Identity
- Trade Name
- Orbit Inserter FDA UDI
- Generic Name
- Insulin infusion cannula introducer FDA UDI
- Device Name
- Box of one (1) Infusion Set Inserter FDA UDI
- Model / Reference
- MODD1 Insulin Delivery System FDA UDI
- Description
- Box of one (1) Infusion Set Inserter FDA UDI
Identifiers
- Catalog Number
- MTL-46 FDA UDI
- Primary DI / UDI-DI
- 00850037806058 FDA UDI
- 510(k) Number
- K163400 FDA UDI
- FDA Product Code
- KZH FDA UDI
- GMDN Term
- Insulin infusion cannula introducer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6920 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Insulin infusion cannula introducer
Orbit Inserter by Modular Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Insulin infusion cannula introducer.
- Orbit®Inserter — Ypsomed AG · Class II
- MODD1 Starter Kit — Modular Medical, Inc. · Class II
- MODD1 Patient Welcome Kit — Modular Medical, Inc. · Class II
Cleared under the same submission
K163400 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Modular Medical, Inc.
Sources (1)
- FDA UDI 1441b426-0da1-4355-86e5-cbfac4215ebc 36 fields · synced Jun 1, 2026