AccessGUDID - DEVICE: NA (10888551010856)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: ETH355DA
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ETH355DA
Company Name: STERILMED, INC.

Primary DI Number: 10888551010856
Issuing Agency: GS1
Commercial Distribution End Date: February 14, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 175899459 *Terms of Use

Device Description: ENDOPATH RESPOSABLE DILATING TIP OBTURATOR AND HOUSING

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?
61814	Laparoscopic trocar blade, reprocessed	A rigid surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. This is a previously used single-use device that has been processed for an additional single-use patient application.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NLM	LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K043592	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: 354ae176-1fa7-4fe7-8677-35964fda1415
Public Version Date: February 14, 2025
Public Version Number: 7
DI Record Publish Date: September 22, 2016