AccessGUDID - DEVICE: ClearCap Distal Attachment (08809327350636)

GUDID

Device Identifier (DI) Information

Brand Name: ClearCap Distal Attachment
Version or Model: FM-EC0007
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FINEMEDIX CO.,LTD.

Primary DI Number: 08809327350636
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688256864 *Terms of Use

Device Description: 15.7mm/13.3mm

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?
64014	Endoscope distal observation spacer, single-use	A short, light-penetrating cap designed to be placed onto the distal end of an endoscope (e.g., colonoscope) to facilitate observation, by retaining a short distance between the endoscope tip and lumen wall or other structure of interest. It typically has a small hole to allow fluid drain from inside the cap; it does not have anchoring capabilities (i.e., not an anchoring cuff). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OCX	Endoscopic Irrigation/Suction System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K202616	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: bf1a4f7e-3dde-45ef-a41b-c25536573992
Public Version Date: December 23, 2024
Public Version Number: 4
DI Record Publish Date: March 11, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
18809327350633	10	08809327350636		In Commercial Distribution	Box
28809327350630	50	08809327350636		In Commercial Distribution	Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +82537418388
Email: finemedix@finemedix.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES