FDA UDI
In Commercial Distribution
🇺🇸 United States
SARASOTA MEMORIAL
DI: 00840216106963
·
Model: SARASOTA01
·
Asp Global, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SARASOTA MEMORIAL
- Primary DI
- 00840216106963
- Version / Model
- SARASOTA01
- Company Name
- Asp Global, LLC
- Labeler DUNS
- 080361159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-26
- Public Version
- 1
- Public Version Date
- 2022-09-05
- Public Version Status
- New
- Public Device Record Key
- e70b5040-68d7-4dfa-89bc-1d4b60faffd8
Device Description
AMENITY KIT, SARASOTA MEM WELCOME, BLUE BAG WITH WHITE LOGO TO INCLUDE 1 DENTAL PACK, 1 FACIAL TISSUE PACK 10CT, 1 PATIENT BEDSIDE PAPER BAG, 1 HAND SANITIZER W/ ALCOHOL, 1 PAIR BLUE EAR PLUGS, AND 1
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| EFW | Toothbrush, Manual | Dental | 872.6855 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31817 | Basic manual toothbrush | An instrument designed to be used by a patient to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device is typically used with toothpaste. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840216106963 | GS1 |