Budde®

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name: Budde® FDA UDI
Generic Name: Neurosurgical retraction system, brain FDA UDI
Device Name: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the operative site for the purposes of retracting delicate brain tissue during neurosurgical procedures. The BUDDE® Systems consist of an adjustable halo ring that rigidly attaches to a MAYFIELD® Skull Clamp or surgical table, flexible retractor arms, and various retractor blades and patty trays FDA UDI
Model / Reference: A1040P FDA UDI
Description: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the operative site for the purposes of retracting delicate brain tissue during neurosurgical procedures. The BUDDE® Systems consist of an adjustable halo ring that rigidly attaches to a MAYFIELD® Skull Clamp or surgical table, flexible retractor arms, and various retractor blades and patty trays FDA UDI

Identifiers

Primary DI / UDI-DI: 10381780253433 FDA UDI
510(k) Number: K830332 FDA UDI
FDA Product Code: GZT FDA UDI
GMDN Term: Neurosurgical retraction system, brain FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Neurosurgical retraction system, brain

Budde® by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neurosurgical retraction system, brain.

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Spatula — MIZUHO CORPORATION · Class I
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SELF-RETAINING RETRACTOR — MIZUHO CORPORATION · Class II
SELF-RETAINING RETRACTOR — MIZUHO CORPORATION · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Integra Lifesciences Corp.

Sources (1)

FDA UDI 97976de7-5651-43e2-af57-d76c03984192 36 fields · synced May 31, 2026