FDA UDI
In Commercial Distribution
🇺🇸 United States
Visitec®
DI: 30886158002254
·
Model: 581019
·
Beaver-Visitec International, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Visitec®
- Primary DI
- 30886158002254
- Version / Model
- 581019
- Catalog Number
- 581019
- Company Name
- Beaver-Visitec International, Inc.
- Labeler DUNS
- 001406024
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-27
- Public Version
- 2
- Public Version Date
- 2026-03-19
- Public Version Status
- Update
- Public Device Record Key
- 5a76aac8-cedc-4f4e-981f-6c28e9498475
Device Description
SHIELD EYE LEFT/RIGHT 8.5CM (50/SP)
Device Characteristics
- Single Use
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HOY | Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) | Ophthalmic | 886.4750 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61490 | Eye patch, single-use | A device intended to be used to close/cover one or both eyes to protect the eye after a procedure and/or as part of an ophthalmic therapeutic intervention (e.g., after cataract surgery or for the treatment of amblyopia). It is made of a synthetic or biological material. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30886158002254 | GS1 |
Customer Contacts
- Phone
- +1(866)906-8080
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a dry place.