FDA UDI
In Commercial Distribution
🇺🇸 United States
POLARISATION FILTER P2 ML 4
DI: 04053755181155
·
Model: 000
·
Heine Optotechnik GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- POLARISATION FILTER P2 ML 4
- Primary DI
- 04053755181155
- Version / Model
- 000
- Catalog Number
- J-000.31.322
- Company Name
- Heine Optotechnik GmbH & Co. KG
- Labeler DUNS
- 315274563
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-15
- Public Version
- 1
- Public Version Date
- 2022-12-23
- Public Version Status
- New
- Public Device Record Key
- 2ea8b93d-e153-4cf5-9a27-f78859a27665
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
- 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 |
|---|---|---|---|---|
| HPP | Headlamp, Operating, Battery-Operated | Ophthalmic | 886.4335 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46807 | Head-worn lamp | An electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04053755181155 | GS1 |
Customer Contacts
- Phone
- +1 (603) 742-7103
- [email protected]