FDA UDI
In Commercial Distribution
🇺🇸 United States
HOUSING CAP WITH ORING WHITE
DI: D785002CAPWORW0
·
Model: 002 CAP WITH O-RING WHITE
·
OCO BIOMEDICAL INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HOUSING CAP WITH ORING WHITE
- Primary DI
- D785002CAPWORW0
- Version / Model
- 002 CAP WITH O-RING WHITE
- Catalog Number
- 002 CAP W/O-RING (WHITE)
- Company Name
- OCO BIOMEDICAL INC
- Labeler DUNS
- 094146123
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-12
- Public Version
- 2
- Public Version Date
- 2024-04-04
- Public Version Status
- Update
- Public Device Record Key
- f8024801-10aa-45de-8027-e0b5b2a3bd0b
Device Description
002 CAP WITH O-RING (WHITE)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38625 | Denture clasp, polymer, preformed | A prefabricated dental device made of polymer material intended to retain and stabilize a removable partial denture to stationary teeth. It is manufactured to meet a standard specification for adaptation or direct insertion into the patient's mouth. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D785002CAPWORW0 | HIBCC |