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Single Use Silc Cup with tubing (Obstetrics)
FDA UDIClass II (US FDA UDI)
by Medela LLC
Identity
- Trade Name
- Single Use Silc Cup with tubing (Obstetrics) FDA UDI
- Generic Name
- Foetal vacuum extraction system cup, single-use FDA UDI
- Device Name
- Single Use Silc Cup with tubing (Obstetrics) The Single Use Silc Cup is intended to assist a clinician in the vacuum delivery of an infant during childbirth. The device is single use. FDA UDI
- Model / Reference
- 077.0791 FDA UDI
- Description
- Single Use Silc Cup with tubing (Obstetrics) The Single Use Silc Cup is intended to assist a clinician in the vacuum delivery of an infant during childbirth. The device is single use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07612367009355 FDA UDI
- FDA Product Code
- BTA FDA UDIHDB FDA UDI
- GMDN Term
- Foetal vacuum extraction system cup, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 FDA UDI884.4340 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
Yes
FDA UDI
Category: Foetal vacuum extraction system cup, single-use
Single Use Silc Cup with tubing (Obstetrics) by Medela LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Foetal vacuum extraction system cup, single-use.
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- ATMOS S 351 NATAL – basic set, 230 V (Medi-Vac®) — ATMOS MedizinTechnik GmbH & Co. KG · Class IIa
- ATMOS S 351 NATAL, 230 V — ATMOS MedizinTechnik GmbH & Co. KG · Class IIa
- Mityvac® — CooperSurgical, Inc. · Class IIa
- Silicone Birth Vac Cup — FORTUNE MEDICAL INSTRUMENT CORP. · Class IIa
Cleared under the same submission
K130123 also covers:
- Angle piece — Medela LLC
- Angle piece — Medela LLC
- Angle piece yellow DCS — Medela LLC
- Basic — Medela LLC
- Basic — Medela LLC
- Basic portable — Medela LLC
- Basic rack — Medela LLC
- Change-over valve with clampholder and tubing set — Medela LLC
- Clamp holder, plastic — Medela LLC
- Diposable virus / odour Filter — Medela LLC
- Disposable Overflow Protection / Bacteria Odour Filter — Medela LLC
- Disposable Overflow Protection / Bacteria filter — Medela LLC
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
- Medela LLC
Sources (1)
- FDA UDI e3df1593-519d-4edf-b252-33683949b12d 35 fields · synced Jun 8, 2026