FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDICOM SAFEJET
DI: 10686864057274
·
Model: 1007074
·
AMD Medicom Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
250
Basic Information
- Brand Name
- MEDICOM SAFEJET
- Primary DI
- 10686864057274
- Version / Model
- 1007074
- Catalog Number
- 1007074
- Company Name
- AMD Medicom Inc
- Labeler DUNS
- 256880576
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- Record Status
- Published
- Publish Date
- 2021-05-13
- Public Version
- 1
- Public Version Date
- 2021-05-21
- Public Version Status
- New
- Public Device Record Key
- 8f8d7132-d806-43c2-9d21-d6da41cb2b1d
Device Description
MEDICOM SAFEJET DISPOSABLE AIR/WATER SYRINGE TIPS - White
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
- 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 |
|---|---|---|---|---|
| ECB | Unit, Syringe, Air And/Or Water | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45131 | Dental delivery system irrigation handpiece | A hand-held device that is used to regulate and direct a stream of pressurized, warmed water and/or air for the purpose of irrigating/clearing debris from the field of operation in the oral cavity during restorative or operative dental procedures. It is fitted with a long syringe-like nozzle that is activated by the user, typically through push-type controls. This device, also commonly known as a three-way or a Triplex syringe, is typically a component of a dental delivery system from which the air and water is supplied. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00686864057277 | GS1 | ||||
| Primary | 10686864057274 | GS1 | ||||
| Package | 20686864057271 | GS1 | OUTER CASE | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-514-636-6262
- [email protected]
- Phone
- 1-514-636-6262
- [email protected]