AccessGUDID - DEVICE: SIREN SGT (00860002701363)

GUDID

Device Identifier (DI) Information

Brand Name: SIREN SGT
Version or Model: SGT-36
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SGT-36
Company Name: TOOLS FOR SURGERY, LLC

Primary DI Number: 00860002701363
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 841842441 *Terms of Use

Device Description: Suction-regulated orogastric calibration tube, 36 Fr

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?
38561	Nasogastric/orogastric tube	A sterile, hollow cylinder that can be introduced into the gastrointestinal (GI) tract both nasally and orally for feeding and/or aspiration. It is made of plastic or rubber and is available in a variety of designs and lengths. Some types are a simple rubber tube with a glass window; other types can be radiopaque to assist accurate placement, have multiple flow-through eyes, and dual connectors (e.g., one for suction and the other for irrigation/feeding). Other uses can be to decompress the stomach, withdraw specimens for diagnostic analysis, administer medications, and for irrigation of the stomach to treat upper gastrointestinal (UGI) bleeding. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNT	Tubes, Gastrointestinal (And Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220218	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
Outer Diameter: 12 Millimeter

Device Record Status

Public Device Record Key: f9a09409-0605-4bab-9acf-f2a634daeb72
Public Version Date: July 25, 2023
Public Version Number: 1
DI Record Publish Date: July 17, 2023