FDA UDI
In Commercial Distribution
🇺🇸 United States
Surgeon's Choice Card
DI: 00845819006344
·
Model: SCK 2004, B-SCK 2004
·
OASIS MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Surgeon's Choice Card
- Primary DI
- 00845819006344
- Version / Model
- SCK 2004, B-SCK 2004
- Company Name
- OASIS MEDICAL, INC.
- Labeler DUNS
- 194121018
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-30
- Public Version
- 1
- Public Version Date
- 2023-07-10
- Public Version Status
- New
- Public Device Record Key
- 74e2d630-b822-46dd-8fda-d9d97864b1a4
Device Description
Kit Packs Assembled from Non-Sterile Capped Product: 1 eaches of Olive Tip Capsule Polisher, 25g x 1”, Angled (GTIN: 00845819006337) 1 eaches of Cortex Extractor Cannula, Micro J-Shaped, 25g x 7/8” (GTIN: 00845819006351) 1 eaches of Cortical Cleaving Hydrodissector, 27g x 7/8” (0.4 x 22mm), 11mm Bend, Round End (GTIN: 00845819005958) 1 eaches of Irrigating Cystotome, Formed, 25g x 5/8” (GTIN: 00845819001479)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PZG | Surgical Eye Tray | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10845819006341 | GS1 | Carton | 20 | In Commercial Distribution | |
| Primary | 00845819006344 | GS1 |
Customer Contacts
- Phone
- 9093055400
- [email protected]