FDA UDI
In Commercial Distribution
🇺🇸 United States
EdgeDam™ Refill Medium 5x5 Latex-Free
DI: 00359883006723
·
Model: 838200-E
·
DEN-MAT HOLDINGS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EdgeDam™ Refill Medium 5x5 Latex-Free
- Primary DI
- 00359883006723
- Version / Model
- 838200-E
- Catalog Number
- EDVLFM5550
- 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
- 44077456-6f7e-4d62-a5ae-d9bc62b4b632
Device Description
Premium Polyisoprene Dental Dam
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
- Yes
- 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 |
|---|---|---|---|---|
| EIE | DAM, RUBBER | Dental | 872.6300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45004 | Rubber dam, non-latex | A sheet of elastomeric synthetic material (e.g., silicone) that is punched with holes and placed over the teeth during dental procedures. It can have a variety of functions such as: 1) to isolate the field of operation from the rest of the oral cavity; 2) to eliminate saliva; 3) to prevent the patient swallowing liquid/dental material; 4) to protect soft tissue from harmful solutions; and 5) to reduce risk of infection. This device may be used for patients and/or staff that have an allergy to latex. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00359883006723 | GS1 |
Customer Contacts
- Phone
- +1(800)433-6628
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Area/Surface Area | 25 | Square inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature
- Type
- Storage Environment Temperature
- Temperature Range
- High: 25 Degrees Celsius