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SeaSpine Spacer System - Pacifica

FDA UDI

Class I (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name
SeaSpine Spacer System - Pacifica FDA UDI
Generic Name
Bone file FDA UDI
Device Name
Box Cutter 11mm x 7mm FDA UDI
Model / Reference
93-3400 FDA UDI
Description
Box Cutter 11mm x 7mm FDA UDI

Identifiers

Catalog Number
93-3400 FDA UDI
Primary DI / UDI-DI
10889981088323 FDA UDI
FDA Product Code
FZT FDA UDI
GMDN Term
Bone file FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Bone file

SeaSpine Spacer System - Pacifica by SeaSpine Orthopedics Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone file.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SeaSpine Orthopedics Corporation

Sources (1)

  • FDA UDI 8a47ad11-2d34-41e2-be42-c62b5d3ad2fc 36 fields · synced Jun 8, 2026