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Complete Cervical Stand Alone IBD

FDA UDI

Class I (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name
Complete Cervical Stand Alone IBD FDA UDI
Generic Name
Surgical mallet FDA UDI
Device Name
Slap Hammer FDA UDI
Model / Reference
27-40-0900 FDA UDI
Description
Slap Hammer FDA UDI

Identifiers

Catalog Number
27-40-0900 FDA UDI
Primary DI / UDI-DI
10889981115975 FDA UDI
FDA Product Code
FZY FDA UDI
GMDN Term
Surgical mallet 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: Surgical mallet

Complete Cervical Stand Alone IBD by SeaSpine Orthopedics Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical mallet.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI ce814d88-1022-430c-a7f8-3aea12223eb6 35 fields · synced Jun 8, 2026