FDA UDI
In Commercial Distribution
🇺🇸 United States
LAZIC
DI: 04250603746751
·
Model: 76.100.12
·
Peter Lazic GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- LAZIC
- Primary DI
- 04250603746751
- Version / Model
- 76.100.12
- Catalog Number
- 76.100.12
- Company Name
- Peter Lazic GmbH
- Labeler DUNS
- 327681359
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2022-07-01
- Public Version
- 1
- Public Version Date
- 2022-07-11
- Public Version Status
- New
- Public Device Record Key
- e2abf76d-44d6-4494-86d3-8243758d332c
Device Description
L-SID SUCTION IRRIGATION DEVICE WITH PVC-TUBE, 3M, PU=12 PCS. STERILE
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
- Yes
- 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 |
|---|---|---|---|---|
| GZX | Instrument, Microsurgical | Neurology | 882.4525 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60793 | Surgical irrigation/aspiration handpiece, single-use | A hand-held device designed to be connected to a separate cannula/tip for both irrigation and aspiration of a surgical site by regulating and directing a stream of pressurized fluid (e.g., sterile water) to the site and facilitating suction of debris from the site. It is activated by the operator, typically through a push-type control(s); it may include connection tubing, however other associated devices (e.g., cannula/tip, clamps, filters, spikes) are not included (i.e., it is neither a tubing set nor an irrigation/aspiration cannula). It is typically intended for an ear/nose/throat (ENT) procedure or neurosurgical use; it is not an ophthalmic device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250603746751 | GS1 | ||||
| Unit of Use | 04250603746676 | GS1 |
Customer Contacts
- Phone
- 1 844 261 3271
- [email protected]