FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Extended Tip Applicator
DI: 10884521171367
·
Model: 205208
·
Covidien LP
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Extended Tip Applicator
- Primary DI
- 10884521171367
- Version / Model
- 205208
- Company Name
- Covidien LP
- Labeler DUNS
- 058614483
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2023-02-24
- Public Version Status
- Update
- Public Device Record Key
- cc130850-adba-4fb2-92ef-58b5426c7437
- Distribution End Date
- 2023-02-21
Device Description
Single Use Applicator
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
- 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 |
|---|---|---|---|---|
| FMF | Syringe, piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58780 | Open-surgery adhesive/sealant applicator, single-channel | A sterile applicator designed for the controlled application of a surgical adhesive/sealant during open surgery (e.g., laparotomy, vascular surgery) for various haemostatic and/or tissue bonding uses. It typically consists of an applicator (e.g., dropper, spreader) for use with a single-component syringe; it may include the syringe and additional devices to assist extraction of the adhesive/sealant from a bottle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20884521171364 | GS1 | CASE | 5 | Not in Commercial Distribution | 2023-02-21 |
| Primary | 10884521171367 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8 | Centimeter |