FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 10304040108786
·
Model: 5701403
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 10304040108786
- Version / Model
- 5701403
- Catalog Number
- 5701403
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2019-10-28
- Public Version
- 1
- Public Version Date
- 2019-11-05
- Public Version Status
- New
- Public Device Record Key
- 3e0fbc4b-5a77-4bd4-a39a-2eb483f13f0a
Device Description
Dental syringe, 6cc Luer Lock Non sterile
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
- 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
- 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 |
|---|---|---|---|---|
| EIC | SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63683 | Anaesthesia Luer syringe, non-sterile | A non-sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer (infuse) anaesthetic drugs. At the distal end of the barrel is a male Luer connector (typically a Luer-lock type) for the attachment of the female connector (hub) of a hypodermic needle, administration set or dental syringe cannula. It is typically made of plastic and silicone materials and may have anti-stick properties (internally precoated with compatible substances) that allow the plunger to move smoothly. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20304040108783 | GS1 | case | 12 | In Commercial Distribution | |
| Primary | 10304040108786 | GS1 | ||||
| Unit of Use | 00304040108789 | GS1 |