FDA UDI
In Commercial Distribution
🇺🇸 United States
ADC
DI: 00634782054465
·
Model: 5185
·
AMERICAN DIAGNOSTIC CORP
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
850
Basic Information
- Brand Name
- ADC
- Primary DI
- 00634782054465
- Version / Model
- 5185
- Catalog Number
- 5185
- Company Name
- AMERICAN DIAGNOSTIC CORP
- Labeler DUNS
- 108999095
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 850
- Record Status
- Published
- Publish Date
- 2018-07-13
- Public Version
- 2
- Public Version Date
- 2019-06-07
- Public Version Status
- Update
- Public Device Record Key
- dc423eb6-6b6e-4a91-96bf-163c04944b7c
Device Description
Specula, Disposable,4.25mm, 850/pkg
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| EPY | Speculum, Ent | General, Plastic Surgery | 878.1800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34897 | Ear speculum, single-use | A semi-rigid or rigid, plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may be referred to as an ear cannula. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00634782554255 | GS1 | MASTER | 10 | In Commercial Distribution | |
| Primary | 00634782054465 | GS1 | ||||
| Unit of Use | 00634782094515 | GS1 |
Customer Contacts
- Phone
- 1-800-232-2670
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 4.25 | Millimeter |