FDA UDI
In Commercial Distribution
🇺🇸 United States
Procedure Pack
DI: 07640167750337
·
Model: 8.5 LCS
·
SIE AG, Surgical Instrument Engineering
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Procedure Pack
- Primary DI
- 07640167750337
- Version / Model
- 8.5 LCS
- Catalog Number
- 510.701.187
- Company Name
- SIE AG, Surgical Instrument Engineering
- Labeler DUNS
- 482163628
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-14
- Public Version
- 2
- Public Version Date
- 2019-11-08
- Public Version Status
- Update
- Public Device Record Key
- 49046181-71ff-421d-8d1e-bed5276bbf50
Device Description
Procedure Pack LCS Ø 8.5mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| HNO | Keratome, Ac-Powered | Ophthalmic | 886.4370 | 1 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45150 | Ophthalmic surgical procedure kit, non-medicated, single-use | A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07640167750870 | GS1 | Carton | 10 | In Commercial Distribution | |
| Primary | 07640167750337 | GS1 |
Customer Contacts
- Phone
- 8667084490
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K053511 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 8.5 | Millimeter |