FDA UDI
In Commercial Distribution
🇺🇸 United States
Safco absorbent points
DI: D72310250413
·
Model: 1025041
·
SAFCO DENTAL SUPPLY CO.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
200
Basic Information
- Brand Name
- Safco absorbent points
- Primary DI
- D72310250413
- Version / Model
- 1025041
- Catalog Number
- 1025041
- Company Name
- SAFCO DENTAL SUPPLY CO.
- Labeler DUNS
- 020417380
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2021-07-14
- Public Version
- 2
- Public Version Date
- 2021-08-11
- Public Version Status
- Update
- Public Device Record Key
- db19f890-62dc-4a69-b8fb-6646db3fa634
Device Description
Safco abs pts XF sterile cell 200/pk
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKN | POINT, PAPER, ENDODONTIC | Dental | 872.3830 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38777 | Endodontic paper point | A non-medicated absorbent point used in endodontic procedures that has been sterilized once in a manner approved by the manufacturer. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | D72310250410 | HIBCC | ||||
| Primary | D72310250413 | HIBCC |