AccessGUDID - DEVICE: Orbit Subretinal Delivery System (00860000540513)

GUDID

Device Identifier (DI) Information

Brand Name: Orbit Subretinal Delivery System
Version or Model: PN1007128-002C
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Gyroscope Usa, Inc.

Primary DI Number: 00860000540513
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071418804 *Terms of Use

Device Description: Subretinal Access Kit - Curved

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:	Yes
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?
45150	Ophthalmic surgical procedure kit, non-medicated, single-use	A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMX	Cannula, Ophthalmic
FMF	Syringe, Piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182274	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: cb0d3660-f4d2-482c-9710-ad3e9bb4cb75
Public Version Date: October 06, 2020
Public Version Number: 3
DI Record Publish Date: April 30, 2019