FDA UDI
In Commercial Distribution
🇺🇸 United States
GYRUS ACMI
DI: 00821925039674
·
Model: 70145757
·
Gyrus Acmi, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- GYRUS ACMI
- Primary DI
- 00821925039674
- Version / Model
- 70145757
- Company Name
- Gyrus Acmi, Inc.
- Labeler DUNS
- 007198742
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 5
- Public Version Date
- 2023-08-17
- Public Version Status
- Update
- Public Device Record Key
- 23217f43-7b38-4cbd-9d73-9d0e62c1a629
Device Description
PAPARELLA "2000" #1 TWIN PACK 60 1.14MM ID ULTRASIL SOFT SILICONE
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ETD | Tube, Tympanostomy | Ear, Nose, Throat | 874.3880 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33794 | Tympanostomy tube | A small, hollow cylinder intended to be implanted, by insertion through the tympanic membrane, for ventilation or drainage of the middle ear. Otherwise known as a myringotomy tube, grommet or an aural vent tube, it is made of materials such as polytetrafluoroethylene (PTFE), polyethylene (PE), silicon elastomer, or porous polyethylene. One type, known as the malleus clip tube, attaches to the malleus. Disposable devices associated with implantation may be included with the device, which may be used to implant bilateral tubes. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00821925039674 | GS1 | ||||
| Unit of Use | 00821925040809 | GS1 | ||||
| Package | 00821925024793 | GS1 | 60 | In Commercial Distribution |
Customer Contacts
- Phone
- 18002623540
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K932166 | 000 |