Identity
- Trade Name
- Minne Ties Agile MMF FDA UDI
- Generic Name
- Temporary maxillomandibular fixation set FDA UDI
- Device Name
- Minne Ties Sterile Standard Two Pack: Two Standard Sutures of the Same Size (1.0 mm/18 ga) FDA UDI
- Model / Reference
- MT-1001 FDA UDI
- Description
- Minne Ties Sterile Standard Two Pack: Two Standard Sutures of the Same Size (1.0 mm/18 ga) FDA UDI
Identifiers
- Catalog Number
- MT-1001 FDA UDI
- Primary DI / UDI-DI
- 00850043178019 FDA UDI
- 510(k) Number
- K162046 FDA UDI
- FDA Product Code
- DYX FDA UDI
- GMDN Term
- Temporary maxillomandibular fixation set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4600 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Temporary maxillomandibular fixation set
Minne Ties Agile MMF by Invisian Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Temporary maxillomandibular fixation set.
- MINNE TIES — Summit Medical, LLC · Class II
- MINNE TIES MT-1000 — KEYSTONE MANUFACTURING · Class II
- MINNE TIES MT-1002 — KEYSTONE MANUFACTURING · Class II
- MINNE TIES — Summit Medical, LLC · Class II
- MINNE TIES — Summit Medical, LLC · Class II
- MINNE TIES MT-1001 — KEYSTONE MANUFACTURING · Class II
- Minne Ties Agile MMF — INVISIAN MEDICAL LLC · Class II
- Minne Ties Agile MMF — INVISIAN MEDICAL LLC · Class II
Cleared under the same submission
K162046 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Invisian Medical Llc
Sources (1)
- FDA UDI 2b67d1e5-2cd4-41a4-9a14-2d87399b0d13 36 fields · synced Jun 1, 2026