FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 20763000039893
·
Model: 1419020
·
MEDTRONIC XOMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- N/A
- Primary DI
- 20763000039893
- Version / Model
- 1419020
- Company Name
- MEDTRONIC XOMED, INC.
- Labeler DUNS
- 835465063
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-10-15
- Public Version
- 1
- Public Version Date
- 2020-10-23
- Public Version Status
- New
- Public Device Record Key
- 722663da-c0f8-48df-ba77-32dcf233459f
Device Description
COLLECTOR 1419020 10PK TYMPANOCENTESIS
Device Characteristics
- Single Use
- Yes
- 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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JZF | TUBE, EAR SUCTION | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62605 | ENT surgical aspirator | A sterile hand-held device intended to be used to aspirate fluid from a ENT cavity (e.g., middle ear) during a single surgical procedure. It typically consists of a flexible tube inserted into the cavity, a collection container and a connection to the wall outlet of a central vacuum system. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00763000039899 | GS1 | ||||
| Primary | 20763000039893 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]