Identity
- Trade Name
- New Image FDA UDI
- Generic Name
- Colostomy irrigation kit, single-use FDA UDI
- Device Name
- 2-Piece Ostomy Irrigator Sleeve FDA UDI
- Model / Reference
- 18154 FDA UDI
- Description
- 2-Piece Ostomy Irrigator Sleeve FDA UDI
Identifiers
- Catalog Number
- 18154 FDA UDI
- Primary DI / UDI-DI
- 00610075181544 FDA UDI
- FDA Product Code
- EXD FDA UDI
- GMDN Term
- Colostomy irrigation kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5895 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 70 Millimeter FDA UDI
Category: Colostomy irrigation kit, single-use
New Image by Hollister Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Colostomy irrigation kit, single-use.
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- New Image — Hollister Incorporated · Class II
- New Image — Hollister Incorporated · 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 |
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Manufacturer
- Manufacturer
- Hollister Incorporated
Sources (1)
- FDA UDI 001c8d0b-7ace-4d78-8640-64cfb49083ba 36 fields · synced Jun 9, 2026