Codman Certas®

FDA UDI

Class II (US FDA UDI)

by Integra LifeSciences Production Corporation

Identity

Trade Name: CODMAN CERTAS® FDA UDI
Generic Name: Cerebrospinal fluid shunt valve programmer FDA UDI
Device Name: CODMAN CERTAS® Replacement, Indicator for use ONLY as part of the CODMAN CERTAS TOOLKIT (REF: 82-8851) FDA UDI
Model / Reference: 828860 FDA UDI
Description: CODMAN CERTAS® Replacement, Indicator for use ONLY as part of the CODMAN CERTAS TOOLKIT (REF: 82-8851) FDA UDI

Identifiers

Catalog Number: 82-8860 FDA UDI
Primary DI / UDI-DI: 10381780521341 FDA UDI
510(k) Number: K143111 FDA UDI
FDA Product Code: JXG FDA UDI
GMDN Term: Cerebrospinal fluid shunt valve programmer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5550 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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Cerebrospinal fluid shunt valve programmer

Codman Certas® by Integra LifeSciences Production Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cerebrospinal fluid shunt valve programmer.

M.BLUE PLUS — AESCULAP, INC. · Class II
Strata II Adjustment Kit — Medtronic PS Medical · Class II
proGAV 2.0® — Christoph Miethke GmbH & Co. KG · Class II
proSA® — Christoph Miethke GmbH & Co. KG · Class II
M.BLUE PLUS — AESCULAP, INC. · Class II
Strata™ — Medtronic PS Medical · Class II
proGAV® — Christoph Miethke GmbH & Co. KG · Class II
Strata® — Medtronic PS Medical · Class II

Cleared under the same submission

K143111 also covers:

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

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

Manufacturer

Manufacturer: Integra LifeSciences Production Corporation

Sources (1)

FDA UDI a75d1578-28d5-41b2-88fa-9b4cf41c5384 36 fields · synced Jun 9, 2026