FDA UDI
In Commercial Distribution
🇺🇸 United States
Re-Cord™ Knitted Retraction Cord #00
DI: 00359883005702
·
Model: 649102
·
DEN-MAT HOLDINGS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Re-Cord™ Knitted Retraction Cord #00
- Primary DI
- 00359883005702
- Version / Model
- 649102
- Catalog Number
- 649102
- Company Name
- DEN-MAT HOLDINGS, LLC
- Labeler DUNS
- 809857704
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-12
- Public Version
- 1
- Public Version Date
- 2025-03-20
- Public Version Status
- New
- Public Device Record Key
- 2a176667-4bee-48dd-ae48-d05846fb0d7a
Device Description
Gingival retraction cord, non-medicated
Device Characteristics
- Single Use
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| JES | FLOSS, DENTAL | Dental | 872.6390 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46037 | Gingival retraction cord, medicated | A medicated (e.g., with epinephrine) cotton string intended to be used to temporarily push gum tissue (gingiva) away from prepared tooth margins to help make an accurate dental impression. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00359883005702 | GS1 |
Customer Contacts
- Phone
- +1(800)433-6628
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 244 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from heat, sparks and flame.
- Type
- Handling Environment Temperature
- Temperature Range
- High: 25 Degrees Celsius