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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
CMHM011-06_0003 FDA UDI

Identifiers

Primary DI / UDI-DI
10809160065396 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

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

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Birthing/delivery kit

The AVID TruCustom obstetrical kit is a comprehensive medical device designed for the birthing and delivery of newborns. This single-use, sterilized instrument set includes necessary dressings, pharmaceuticals, and sterile devices required for this procedure. With a public version number of 2, it is widely used in hospitals and clinics worldwide.

Similar devices

Also classified as Birthing/delivery kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Avid Medical, Inc.

Sources (1)

  • FDA UDI 515dadca-a312-43a5-8871-df0dc110530a 32 fields · synced Jul 7, 2026