FDA UDI
In Commercial Distribution
🇺🇸 United States
SilTrax EPI Retraction Cord 9/1
DI: 00310866000381
·
Model: 07210
·
PASCAL COMPANY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SilTrax EPI Retraction Cord 9/1
- Primary DI
- 00310866000381
- Version / Model
- 07210
- Catalog Number
- 07210
- Company Name
- PASCAL COMPANY, INC.
- Labeler DUNS
- 009260217
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-29
- Public Version
- 1
- Public Version Date
- 2019-03-01
- Public Version Status
- New
- Public Device Record Key
- 1f2d4f7f-cd79-4040-ab5a-0a48d959e245
Device Description
Braided gingival retraction cord with epinephrine, 72 inches, size 9/1
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| MVL | Cord, Retraction | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46037 | Gingival retraction cord, medicated | A medicated, cotton string used to temporarily hold off the gingiva during abutment preparation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00310866000381 | GS1 |
Customer Contacts
- Phone
- 8004268051
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit