Identity
- Trade Name
- Digisert FDA UDI
- Generic Name
- Rectal medication applicator, reusable FDA UDI
- Device Name
- DIGI-SERT FDA UDI
- Model / Reference
- 30500 FDA UDI
- Description
- DIGI-SERT FDA UDI
Identifiers
- Catalog Number
- 30500 FDA UDI
- Primary DI / UDI-DI
- 00840252951404 FDA UDI
- FDA Product Code
- ILS FDA UDI
- GMDN Term
- Rectal medication applicator, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5050 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Rectal medication applicator, reusable
Digisert by Therafin Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rectal medication applicator, reusable.
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- DoseRite — SURGIN SURGICAL INSTRUMENTATION, INC. · Class I
- DoseRite — SURGIN SURGICAL INSTRUMENTATION, INC. · Class I
- DoseRite — SURGIN SURGICAL INSTRUMENTATION, INC. · Class I
- DoseRite — SURGIN SURGICAL INSTRUMENTATION, INC. · Class I
- Digisert — Therafin Corporation · Class I
- Digisert — Therafin Corporation · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Therafin Corporation
Sources (1)
- FDA UDI fb594527-9957-4ca6-bd07-051ae8ff7ed3 35 fields · synced Jun 8, 2026