FDA UDI
In Commercial Distribution
🇺🇸 United States
American Eagle Instruments
DI: 00841013116537
·
Model: NYU4
·
AMERICAN EAGLE INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- American Eagle Instruments
- Primary DI
- 00841013116537
- Version / Model
- NYU4
- Company Name
- AMERICAN EAGLE INSTRUMENTS, INC.
- Labeler DUNS
- 790776850
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-06
- Public Version
- 1
- Public Version Date
- 2024-11-14
- Public Version Status
- New
- Public Device Record Key
- bca4b07b-7b60-4f12-9da4-6734c2502d28
Device Description
NYU 4 HATCHET (10-83-7-15)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| EMQ | HOE, PERIODONTIC | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31908 | Periodontal hoe | A hand-held manual dental instrument with a small blade at an acute angle (e.g., 90 degrees) to its stem intended to be used with a pulling action to remove gross amounts of supragingival calculus, and some subgingival calculus, in large wide-open pockets where the gingival tissue is soft and easily cleaned. It is usually made of high-grade stainless steel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841013116537 | GS1 |