FDA UDI
In Commercial Distribution
🇺🇸 United States
IMPULSION
DI: 03663394170871
·
Model: 87M
·
ETABLISSEMENTS ANTHOGYR
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- IMPULSION
- Primary DI
- 03663394170871
- Version / Model
- 87M
- Company Name
- ETABLISSEMENTS ANTHOGYR
- Labeler DUNS
- 275978864
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-13
- Public Version
- 1
- Public Version Date
- 2025-02-21
- Public Version Status
- New
- Public Device Record Key
- 63fe2218-1137-48e9-b62e-e38727e48999
Device Description
KEY
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
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EFA | Handpiece, belt and/or gear driven, dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47866 | Orthopaedic implant/instrument dismantling device | A device designed to dismantle (take apart) the component parts of an implant or a surgical instrument that have previously been assembled. It may be used as a stand-alone device or in combination with another device to control the dismantling process of, e.g., complex implants (e.g., a modular vertebral implant that has to be dismantled if the combination of the component parts do not fit the required size) or instruments so that these are correctly disassembled, without causing damage to any of the parts. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of shapes and lengths. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03663394170871 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K093894 | 000 |