AccessGUDID - DEVICE: Sterile, Single Use, Manipulator Sinskey 0, 7mm Altitude, Tip 0, 2mm, 110mm (05404027421858)

GUDID

Device Identifier (DI) Information

Brand Name: Sterile, Single Use, Manipulator Sinskey 0, 7mm Altitude, Tip 0, 2mm, 110mm
Version or Model: 654120
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Hasa Optix

Primary DI Number: 05404027421858
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 371290408 *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):	No
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?
64301	Ophthalmic curette, single-use	A hand-held, manual, ophthalmic surgical instrument typically with a fenestrated, spoon-shaped or ring-like tip which can be either sharp or blunt, intended to be used to obtain or remove eye tissue through a scraping action. It is typically made of metal. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HND	Spatula, ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: Keep dry; Keep away form the sunlight, storage temperature 0-40°C,
Storage Environment Temperature: between 0 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4fbbf4b5-b0f8-473a-9fc6-02d6f14c7259
Public Version Date: July 30, 2024
Public Version Number: 1
DI Record Publish Date: July 22, 2024