← Back to catalogue

AVID TruCustom

FDA UDI

Class II (US FDA UDI)

by Avid Medical, Inc.

Identity

Trade Name
AVID TruCustom FDA UDI
Generic Name
Birthing/delivery kit FDA UDI
Model / Reference
BUAH031-05_0004 FDA UDI

Identifiers

Catalog Number
BUAH031-05 FDA UDI
Primary DI / UDI-DI
10809160255889 FDA UDI
FDA Product Code
OKV FDA UDI
GMDN Term
Birthing/delivery kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.4520 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

Yes

FDA UDI

Combination Product

Yes

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

No

FDA UDI

Category: Birthing/delivery kit

The AVID TruCustom is a comprehensive birthing and delivery kit designed for obstetric procedures, containing sterile instruments, dressings, and pharmaceuticals necessary for the procedure. It is a single-use device, implantable: false, and labeled as a no-r NRL device.

Similar devices

Also classified as Birthing/delivery kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Avid Medical, Inc.

Sources (1)

  • FDA UDI 75e8da9d-e915-4a46-82b0-b9219208ca3c 34 fields · synced Jul 25, 2026