FDA UDI
In Commercial Distribution
🇺🇸 United States
ScleralTrack Needle
DI: 00813465010145
·
Model: 1525
·
HURRICANE MEDICAL INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- ScleralTrack Needle
- Primary DI
- 00813465010145
- Version / Model
- 1525
- Catalog Number
- 1525
- Company Name
- HURRICANE MEDICAL INC
- Labeler DUNS
- 093377724
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-01-21
- Public Version
- 2
- Public Version Date
- 2020-04-07
- Public Version Status
- Update
- Public Device Record Key
- 61863f11-7def-4294-a1a4-1b937c987e2e
Device Description
For administrating local anesthetics prior to ophthalmic surgery.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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", "Radiation Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAA | Needle, Aspiration And Injection, Disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59230 | Hypodermic needle, single-use | A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00813465010145 | GS1 | ||||
| Unit of Use | 10813465010142 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 16 | Millimeter | |
| Needle Gauge | 25 | Gauge |