AccessGUDID - DEVICE: STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS) (04573545740046)

GUDID

Device Identifier (DI) Information

Brand Name: STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)
Version or Model: VLDS-32009
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TSK LABORATORY INTERNATIONAL JAPAN K.K.

Primary DI Number: 04573545740046
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 717605253 *Terms of Use

Device Description: No description.

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?
47610	Ophthalmic needle, single-use	A slender, straight hollow instrument, usually with a sharp bevelled end, designed to be used with a syringe for the transient delivery of fluid materials (e.g., anaesthetic agents, therapeutic drugs) to various structures in and around the eye, including the eye muscles, or to an intraocular implant; it may also be intended for aspiration (e.g., aqueous humour). It is made of metal and/or plastic materials and may include a needle positioning and perforation depth guide. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QYM	Ophthalmic Needle

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K242073	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: 942e0e61-a49c-4518-b272-0fe0f563a78d
Public Version Date: July 22, 2025
Public Version Number: 1
DI Record Publish Date: July 14, 2025