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Pass Lp

FDA UDI

Class II (US FDA UDI)

by Medicrea International SA

Identity

Trade Name
PASS LP FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
MIS PEDICLE SCREW Ø8.5 mm x 45 mm FDA UDI
Model / Reference
B36208545 FDA UDI
Description
MIS PEDICLE SCREW Ø8.5 mm x 45 mm FDA UDI

Identifiers

Catalog Number
B36208545 FDA UDI
Primary DI / UDI-DI
03613720285526 FDA UDI
510(k) Number
K190376 FDA UDI
FDA Product Code
NKB FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Pass Lp by Medicrea International SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K190376 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medicrea International SA

Sources (1)

  • FDA UDI a5d52271-31f9-4354-9591-b4488891157f 36 fields · synced Jun 7, 2026