Identity
- Trade Name
- Insufflation Needle FDA UDI
- Generic Name
- Spring-loaded pneumoperitoneum needle, single-use FDA UDI
- Device Name
- Insufflation needle to establish pneumoperitoneum. FDA UDI
- Model / Reference
- C2201 FDA UDI
- Description
- Insufflation needle to establish pneumoperitoneum. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00607915116767 FDA UDI
- FDA Product Code
- HET FDA UDI
- GMDN Term
- Spring-loaded pneumoperitoneum needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1720 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
- Length — 120 Millimeter FDA UDI
Category: Spring-loaded pneumoperitoneum needle, single-use
Insufflation Needle by Applied Medical Resources Corp. — 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
- WECK — TELEFLEX INCORPORATED · Class II
- Disposable insufflation-needle — Pajunk GmbH Medizintechnologie · Class II
- Russell PneumoFix (US) — SAFEGUARD MEDICAL TECHNOLOGIES LIMITED · Class I
- AESCULAP — AESCULAP, INC. · 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
- Applied Medical Resources Corp.
Sources (1)
- FDA UDI 1c4b2086-d71a-4eca-8c8a-8029c66d3294 35 fields · synced May 31, 2026