FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Pneumatic Vitrectome.(23 gauge / 0.6 mm)(working with 37 P.S.I., max.
DI: 08717872008578
·
Model: 2267.NMD06
·
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- Disposable Pneumatic Vitrectome.(23 gauge / 0.6 mm)(working with 37 P.S.I., max.
- Primary DI
- 08717872008578
- Version / Model
- 2267.NMD06
- Catalog Number
- 2267.NMD06
- 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
- 2016-09-30
- Public Version
- 4
- Public Version Date
- 2019-02-15
- Public Version Status
- Update
- Public Device Record Key
- 5ec89e53-bb61-4ff3-b8be-46b02bfc1d49
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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47787 | Ophthalmic surgical instrument handle, pneumatic | A sterile, hand-held, pneumatically-powered device designed to hold and operate a compatible ophthalmic surgical instrument tip (e.g., scissors, forceps). It is typically in the form of a conventional handle with a connector that secures the inserted tip, and has a pneumatic feedline (tubing) that connects to a parent device with gas source; when gas is supplied to the handle, typically using a foot-switch, a mechanism is activated to operate the inserted tip (e.g., opens and closes blades). It is typically used for surgery in the anterior or the posterior segment to cut, grasp, and manipulate eye tissue. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08717872008578 | GS1 | ||||
| Unit of Use | 18717872008575 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K081877 | 000 |