FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 00304040101032
·
Model: 9004742
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
120
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 00304040101032
- Version / Model
- 9004742
- Catalog Number
- 9004742
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 120
- Record Status
- Published
- Publish Date
- 2019-10-14
- Public Version
- 1
- Public Version Date
- 2019-10-22
- Public Version Status
- New
- Public Device Record Key
- 00955f22-7ee4-4462-8ac6-02ada07f5749
Device Description
Maxima Absorb Pts CC#501
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00304040101032 | GS1 | ||||
| Unit of Use | 10304040100926 | GS1 |