AccessGUDID - DEVICE: LEM (08033638802328)

GUDID

Device Identifier (DI) Information

Brand Name: LEM
Version or Model: Suction LEM with bands
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A.5650.3
Company Name: SAPI MED SPA

Primary DI Number: 08033638802328
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 437320088 *Terms of Use

Device Description: LEM - Disposable haemorrhoid banding ligator for use with suction complete with 3 latex bands.

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
35157	Haemorrhoid ligator	A hand-held manual surgical instrument designed to deploy a ligature (e.g., a latex rubber band) to internal haemorrhoids for their removal through blood flow occlusion. It is typically made of high-grade stainless steel, and has a long shaft with a profiled clamp or grip at the distal end for holding multiple ligatures. The surgeon mechanically operates the distal clamp or grip with a handle(s) to release and deploy the ligatures as needed. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FHN	Ligator, Hemorrhoidal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070881	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: e26e9ddd-64e8-46f7-8d03-afe1d16eb3f4
Public Version Date: August 04, 2023
Public Version Number: 1
DI Record Publish Date: July 27, 2023