FDA UDI
Not in Commercial Distribution
🇺🇸 United States
V. Mueller
DI: 10885403014772
·
Model: BE597
·
CAREFUSION 2200, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- V. Mueller
- Primary DI
- 10885403014772
- Version / Model
- BE597
- Catalog Number
- BE597
- Company Name
- CAREFUSION 2200, INC
- Labeler DUNS
- 832696038
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-11
- Public Version
- 3
- Public Version Date
- 2022-03-04
- Public Version Status
- Update
- Public Device Record Key
- b2e30eae-55bb-4ecd-86d0-c9f6b72ef820
- Distribution End Date
- 2021-04-22
Device Description
V. Mueller LEWY TEFLON GLYCERINE MIXTURE INJECTION NEEDLE, 19GA BAYONET, LENGTH OF NEEDLE FROM HUB TO END 9-3/8" (23.8CM)
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
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMI | Needle, hypodermic, single lumen | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62529 | Vocal cord medialization implant needle | A rigid, sharp, bevel-edged, hollow, tubular metal instrument intended to be used for injection of a vocal cord medialization implant, in gel form, into the vocal cord without direct visualization. It is typically curved to enable navigation of the pharynx; it is not intended to be used with an endoscope. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10885403014772 | GS1 |
Customer Contacts
- Phone
- +1(800)323-9088
- [email protected]
- Phone
- +1(800)323-9088
- [email protected]