Identity
- Trade Name
- MONARCH DISPOSO-SPEC FDA UDI
- Generic Name
- Vaginal speculum, single-use FDA UDI
- Device Name
- ONE TIME USE (LARGE) WHITE PLASTIC DISPOSABLE VAGINAL SPECULUM 100/EACH PER CASE- 4/BAGS OF 25 EACH FDA UDI
- Model / Reference
- 300W FDA UDI
- Description
- ONE TIME USE (LARGE) WHITE PLASTIC DISPOSABLE VAGINAL SPECULUM 100/EACH PER CASE- 4/BAGS OF 25 EACH FDA UDI
Identifiers
- Catalog Number
- 300WA FDA UDI
- Primary DI / UDI-DI
- 00613970003003 FDA UDI
- FDA Product Code
- HIB FDA UDI
- GMDN Term
- Vaginal speculum, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vaginal speculum, single-use
Monarch Disposo-Spec by Monarch Molding, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vaginal speculum, single-use.
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Sklar® — Sklar Corporation · Class I
- Sklar® — Sklar Corporation · Class I
- AMSure® Disposable Vaginal Speculum — AMSINO INTERNATIONAL, INC. · Class II
- Centurion — Centurion Medical Products · Class II
- Vaginal Speculum — Dynarex Corp. · Class II
- Sklar — Sklar Corporation · Class I
- Welch Allyn, Inc. — Welch Allyn, 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
- Monarch Molding, Inc.
Sources (1)
- FDA UDI e9f3121b-1b51-4e37-96d0-d30ae565ab4a 35 fields · synced Jun 8, 2026