FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 10884389104521
·
Model: MDSK10331
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
34
Basic Information
- Brand Name
- Medline
- Primary DI
- 10884389104521
- Version / Model
- MDSK10331
- Catalog Number
- MDSK10331
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 34
- Record Status
- Published
- Publish Date
- 2023-01-21
- Public Version
- 1
- Public Version Date
- 2023-01-30
- Public Version Status
- New
- Public Device Record Key
- 089a2246-6843-48aa-85d4-e782f5050591
Device Description
SPECULA, EAR 4.25MM, 8,500 EACH
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
- Yes
- 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 |
|---|---|---|---|---|
| ERA | OTOSCOPE | Ear, Nose, Throat | 874.4770 | 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 | 20884389104528 | GS1 | BAG | 25 | In Commercial Distribution | |
| Primary | 10884389104521 | GS1 | ||||
| Package | 40884389104522 | GS1 | CASE | 250 | In Commercial Distribution | |
| Unit of Use | 80884389104520 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]