AccessGUDID - DEVICE: TROCAR INTRODUCER FOR LTF 5 MM SCOPE (04953170316159)

GUDID

Device Identifier (DI) Information

Brand Name: TROCAR INTRODUCER FOR LTF 5 MM SCOPE
Version or Model: MAJ-1379
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170316159
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: MAJ-1379 TROCAR INTRODUCER FOR LTF 5MM S

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:	No
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?
37142	Endoscopic-access dilator, reusable	A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery
HET	LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
NWB	Endoscope, Accessories, Narrow Band Spectrum

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201832	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization
Ethylene Oxide
High-level Disinfectant

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: c714837c-0144-42eb-af10-1e9d6ca01fd6
Public Version Date: April 22, 2024
Public Version Number: 9
DI Record Publish Date: September 21, 2016