FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 10304040131364
·
Model: 5701933
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
225
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 10304040131364
- Version / Model
- 5701933
- Catalog Number
- 5701933
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 225
- Record Status
- Published
- Publish Date
- 2020-03-12
- Public Version
- 1
- Public Version Date
- 2020-03-20
- Public Version Status
- New
- Public Device Record Key
- e20f6a7b-9d59-4b52-b761-03018d9da1ea
Device Description
Chair Cover
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NRU | CHAIR, DENTAL, WITHOUT OPERATIVE UNIT | Dental | 872.6250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35880 | Examination/treatment table paper | A non-sterile sheet made of paper intended to cover the surface of an examination/treatment table, or chair, during use to function as a barrier between the table top and the patient to maintain hygienic conditions. It is typically supplied in a roll designed to be mounted at one end of the table such that a new length of paper can be pulled down over the table top for each new patient. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20304040131361 | GS1 | case | 4 | In Commercial Distribution | |
| Primary | 10304040131364 | GS1 | ||||
| Package | 30304040131368 | GS1 | pallet | 30 | In Commercial Distribution | |
| Unit of Use | 00304040131367 | GS1 |