FDA UDI
In Commercial Distribution
🇺🇸 United States
Darby Dental Supply, LLC
DI: 10889813001377
·
Model: D101A
·
DARBY DENTAL SUPPLY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
500
Basic Information
- Brand Name
- Darby Dental Supply, LLC
- Primary DI
- 10889813001377
- Version / Model
- D101A
- Catalog Number
- 9508272
- Company Name
- DARBY DENTAL SUPPLY, LLC
- Labeler DUNS
- 825137818
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2016-06-24
- Public Version
- 3
- Public Version Date
- 2018-11-08
- Public Version Status
- Update
- Public Device Record Key
- 1cfcdd06-f488-4f08-b221-4e4ffc49bddc
Device Description
TRAY SLEEVES 11.5" X 16"
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
- 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 |
|---|---|---|---|---|
| PEM | Dental barriers and sleeves | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47782 | Patient surgical drape, single-use, non-sterile | A non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a single-use device intended to be sterilized prior to use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20889813001374 | GS1 | 6 | In Commercial Distribution | ||
| Primary | 10889813001377 | GS1 | ||||
| Unit of Use | 00889813001370 | GS1 |
Customer Contacts
- Phone
- +1(516)688-6800 ext. 6431
- [email protected]