FDA UDI
In Commercial Distribution
🇺🇸 United States
Eye Shield
DI: M68906205060
·
Model: 06
·
Safeguard US Operating, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Eye Shield
- Primary DI
- M68906205060
- Version / Model
- 06
- Catalog Number
- 06-205
- Company Name
- Safeguard US Operating, LLC
- Labeler DUNS
- 118492643
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-13
- Public Version
- 2
- Public Version Date
- 2026-03-19
- Public Version Status
- Update
- Public Device Record Key
- 8c13b78f-5fe8-4461-b857-872173c3bb36
Device Description
The MARCH™ Polycarb Eye Shield is a standard ophthalmic dressing that meets current military pre-hospital guidelines for the treatment of traumatic eye injury in the field. It is a polycarbonate eye shield that is enhanced with an attached edge protecting garter. Strong and Lightweight Eye Protection.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
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 | M68906205060 | HIBCC |
Customer Contacts
- Phone
- 855-428-6074
- [email protected]