FDA UDI
In Commercial Distribution
🇺🇸 United States
Leukoplast®
DI: 04042809687491
·
Model: 76467-00
·
BSN medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
30
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Basic Information
- Brand Name
- Leukoplast®
- Primary DI
- 04042809687491
- Version / Model
- 76467-00
- Catalog Number
- 76467-00
- Company Name
- BSN medical GmbH
- Labeler DUNS
- 342651662
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 3
- Public Version Date
- 2026-03-19
- Public Version Status
- Update
- Public Device Record Key
- 97e417ee-1262-4f99-9041-45a15f8b08dd
Device Description
LEUKOPLAST EYE OCCLUSOR 4.7CM X 6.7CM JUNIOR TAN 30 HOSP
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HMP | PAD, EYE | General, Plastic Surgery | 878.4440 | 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 |
|---|---|---|---|---|---|---|
| Package | 04042809687477 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 04042809687491 | GS1 | ||||
| Unit of Use | 04042809687507 | GS1 |
Customer Contacts
- Phone
- +1(800)537-1063
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 4.7 | Centimeter | |
| Length | 6.7 | Centimeter |