AccessGUDID - DEVICE: Surgeon's Choice Card (00845819006009)

GUDID

Device Identifier (DI) Information

Brand Name: Surgeon's Choice Card
Version or Model: SCK 1000, B-SCK 1000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OASIS MEDICAL, INC.

Primary DI Number: 00845819006009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 194121018 *Terms of Use

Device Description: Kit Packs Assembled from Non-Sterile Capped Product 1 eaches of Cystotome, Angled, 25g x 5/8"(0.5 x 16mm) (GTIN: 00845819001493) 1 eaches of Cortical Cleaving Hydrodissector, 27g x 7/8" (0.4 x 22mm), 11mm Bend, Round End (GTIN: 00845819005958) 1 eaches of Cortical Cleaving Hydrodissector, 27g x 7/8" (0.4 x 22mm), Flat End, 11mm Bend (GTIN: 00845819005989) 1 eaches of Sideport Knives, Safety Line, Thin Slit, Safety Line (Single Bevel Blade) (GTIN: 00845819005675)

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?
46840	Ophthalmic cannulation set, single-use	A collection of non-powered devices intended to be used to create a channel into the eye for posterior segment ophthalmic surgery [e.g., infusion and/or aspiration of an ophthalmic replacement medium (e.g., silicone oil)]. It consists of metal cannulae, often with tubing, and includes additional ophthalmic instruments/devices intended to support the cannulation procedure (e.g., a trocar, plug, syringe, filter); it may be used in conjunction with a dedicated pump (not included) for pressure-controlled fluid delivery. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PZG	Surgical Eye Tray

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: Yes

Sterilization Method [?]
Radiation Sterilization

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: f29c30da-12ad-48d4-b154-ebc01f29a4c9
Public Version Date: July 10, 2023
Public Version Number: 1
DI Record Publish Date: June 30, 2023