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Solum Flow

FDA UDI

Class II (US FDA UDI)

by Celling Biosciences

Identity

Trade Name
Solum Flow FDA UDI
Generic Name
Synthetic bone graft FDA UDI
Device Name
DO NOT USE - INCORRECT PRIMARY DI NUMBER SUBMITTED IN ERROR - See 00817771028818 FDA UDI
Model / Reference
Solum Flow - 5cc FDA UDI
Description
DO NOT USE - INCORRECT PRIMARY DI NUMBER SUBMITTED IN ERROR - See 00817771028818 FDA UDI

Identifiers

Catalog Number
XXXX FDA UDI
Primary DI / UDI-DI
00817371020632 FDA UDI
510(k) Number
K132470 FDA UDI
FDA Product Code
MQV FDA UDI
GMDN Term
Synthetic bone graft FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3045 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Solum Flow by Celling Biosciences — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K132470 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Celling Biosciences

Sources (1)

  • FDA UDI 467e772a-2c6e-4f76-9bbb-a03d411971cf 36 fields · synced May 30, 2026