FDA UDI
In Commercial Distribution
🇺🇸 United States
GYRUS ACMI, INC
DI: 00821925011847
·
Model: 130109
·
Gyrus ACMI, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- GYRUS ACMI, INC
- Primary DI
- 00821925011847
- Version / Model
- 130109
- Company Name
- Gyrus ACMI, LLC
- Labeler DUNS
- 007198742
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-07
- Public Version
- 3
- Public Version Date
- 2024-09-02
- Public Version Status
- Update
- Public Device Record Key
- b23ec473-11a3-43d9-bd4d-710a3d41fd04
Device Description
HOUGH PICK LARGE CURVE 12.7 MM TIP LENGTH STAINLESS STEEL EBONY FINISH
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
- No
- 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 |
|---|---|---|---|---|
| LRC | INSTRUMENT, ENT MANUAL SURGICAL | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33432 | ENT mobilizer | A hand-held, manual, stainless steel surgical instrument with a small diameter shaft tapering from the handle typically intended to be used to remobilize the footplate of the stapes to relieve conductive hearing impairment due to otosclerosis or middle ear disease. The distal tip of the shaft is bent at a slight angle to the shaft and expands to form a small platform that is larger than the distal shaft. The distal surface of the platform is shaped into a set of small ridges or projections which can be of several geometric shapes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00821925011847 | GS1 |