FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 00304040115305
·
Model: 9006047
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 00304040115305
- Version / Model
- 9006047
- Catalog Number
- 9006047
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-06
- Public Version
- 1
- Public Version Date
- 2020-01-14
- Public Version Status
- New
- Public Device Record Key
- cea1ca4e-66f3-442e-889f-262df841194b
Device Description
Cotton Roll dispenser
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- Yes
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| IKX | AID, TRANSFER | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64506 | Dressing dispenser | A freestanding container with an opening designed to hold and dispense dressings (including swabs and bandages) in discrete quantities (e.g., one at a time) at the point of use. It is typically a plastic or metal container with a lid to allow loading of the dressings, and a separate port to allow easy retrieval of the dressings. It is used in settings such as an examination room, a doctor's surgery, or where surgical procedures are performed in the hospital. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00304040115305 | GS1 |