FDA UDI
In Commercial Distribution
🇺🇸 United States
Wedjets
DI: D661H080401
·
Model: H08040
·
COLTENE/WHALEDENT INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
42
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Basic Information
- Brand Name
- Wedjets
- Primary DI
- D661H080401
- Version / Model
- H08040
- Company Name
- COLTENE/WHALEDENT INC
- Labeler DUNS
- 622185718
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 42
- Record Status
- Published
- Publish Date
- 2019-02-11
- Public Version
- 1
- Public Version Date
- 2019-03-11
- Public Version Status
- New
- Public Device Record Key
- 090542b9-59b2-417f-8dc4-e4a21d95bc2e
Device Description
Wedjet Extra Small
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 11155 | Rubber dam, Hevea-latex | A sheet of elastomeric material made of Hevea natural rubber latex (NRL) 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 is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D661H080401 | HIBCC | ||||
| Unit of Use | D661H080400 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K900844 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 32 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 32 Degrees Celsius