FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable EVA Gravity Input Set
DI: 08717872019468
·
Model: 8110.INP01
·
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- Disposable EVA Gravity Input Set
- Primary DI
- 08717872019468
- Version / Model
- 8110.INP01
- Catalog Number
- 8110.INP01
- Company Name
- D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Labeler DUNS
- 407522184
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 6
- Public Version Date
- 2021-03-15
- Public Version Status
- Update
- Public Device Record Key
- 76eb7efe-9119-4f75-b06d-abe768aba0a6
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
- 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 |
|---|---|---|---|---|
| HQC | Unit, Phacofragmentation | Ophthalmic | 886.4670 | 2 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | Ophthalmic | 886.4150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47625 | Surgical irrigation/aspiration tubing set | A collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08717872019468 | GS1 | ||||
| Unit of Use | 18717872019465 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190875 | 000 |