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Biotronik

FDA UDI

Class III (US FDA UDI)

by BIOTRONIK SE & Co. KG

Identity

Trade Name
BIOTRONIK FDA UDI
Generic Name
Neurosurgical procedure kit, non-medicated, single-use FDA UDI
Model / Reference
SCS Resilience Acc FDA UDI

Identifiers

Catalog Number
457860 FDA UDI
Primary DI / UDI-DI
04035479170257 FDA UDI
PMA Number
P210037 FDA UDI
FDA Product Code
LGW FDA UDI
GMDN Term
Neurosurgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class III 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Neurosurgical procedure kit, non-medicated, single-use

Biotronik by BIOTRONIK SE & Co. KG — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neurosurgical procedure kit, non-medicated, single-use.

Cleared under the same submission

P210037 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
BIOTRONIK SE & Co. KG

Sources (1)

  • FDA UDI 8d340010-0f39-4bb6-807d-9262daaf94aa 36 fields · synced Jun 8, 2026