AccessGUDID - DEVICE: Transport Endoscopic Access Device (00860009064751)

GUDID

Device Identifier (DI) Information

Brand Name: Transport Endoscopic Access Device
Version or Model: Transport-R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 500100
Company Name: Usgi Medical, Inc.

Primary DI Number: 00860009064751
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 112331090 *Terms of Use

Device Description: Transport Endoscopic Access Device

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):	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?
60438	Multichannel gastrointestinal endoscopic guide, steerable	A sterile, steerable, multi-luminal, flexible tube intended to function as a housing for a compatible flexible endoscope and endoscopic tool(s), to facilitate introduction of the endoscope, and provide independent working channels (i.e., not through the endoscope) for the flexible endoscopic tool(s) during procedures of the upper gastrointestinal (GI) tract (e.g., placement of tissue anchors). It includes proximal ports and controls to steer the distal end, and may assist in the repeated advancement and withdrawal of the endoscope or endoscopic devices. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FED	Endoscopic Access Overtube, Gastroenterology-Urology
ODB	Endoscopic Contamination Prevention Sheath

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K072405	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: 4fa9b8f7-797c-4fd4-95ef-092f4f290f2f
Public Version Date: December 28, 2022
Public Version Number: 1
DI Record Publish Date: December 20, 2022