Publish Date: September 21, 2016