FDA UDI
In Commercial Distribution
🇺🇸 United States
Hygenic
DI: D661H007501
·
Model: H00750
·
COLTENE/WHALEDENT INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
52
Basic Information
- Brand Name
- Hygenic
- Primary DI
- D661H007501
- Version / Model
- H00750
- Company Name
- COLTENE/WHALEDENT INC
- Labeler DUNS
- 622185718
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 52
- Record Status
- Published
- Publish Date
- 2019-02-27
- Public Version
- 1
- Public Version Date
- 2019-03-11
- Public Version Status
- New
- Public Device Record Key
- 0c87a90d-88da-45a9-8c20-6560cabf6a5f
Device Description
FlexiDam 3.91x4.12 Purple
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
- 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 |
|---|---|---|---|---|
| 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 | D661H007501 | HIBCC | ||||
| Unit of Use | D661H007500 | HIBCC |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 80 Degrees Fahrenheit