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Sterile NS System

FDA UDI

Class II (US FDA UDI)

by Jeil Medical Corporation

Identity

Trade Name
Sterile NS System FDA UDI
Generic Name
Cranioplasty plate, alterable FDA UDI
Model / Reference
SN16-ST-006 FDA UDI

Identifiers

Primary DI / UDI-DI
08806390855150 FDA UDI
510(k) Number
K170368 FDA UDI
FDA Product Code
GWO FDA UDI
GXR FDA UDI
HBW FDA UDI
GMDN Term
Cranioplasty plate, alterable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5320 FDA UDI
882.5250 FDA UDI
882.5360 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

Yes

FDA UDI

Category: Cranioplasty plate, alterable

Sterile NS System by Jeil Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cranioplasty plate, alterable.

Cleared under the same submission

K170368 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Jeil Medical Corporation

Sources (1)

  • FDA UDI 9ac0aea1-3057-4304-96da-2aa7395624a5 33 fields · synced May 30, 2026