FDA UDI
In Commercial Distribution
🇺🇸 United States
Minne Ties Agile MMF
DI: 00850043178019
·
Model: MT-1001
·
Invisian Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Minne Ties Agile MMF
- Primary DI
- 00850043178019
- Version / Model
- MT-1001
- Catalog Number
- MT-1001
- Company Name
- Invisian Medical, LLC
- Labeler DUNS
- 117404743
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-01
- Public Version
- 1
- Public Version Date
- 2022-07-11
- Public Version Status
- New
- Public Device Record Key
- 2b67d1e5-2cd4-41a4-9a14-2d87399b0d13
Device Description
Minne Ties Sterile Large Two Pack: Two Large Sutures of the Same Size (1.0 mm/18 ga)
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
- Yes
- 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 |
|---|---|---|---|---|
| DYX | Lock, Wire, And Ligature, Intraoral | Dental | 872.4600 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48148 | Temporary maxillomandibular fixation set | A collection of sterile devices designed to provide temporary maxillomandibular fixation and immobilization. It consists of flexible plastic bands which are wrapped around teeth to form the anchorage points, and interlocking elastic chains attached to the anchorage points like laces on a hiking boot. It is used for the short term fixation of minimally displaced fractures and/or splintage of post jaw dislocation in the maxillofacial area. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850043178019 | GS1 | ||||
| Previous | 00860000906012 | GS1 |
Customer Contacts
- Phone
- 9132281857
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162046 | 000 |