AccessGUDID - DEVICE: Subretinal injection needle 27G tapered to 38G complete with handpiece (08052276026767)

GUDID

Device Identifier (DI) Information

Brand Name: Subretinal injection needle 27G tapered to 38G complete with handpiece
Version or Model: AK-0468.27
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AK-0468.27
Company Name: AKTIVE SRL

Primary DI Number: 08052276026767
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 433533053 *Terms of Use

Device Description: Subretinal injection needle 27G tapered to 38G complete with handpiece

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?
47365	Ophthalmic working-channel cannula, single-use	A sterile rigid tube designed to create a channel through the sclera for internal ocular access during posterior segment ophthalmic surgery. It is typically made of plastic materials or high-grade stainless steel and enables the introduction of ophthalmic surgical instruments; it may also be used for irrigation (i.e., the infusion of fluids to maintain the interior pressure of the eye during surgery). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMX	Cannula, 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
Storage Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: GAUGE

Device Record Status

Public Device Record Key: fb7c3e90-d058-4b54-b6e9-f9752b32fbe8
Public Version Date: January 19, 2024
Public Version Number: 1
DI Record Publish Date: January 11, 2024