AccessGUDID - DEVICE: Endolumik (G461EGCT36M0)

GUDID

Device Identifier (DI) Information

Brand Name: Endolumik
Version or Model: EGCT36M
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Endolumik, Inc.

Primary DI Number: G461EGCT36M0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117601339 *Terms of Use

Device Description: 36F Endolumik Gastric Calibration Tube, M Series

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?
44686	Gastric calibration tube	A thin, flexible, hollow cylinder with an inflatable balloon at the distal end designed to be inserted into a patient's stomach through the mouth and oesophagus to create and size a gastric pouch typically for a bariatric gastric surgical procedure (e.g., sleeve gastrectomy, gastric banding). The proximal end may include a check valve and connects to a syringe, typically included, intended to inflate the balloon to a predetermined volume; fluid suction/irrigation ports are provided at the distal end. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNT	Tubes, Gastrointestinal (And Accessories)
FAT	Bougie, Esophageal, And Gastrointestinal, Gastro-Urology

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240069	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
Handling Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -18 and 60 Degrees Celsius
Handling Environment Atmospheric Pressure: between 500 and 1060 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 12 Millimeter

Device Record Status

Public Device Record Key: aeefae10-350f-4dd5-8d55-96797744f92a
Public Version Date: August 14, 2024
Public Version Number: 1
DI Record Publish Date: August 06, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
G461EGCT36M1	5	G461EGCT36M0		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: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 304-207-0072
Email: customerservice@endolumik.com

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