FDA UDI
In Commercial Distribution
🇺🇸 United States
Fischer-USA
DI: 00860010356203
·
Model: NCI (Box of 10)
·
Fischer Surgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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
- Fischer-USA
- Primary DI
- 00860010356203
- Version / Model
- NCI (Box of 10)
- Catalog Number
- 9288
- Company Name
- Fischer Surgical, Inc.
- Labeler DUNS
- 027019860
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2023-10-13
- Public Version
- 1
- Public Version Date
- 2023-10-23
- Public Version Status
- New
- Public Device Record Key
- b10b6a3d-3112-446c-93b0-ead290c8ced2
Device Description
NCI Spatula (Box of 10)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OTZ | Graft Insertion Instrument For Endothelial Keratoplasty | Ophthalmic | 886.4300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48161 | Donor cornea delivery set | A collection of sterile devices designed to hold and deliver prepared donor endothelial tissue for transplantation into a recipient eye following the removal of Descemet's membrane and dysfunctional endothelium from the patient's cornea during ophthalmic surgery. It typically consists of a preparation base, a cartridge which holds the tissue in a double-coil preventing the surfaces/edges from folding and touching, and an introducer to manually position the cartridge from where the tissue is glided into the eye in correct orientation to unfold. This set is only used for partial replacement of dysfunctional corneal cell layers and not for total cornea replacement. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860010356203 | GS1 | ||||
| Unit of Use | 00860010356265 | GS1 |
Customer Contacts
- Phone
- 314-303-7753
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110734 | 000 |