FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AIRVANCE®
DI: 00763000089757
·
Model: 76353200M
·
MEDTRONIC XOMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AIRVANCE®
- Primary DI
- 00763000089757
- Version / Model
- 76353200M
- Company Name
- MEDTRONIC XOMED, INC.
- Labeler DUNS
- 835465063
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-13
- Public Version
- 3
- Public Version Date
- 2025-04-29
- Public Version Status
- Update
- Public Device Record Key
- 59252ba9-37b5-45d3-af9c-49247c711193
- Distribution End Date
- 2020-08-10
Device Description
BONE SCREW 76353200M AIRVANCE SYSTEM
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LRK | Device, anti-snoring | Dental | 872.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61483 | Sleep apnoea tongue implant, non-bioabsorbable | A sterile device intended to be implanted into the tongue to help increase airway patency by anterior advancement and physical stabilization of the tongue in the management of obstructive sleep apnoea (OSA). It is in the form of a non-bioabsorbable looped thread implanted in the base of the tongue, attached anteriorly to the mandible with a bone anchor. Disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000089757 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122391 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 60 Degrees Celsius