Identity
- Trade Name
- INSUFFLATION NEEDLE,15CM FDA UDI
- Generic Name
- Spring-loaded pneumoperitoneum needle, single-use FDA UDI
- Device Name
- INSUFFLATION NEEDLE,15CM,RANFAC IN-15 PN 68017-02M FDA UDI
- Model / Reference
- 14 Gauge x 15 cm FDA UDI
- Description
- INSUFFLATION NEEDLE,15CM,RANFAC IN-15 PN 68017-02M FDA UDI
Identifiers
- Catalog Number
- IN-15 FDA UDI
- Primary DI / UDI-DI
- 00858690006990 FDA UDI
- 510(k) Number
- K930474 FDA UDI
- FDA Product Code
- FHO FDA UDI
- GMDN Term
- Spring-loaded pneumoperitoneum needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 14 Gauge FDA UDILength — 15 Centimeter FDA UDI
Category: Spring-loaded pneumoperitoneum needle, single-use
Insufflation Needle, 15cm by Ranfac Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K930474 also covers:
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 |
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Manufacturer
- Manufacturer
- Ranfac Corp.
Sources (1)
- FDA UDI f0986b9a-2b8f-4c2f-8766-3fd81fd9f622 37 fields · synced May 29, 2026