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Ventral Wall Defect Silo Bag

FDA UDI

Class II (US FDA UDI)

by Bentec Medical OpCo, LLC.

Identity

Trade Name
Ventral Wall Defect Silo Bag FDA UDI
Generic Name
Gastroschisis silo bag FDA UDI
Model / Reference
GR74089-03 FDA UDI

Identifiers

Primary DI / UDI-DI
00684995400023 FDA UDI
510(k) Number
K840172 FDA UDI
FDA Product Code
FTL FDA UDI
GMDN Term
Gastroschisis silo bag FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 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

No

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

Yes

FDA UDI

Category: Gastroschisis silo bag

Ventral Wall Defect Silo Bag by Bentec Medical OpCo, LLC. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastroschisis silo bag.

Cleared under the same submission

K840172 also covers:

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 4c9782fc-87a5-415d-8b09-7b20c9fd8b8b 33 fields · synced Jun 8, 2026