Identity
- Trade Name
- FANSLER OPERATING SPECULUM FDA UDI
- Generic Name
- Rectal speculum FDA UDI
- Device Name
- FANSLER OPERATING SPECULUM SLOTTED TUBEEXTRA LONG HANDLE FDA UDI
- Model / Reference
- 508-338C FDA UDI
- Description
- FANSLER OPERATING SPECULUM SLOTTED TUBEEXTRA LONG HANDLE FDA UDI
Identifiers
- Catalog Number
- 508-338C FDA UDI
- Primary DI / UDI-DI
- 00192896044494 FDA UDI
- FDA Product Code
- FFQ FDA UDI
- GMDN Term
- Rectal speculum FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4730 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rectal speculum
Fansler Operating Speculum by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rectal speculum.
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Sklar® — Sklar Corporation · Class I
- PILLING — TELEFLEX INCORPORATED · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- ELMED — ELMED INCORPORATED · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI c384ce70-1b33-4d79-ad2b-af3f07aadba1 36 fields · synced May 31, 2026