Identity
- Trade Name
- INFILTRATION TUBING FDA UDI
- Generic Name
- Surgical irrigation/aspiration tubing set FDA UDI
- Device Name
- 15' LARGE BORE TUBING W/SILICONE INSERT FOR INFILTRATION PUMP SYSTEMS -SINGLE SPIKE, BOX OF 10 FDA UDI
- Model / Reference
- B89216 FDA UDI
- Description
- 15' LARGE BORE TUBING W/SILICONE INSERT FOR INFILTRATION PUMP SYSTEMS -SINGLE SPIKE, BOX OF 10 FDA UDI
Identifiers
- Catalog Number
- B89216 FDA UDI
- Primary DI / UDI-DI
- B089B892161 FDA UDI
- FDA Product Code
- GAZ FDA UDI
- GMDN Term
- Surgical irrigation/aspiration tubing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical irrigation/aspiration tubing set
Infiltration Tubing by Black & Black Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Medline — MEDLINE INDUSTRIES, 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 |
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Manufacturer
- Manufacturer
- Black & Black Surgical, Inc.
Sources (1)
- FDA UDI 60561ced-3802-4d1a-949f-6ec0b4a80fae 35 fields · synced May 30, 2026