FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 10304040165154
·
Model: 5703105
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
144
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 10304040165154
- Version / Model
- 5703105
- Catalog Number
- 5703105
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 144
- Record Status
- Published
- Publish Date
- 2023-07-31
- Public Version
- 1
- Public Version Date
- 2023-08-08
- Public Version Status
- New
- Public Device Record Key
- 8d81856e-ea2e-44d2-9e99-253531644939
Device Description
Henry Schein Lubricating Jelly 3g Packet
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KMJ | Lubricant, patient | General Hospital | 880.6375 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60796 | General-body orifice lubricant | A substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00304040165157 | GS1 | ||||
| Primary | 10304040165154 | GS1 |