FDA UDI
In Commercial Distribution
🇺🇸 United States
Surgeon's Choice Card
DI: 00845819006375
·
Model: SCK 2005, B-SCK 2005
·
OASIS MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Surgeon's Choice Card
- Primary DI
- 00845819006375
- Version / Model
- SCK 2005, B-SCK 2005
- 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
- 2
- Public Version Date
- 2025-01-14
- Public Version Status
- Update
- Public Device Record Key
- b177256a-d3ef-4d8b-880a-a9feeb404737
Device Description
Kit Packs Assembled from Non-Sterile Capped Product: 2 eaches of Hovis Hydrodissection Cannula, 27g x 7/8” 4mm Bend (GTIN: 00845819006368) 1 eaches of Irrigating Cystotome, Formed, 25g x 5/8” (GTIN: 00845819001479) 1 eaches of Cortical Cleaving Hydrodissector, 27g x 7/8" (GTIN: 00845819005958)
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 | 10845819006372 | GS1 | Carton | 20 | In Commercial Distribution | |
| Primary | 00845819006375 | GS1 |
Customer Contacts
- Phone
- 9093055400
- [email protected]