AccessGUDID - DEVICE: MONARCH DISPOSABLE ANOSCOPE (00613970018922)

GUDID

Device Identifier (DI) Information

Brand Name: MONARCH DISPOSABLE ANOSCOPE
Version or Model: 1891W
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1891W
Company Name: MONARCH MOLDING, INC.

Primary DI Number: 00613970018922
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 007136203 *Terms of Use

Device Description: ONE TIME USE 18mm x 90 mm (WHITE) SLOTTED PLASTIC DISPOSABLE ANOSCOPE 100/EACH PER CASE-50/EACH PER BAG

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:	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?
48081	Haemorrhoid electrotherapy system procedure kit	A collection of devices intended to be used in conjunction with a haemorrhoid management system to facilitate the procedure of electrically eliminating all grades of internal haemorrhoids. It typically includes a tissue contact electrode (a hand-held probe), a grounding pad sponge, and a disposable anoscope. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDM	Sigmoidoscope, Rigid, Non-Electrical

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 6b478051-f37c-4ee8-9137-45dc8ac25434
Public Version Date: January 08, 2021
Public Version Number: 3
DI Record Publish Date: September 14, 2016