FDA UDI
In Commercial Distribution
🇺🇸 United States
XS GATES
DI: 07640142421634
·
Model: 03.140.10.604.GC
·
FKG Dentaire Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- XS GATES
- Primary DI
- 07640142421634
- Version / Model
- 03.140.10.604.GC
- Catalog Number
- 03.140.10.604.GC
- Company Name
- FKG Dentaire Sàrl
- Labeler DUNS
- 482884061
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-14
- Public Version
- 1
- Public Version Date
- 2022-08-22
- Public Version Status
- New
- Public Device Record Key
- ad2a2bb3-ce6a-42a2-82ec-544b932a8c74
Device Description
Gates 140, 15 mm, # 4, ultra-short, handle GC
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- Yes
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZA | Drill, Dental, Intraoral | Dental | 872.4130 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31876 | Endodontic enlarger, reusable | A manual dental instrument designed to be used to access the root canal and to enlarge the opening of the coronal portion of the root canal. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640142421634 | GS1 |