Identity
- Trade Name
- Graves Speculum FDA UDI
- Generic Name
- Vaginal speculum, single-use FDA UDI
- Device Name
- Intended Use: Graves Vaginal Speculum is a gynecological instrument used for performing pelvic examinations, Pap Smears, and examining the cervix Packaging: Packaging: Packaging shall be as per customer requirements e.g set of 25 or set of 50. FDA UDI
- Model / Reference
- SU-21-0040-03 FDA UDI
- Description
- Intended Use: Graves Vaginal Speculum is a gynecological instrument used for performing pelvic examinations, Pap Smears, and examining the cervix Packaging: Packaging: Packaging shall be as per customer requirements e.g set of 25 or set of 50. FDA UDI
Identifiers
- Catalog Number
- SU-21-0040-03 FDA UDI
- Primary DI / UDI-DI
- G165SU210040030 FDA UDI
- FDA Product Code
- HDF FDA UDI
- GMDN Term
- Vaginal speculum, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.4520 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Vaginal speculum, single-use
Graves Speculum by Elmed Instruments(pvt)ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Elmed Instruments(pvt)ltd.
Sources (1)
- FDA UDI bc19a8f4-dd5f-4497-9349-bb8c5d3a5813 34 fields · synced May 31, 2026