FDA UDI
In Commercial Distribution
🇺🇸 United States
Lachrymal Cannulae
DI: 15056030402354
·
Model: M9272-02/10
·
STERIMEDIX LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Lachrymal Cannulae
- Primary DI
- 15056030402354
- Version / Model
- M9272-02/10
- Catalog Number
- M9272
- Company Name
- STERIMEDIX LIMITED
- Labeler DUNS
- 504799313
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-10-07
- Public Version
- 1
- Public Version Date
- 2024-10-15
- Public Version Status
- New
- Public Device Record Key
- bc23465f-efce-4fcd-bd4e-8281039bce2b
Device Description
23g x 1/2" Lachrymal
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MED | Sterilant, Medical Devices | General Hospital | 880.6885 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10575 | Lacrimal procedural cannula | A hand-held, manual, rigid or semi-rigid instrument intended to be inserted into the lacrimal drainage system (the lacrimal duct) to perform various ocular irrigation or aspiration procedures (e.g., lacrimal syringing). It may also be used during placement of a lacrimal tube/stent, or in procedures for the extraction of the cortex lentis or softer parts of the lens of the eye. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 35056030402358 | GS1 | ||||
| Primary | 15056030402354 | GS1 |