FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00812480011236
·
Model: 5600GEN
·
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00812480011236
- Version / Model
- 5600GEN
- Catalog Number
- 5600GEN
- Company Name
- MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
- Labeler DUNS
- 790265227
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-27
- Public Version
- 2
- Public Version Date
- 2021-10-29
- Public Version Status
- Update
- Public Device Record Key
- 54bb0038-f4d3-4735-be1d-ee5a3c0bf7cc
Device Description
Cannula Insertion System, 25 Gauge, Sterile, Single Step, Generic, w/ Tubing Set
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HMX | Cannula, Ophthalmic | Ophthalmic | 886.4350 | 1 |
| NGY | Cannula, Trocar, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46840 | Ophthalmic cannulation set, single-use | A collection of non-powered devices intended to be used to create a channel into the eye for posterior segment ophthalmic surgery [e.g., infusion and/or aspiration of an ophthalmic replacement medium (e.g., silicone oil)]. It consists of metal cannulae, often with tubing, and includes additional ophthalmic instruments/devices intended to support the cannulation procedure (e.g., a trocar, plug, syringe, filter); it may be used in conjunction with a dedicated pump (not included) for pressure-controlled fluid delivery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10812480011233 | GS1 | Carton | 6 | In Commercial Distribution | |
| Primary | 00812480011236 | GS1 |
Customer Contacts
- Phone
- 1(800)929-5227
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 25 | Gauge |