FDA UDI
In Commercial Distribution
🇺🇸 United States
USA Elite
DI: 00821925028784
·
Model: REXM3-110A
·
Gyrus ACMI, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- USA Elite
- Primary DI
- 00821925028784
- Version / Model
- REXM3-110A
- Company Name
- Gyrus ACMI, LLC
- Labeler DUNS
- 007198742
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-12
- Public Version
- 2
- Public Version Date
- 2024-09-02
- Public Version Status
- Update
- Public Device Record Key
- 3b69363a-038c-40c3-89da-06942411fcfe
Device Description
USA Elite System M3 Autoclavable Retrograde Telescope 110 Degrees, Color Coded Red
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | 884.1690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37084 | Rigid endoscope telescope | An optical device designed to provide the illumination and image transmission capabilities of a rigid endoscope. It typically includes a set of lenses (e.g., thin and rod-shaped lenses) and/or a fibreoptic bunch, and is introduced though the sheath of the endoscope (e.g., a rigid cystoscope or resectoscope). The endoscopic telescope is connected proximally to a light source, and the returning image is directly observed or scanned with a video camera. Dedicated types are available for direct, lateral, and oblique views. It is used for examination of body cavities following natural tracts (e.g., urinary, gastrointestinal) or surgical cavities (e.g., laparoscopic). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00821925028784 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K890328 | 000 |