FDA UDI
In Commercial Distribution
🇺🇸 United States
OCCLU-SPOT OCCLUSION SPRAY (75ml)GREEN, NON-TOXIC, CFC-FREE
DI: D2485542050
·
Model: 554205
·
HAGER WORLDWIDE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OCCLU-SPOT OCCLUSION SPRAY (75ml)GREEN, NON-TOXIC, CFC-FREE
- Primary DI
- D2485542050
- Version / Model
- 554205
- Company Name
- HAGER WORLDWIDE, INC.
- Labeler DUNS
- 009277971
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-16
- Public Version
- 1
- Public Version Date
- 2023-08-24
- Public Version Status
- New
- Public Device Record Key
- 682ca6b5-a7ec-488a-a5da-01f9b1381286
Device Description
Occlusion Spray
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| EKF | INSTRUMENT, CONTOURING, MATRIX, OPERATIVE | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16181 | Dental articulation paper | A strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D2485542050 | HIBCC |
Customer Contacts
- Phone
- +1(828)624-3319
- [email protected]