FDA UDI
Not in Commercial Distribution
🇺🇸 United States
GYRUS ACMI, INC
DI: 00821925019096
·
Model: 230860
·
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
- 00821925019096
- Version / Model
- 230860
- Company Name
- Gyrus ACMI, LLC
- Labeler DUNS
- 007198742
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-09
- Public Version
- 7
- Public Version Date
- 2024-09-02
- Public Version Status
- Update
- Public Device Record Key
- 64be15cf-5094-41db-8e9d-c7783d4fc7bd
- Distribution End Date
- 2017-06-22
Device Description
SUCT IRRG SHEATH
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
- 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 |
|---|---|---|---|---|
| EOB | NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) | Ear, Nose, Throat | 874.4760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35205 | Rigid optical nasopharyngoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the nasopharynx (the upper part of the throat behind the nose). It is inserted through a nostril during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00821925019096 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K932988 | 000 |