FDA UDI
In Commercial Distribution
🇺🇸 United States
Dental Dams
DI: 10732224005642
·
Model: 19600
·
CROSSTEX INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
15
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Basic Information
- Brand Name
- Dental Dams
- Primary DI
- 10732224005642
- Version / Model
- 19600
- Company Name
- CROSSTEX INTERNATIONAL, INC.
- Labeler DUNS
- 057728685
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 15
- Record Status
- Published
- Publish Date
- 2023-12-20
- Public Version
- 3
- Public Version Date
- 2025-04-30
- Public Version Status
- Update
- Public Device Record Key
- 1238491d-f09e-40d9-91df-1683c652a2da
Device Description
Dental Dam, Non-Latex, Peppermint, 6" x 6",Medium, Light Blue
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
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | 50732224005640 | GS1 | Case | 40 | In Commercial Distribution | |
| Primary | 10732224005642 | GS1 | ||||
| Unit of Use | 00732224005645 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- "Keep dry"
- Type
- Special Storage Condition, Specify
- Special Conditions
- "Keep away from sunlight"