Identity
- Trade Name
- VariLock FDA UDI
- Generic Name
- Catheter/overtube balloon inflator, single-use FDA UDI
- Device Name
- VariLock Balloon Inflation Syringe 3mL, Bulk Sterile FDA UDI
- Model / Reference
- VL-1001 FDA UDI
- Description
- VariLock Balloon Inflation Syringe 3mL, Bulk Sterile FDA UDI
Identifiers
- Catalog Number
- 04178 FDA UDI
- Primary DI / UDI-DI
- 00859500005127 FDA UDI
- FDA Product Code
- PTM FDA UDI
- GMDN Term
- Catheter/overtube balloon inflator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1650 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Catheter/overtube balloon inflator, single-use
VariLock by Femasys Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Catheter/overtube balloon inflator, single-use.
- basixCOMPAK™ — Merit Medical Systems, Inc. · Class II
- Monarch® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
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
- Femasys Inc.
Sources (1)
- FDA UDI f8ce0200-2050-4b2a-a0f9-337b0d5c75c1 34 fields · synced May 30, 2026