FDA UDI
In Commercial Distribution
🇺🇸 United States
Mantainer anterior chamber 23G
DI: 08052276019448
·
Model: AK-0331
·
AKTIVE SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Mantainer anterior chamber 23G
- Primary DI
- 08052276019448
- Version / Model
- AK-0331
- Catalog Number
- AK-0331
- Company Name
- AKTIVE SRL
- Labeler DUNS
- 433533053
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2024-01-08
- Public Version
- 1
- Public Version Date
- 2024-01-16
- Public Version Status
- New
- Public Device Record Key
- 7ae5683a-bd46-401e-a7b6-dd7d7ca9f617
Device Description
Mantainer anterior chamber 23G
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 |
|---|---|---|---|---|
| HMX | Cannula, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47240 | Ophthalmic irrigation/infusion/aspiration tubing, single-use | A length of flexible, noninvasive tube intended to connect an ophthalmic cannula to an external device(s) [e.g., pump, bottles] for infusion, irrigation and/or aspiration (suction) during an ophthalmic procedure [e.g., tamponade, glaucoma treatment]. It is made of polymer material(s), may incorporate single- or double-lumen and may be provided in rolls from which required lengths are cut, or in predetermined lengths. It may be provided with simple connectors; however, it does not include other associated items (e.g., clamp, spike) [i.e., not a tubing set]. 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 | 08056477555002 | GS1 | ||||
| Primary | 08052276019448 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | GAUGE |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius