FDA UDI
In Commercial Distribution
🇺🇸 United States
MICROKERATOME Disposable Tubing
DI: 04050555000839
·
Model: 1
·
Technolas Perfect Vision GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MICROKERATOME Disposable Tubing
- Primary DI
- 04050555000839
- Version / Model
- 1
- Catalog Number
- 5070063
- Company Name
- Technolas Perfect Vision GmbH
- Labeler DUNS
- 341325716
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2018-12-03
- Public Version Status
- Update
- Public Device Record Key
- 65285606-680c-4f1b-a474-acec5b418029
Device Description
Provides a connection between the microkeratome head and the vacuum (or suction) pump. The function of the tubing is to provide a conduit for suction to the eye during lamellar surgery.
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
- Yes
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32765 | Keratome, line-powered | A mains electricity (AC-powered) ophthalmic surgical instrument intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant. This device will typically have a special blade mounted to it for the cutting process. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04050555000839 | GS1 |
Customer Contacts
- Phone
- +4989940040
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 35 Degrees Celsius