AccessGUDID - DEVICE: NA (10888551010948)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: ETHB5LP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ETHB5LP
Company Name: STERILMED, INC.

Primary DI Number: 10888551010948
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: TROCAR BLADELESS ENDOPATH XCEL W/SMOOTH SLEEVE

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 It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity.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 [?]
K052299	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: 679df27e-7802-44a4-989f-11f05830df00
Public Version Date: February 14, 2025
Public Version Number: 7
DI Record Publish Date: September 22, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: +1(888)541-0078
Email: sterilmedcs@its.jnj.com

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