FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Kit for subretinal injection of BSS
DI: 08717872025988
·
Model: 1364.DD
·
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
- Kit for subretinal injection of BSS
- Primary DI
- 08717872025988
- Version / Model
- 1364.DD
- Catalog Number
- 1364.DD
- Company Name
- D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Labeler DUNS
- 407522184
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2016-09-30
- Public Version
- 9
- Public Version Date
- 2022-04-12
- Public Version Status
- Update
- Public Device Record Key
- c6259458-95ca-4b6d-acd9-1ea40f821dc0
- Distribution End Date
- 2017-07-04
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 |
|---|---|---|---|---|
| 46705 | Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use | A rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08717872025988 | GS1 | ||||
| Unit of Use | 18717872025985 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142877 | 000 |