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Axiom®

FDA UDI

Class II (US FDA UDI)

by Axiom Medical, Incorporated

Identity

Trade Name
Axiom® FDA UDI
Generic Name
Surgical capillary wound drain, luminal, synthetic polymer FDA UDI
Device Name
Penrose Tubing, Silicone, With Holes FDA UDI
Model / Reference
101850H FDA UDI
Description
Penrose Tubing, Silicone, With Holes FDA UDI

Identifiers

Primary DI / UDI-DI
M665101850H0 FDA UDI
510(k) Number
K781749 FDA UDI
FDA Product Code
KDH FDA UDI
GMDN Term
Surgical capillary wound drain, luminal, synthetic polymer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5980 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
Lumen/Inner Diameter — 0.5 Inch FDA UDI
Length — 18 Inch FDA UDI

Category: Surgical capillary wound drain, luminal, synthetic polymer

Axiom® by Axiom Medical, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical capillary wound drain, luminal, synthetic polymer.

Cleared under the same submission

K781749 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Axiom Medical, Incorporated

Sources (1)

  • FDA UDI 84de03a2-874d-4d5d-b3db-3eda0fa75f97 36 fields · synced May 30, 2026