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.
00845819006009
GS1

1
194121018 *Terms of Use
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)
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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
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FDA Product Code

[?]
Product Code Product Code Name
PZG Surgical Eye Tray
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FDA Premarket Submission

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

Sterilization

Yes
Yes
Sterilization Method [?]
Radiation Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

f29c30da-12ad-48d4-b154-ebc01f29a4c9
July 10, 2023
1
June 30, 2023
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
9093055400
customerservice@oasismedical.com
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