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Pcm

FDA UDI

Class III (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name
PCM FDA UDI
Generic Name
Internal spinal fixation procedure kit, single-use FDA UDI
Device Name
PCM Breamer, Ø2.35 ANS Sterile (US) FDA UDI
Model / Reference
7679925P FDA UDI
Description
PCM Breamer, Ø2.35 ANS Sterile (US) FDA UDI

Identifiers

Primary DI / UDI-DI
00887517403445 FDA UDI
PMA Number
P100012 FDA UDI
FDA Product Code
MJO FDA UDI
GMDN Term
Internal spinal fixation procedure kit, 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

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: Internal spinal fixation procedure kit, single-use

Pcm by Nuvasive, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal spinal fixation procedure kit, single-use.

Cleared under the same submission

P100012 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nuvasive, Inc.

Sources (1)

  • FDA UDI 83429c57-5ec2-4254-97e3-4d7568616789 35 fields · synced Jun 6, 2026