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Silicone Tubing, Bulk

FDA UDI

Class I (US FDA UDI)

by Bentec Medical OpCo, LLC.

Identity

Trade Name
Silicone Tubing, Bulk FDA UDI
Generic Name
Surgical capillary wound drain, luminal, synthetic polymer FDA UDI
Device Name
0.058" ID x 0.077" OD x 50 ft FDA UDI
Model / Reference
BM3-2350 FDA UDI
Description
0.058" ID x 0.077" OD x 50 ft FDA UDI

Identifiers

Primary DI / UDI-DI
00684995550063 FDA UDI
FDA Product Code
GBX FDA UDI
GMDN Term
Surgical capillary wound drain, luminal, synthetic polymer FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4200 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

Yes

FDA UDI

Category: Surgical capillary wound drain, luminal, synthetic polymer

Silicone Tubing, Bulk by Bentec Medical OpCo, LLC. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bentec Medical OpCo, LLC.

Sources (1)

  • FDA UDI 31e5d84a-d025-438b-b133-e70b7cfc9846 33 fields · synced May 31, 2026