DEVICE: Surgeon's Choice Card (00845819006009)
Device Identifier (DI) Information
Surgeon's Choice Card
SCK 1000, B-SCK 1000
In Commercial Distribution
OASIS MEDICAL, INC.
SCK 1000, B-SCK 1000
In Commercial Distribution
OASIS MEDICAL, INC.
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
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
f29c30da-12ad-48d4-b154-ebc01f29a4c9
July 10, 2023
1
June 30, 2023
July 10, 2023
1
June 30, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10845819006006 | 12 | 00845819006009 | In Commercial Distribution | Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
9093055400
customerservice@oasismedical.com
customerservice@oasismedical.com