Identity
- Trade Name
- BIOSUC-C7 FDA UDI
- Generic Name
- Body aspiration needle, single-use FDA UDI
- Device Name
- 22G x 100mm with suction syringe FDA UDI
- Model / Reference
- BIO22100 FDA UDI
- Description
- 22G x 100mm with suction syringe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04526737120034 FDA UDI
- 510(k) Number
- K013108 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Body aspiration needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 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
- Needle Gauge — 22 Gauge FDA UDILength — 100 Millimeter FDA UDI
Category: Body aspiration needle, single-use
Biosuc-C7 by Hakko Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Body aspiration needle, single-use.
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- MReye — COOK INCORPORATED · Class II
Cleared under the same submission
K013108 also covers:
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
- Hakko Co., Ltd.
Sources (1)
- FDA UDI 5c1d42cd-bd41-4cca-9e43-2edcc39cdb81 36 fields · synced May 30, 2026