Identity
- Trade Name
- Heating tube set for insufflation, reusable FDA UDI
- Generic Name
- Laparoscopic insufflator FDA UDI
- Model / Reference
- Z1415-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056702000080 FDA UDI
- 510(k) Number
- K001533 FDA UDI
- FDA Product Code
- HIF FDA UDI
- GMDN Term
- Laparoscopic insufflator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1730 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Laparoscopic insufflator
Heating tube set for insufflation, reusable by W.O.M. World of Medicine GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laparoscopic insufflator.
- Insufflator — Guangdong Optomedic Technologies, Inc. · Class II
- COMEG MEDICAL — SOPRO · Class II
- COMEG MEDICAL — SOPRO · Class II
- COMEG MEDICAL — SOPRO · Class II
- COMEG MEDICAL — SOPRO · Class II
- HIGHFLOW — Richard Wolf GmbH · Class II
- COMEG MEDICAL — SOPRO · Class II
- COMEG MEDICAL — SOPRO · 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
- W.O.M. World of Medicine GmbH
Sources (1)
- FDA UDI 89721c21-5352-4840-8264-a8a4314df294 33 fields · synced May 30, 2026