FDA UDI
In Commercial Distribution
🇺🇸 United States
ARISTA AH FlexiTip XL-R
DI: 00801741096808
·
Model: AM0010
·
Davol Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ARISTA AH FlexiTip XL-R
- Primary DI
- 00801741096808
- Version / Model
- AM0010
- Catalog Number
- AM0010
- Company Name
- Davol Inc.
- Labeler DUNS
- 001191048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-01-25
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 9b5d672b-bae9-4e59-88df-8128dc0c7a20
Device Description
ARISTA AH FlexiTip XL-R 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 |
|---|---|---|---|---|
| LMG | Agent, absorbable hemostatic, non-collagen based | General, Plastic Surgery | 878.4490 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60502 | Atomizing surgical topical solution applicator | A sterile, hand-held manual surgical device intended to be used to apply a topical solution (e.g., medication) in the form of a mist/spray onto the mucosal or serosal surface of an exposed surgical site [e.g., during ear/nose/throat (ENT) or laparoscopic surgery]. It consists of a syringe connected to a cannula (e.g., via a Luer-lock), and contains a built-in atomizer. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741096805 | GS1 | CA | 10 | In Commercial Distribution | |
| Primary | 00801741096808 | GS1 |
Customer Contacts
- Phone
- +1(800)562-0027
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P050038 | 023 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 38 | Centimeter |