Identity
- Trade Name
- AESCULAP FDA UDI
- Generic Name
- Spring-loaded pneumoperitoneum needle, single-use FDA UDI
- Device Name
- INSUFFL.NEEDLE D:2.1/120MM STERILE FDA UDI
- Model / Reference
- EJ995 FDA UDI
- Description
- INSUFFL.NEEDLE D:2.1/120MM STERILE FDA UDI
Identifiers
- Catalog Number
- EJ995 FDA UDI
- Primary DI / UDI-DI
- 04046955813353 FDA UDI
- FDA Product Code
- HIF FDA UDI
- GMDN Term
- Spring-loaded pneumoperitoneum needle, single-use 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
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
Category: Spring-loaded pneumoperitoneum needle, single-use
Aesculap by Aesculap, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spring-loaded pneumoperitoneum needle, single-use.
- INSUFFLATION NEEDLE, 12CM — RANFAC CORP. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- PMI — PROGRESSIVE MEDICAL, INC. · Class II
- WECK — TELEFLEX INCORPORATED · Class II
- KIT KE201 COLE — APPLIED MEDICAL RESOURCES CORP. · Class II
- SPECIALTY SC LAP CHOLE KIT — APPLIED MEDICAL RESOURCES CORP. · Class II
- DR. SULLIVAN'S KIT — APPLIED MEDICAL RESOURCES CORP. · Class II
- DR. BEHR'S LAP CHOLE — APPLIED MEDICAL RESOURCES CORP. · 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
- Aesculap, Inc.
Sources (1)
- FDA UDI c9255dcc-ea5c-440e-95d3-958584681adf 35 fields · synced May 29, 2026