FDA UDI
In Commercial Distribution
🇺🇸 United States
Hayden Medical
DI: 00840319716625
·
Model: OP21-555
·
Hayden Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Hayden Medical
- Primary DI
- 00840319716625
- Version / Model
- OP21-555
- Catalog Number
- OP21-555
- Company Name
- Hayden Medical, Inc.
- Labeler DUNS
- 618214410
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-03
- Public Version
- 1
- Public Version Date
- 2022-08-11
- Public Version Status
- New
- Public Device Record Key
- 773c06c2-6045-4909-b359-6d5f340ba314
Device Description
Durette IV External Laser Shields, patients goggles with all metal attachments, regular
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IWS | Shield, eye, radiological | Radiology | 892.6500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64273 | Epiocular radiation shield, reusable | An opaque ocular covering intended to be used to shield the entire eye area of a patient or healthcare personnel from exposure to primary and scattered radiation (ionizing and/or non-ionizing) during a medical procedure [e.g., CT scan, dermatological laser treatment, phototherapy]. It is made of materials that prevent the transmission of harmful radiation to the eyes (e.g., lead, tungsten, plastic), and is typically in the form of a single or double opaque shield adhered to the face in front of the eyes (i.e. not directly on the corneal surface); it is not designed as goggles or spectacles. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840319716625 | GS1 |
Customer Contacts
- Phone
- +1(661)296-7200
- [email protected]