FDA UDI
In Commercial Distribution
🇺🇸 United States
Irrigating Cystotome Formed 27G x 16mm
DI: 08052276012937
·
Model: 5008
·
AKTIVE SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- Irrigating Cystotome Formed 27G x 16mm
- Primary DI
- 08052276012937
- Version / Model
- 5008
- Catalog Number
- 5008
- Company Name
- AKTIVE SRL
- Labeler DUNS
- 433533053
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2023-12-19
- Public Version
- 1
- Public Version Date
- 2023-12-27
- Public Version Status
- New
- Public Device Record Key
- abf16a21-8909-47af-a766-706a4dcbc6e3
Device Description
Irrigating Cystotome Formed 27G x 16mm
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
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HNY | Cystotome | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47007 | Ophthalmic surgical irrigation/infusion/aspiration handle, single-use | A hand-held, manual tubular device designed as an interface between an ophthalmic cannula intended for infusion, irrigation and/or aspiration (e.g., a capsular polishing or a cystotome cannula) and associated tubing, to facilitate manipulation of the cannula. It is typically made of metal or a durable polymer and is in the form a cylinder, that has a Luer fitting at the distal end, for connection to the cannula. It is typically used in cataract surgery. 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 | 08056477557129 | GS1 | ||||
| Primary | 08052276012937 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | GAUGE |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius