AccessGUDID - DEVICE: OcuSafe-XL Ophthalmic Needle (00850037925629)

GUDID

Device Identifier (DI) Information

Brand Name: OcuSafe-XL Ophthalmic Needle
Version or Model: PN0403-15
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ocuject, LLC

Primary DI Number: 00850037925629
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017559643 *Terms of Use

Device Description: The OcuSafe® LDS Needles are designed to provide a means of fluid injection and aspiration. The devices are single-lumen needles intended for use with a luer-tip syringe. The Low Dead Space (LDS) needle has a decreased internal volume within the luer taper to reduce fluid volume loss. The OcuSafe® LDS Needles have a removable cap that is removed prior to the needle’s use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The OcuSafe® LDS Needles are single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The OcuSafe® LDS Needles are suitable for intravitreal use.

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?
59230	Hypodermic needle, single-use	A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QNS	Low Dead Space Needle, Single Lumen, Hypodermic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K242956	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: 798a785b-4f3c-435c-8d88-2bf932d99b62
Public Version Date: December 24, 2024
Public Version Number: 1
DI Record Publish Date: December 16, 2024