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Superior Mid-Shaft Narrow Straight Clavicle Plate Procedure Kit 8 hole, Right

FDA UDI

Class II (US FDA UDI)

by Wishbone Medical Inc.

Identity

Trade Name
Superior Mid-Shaft Narrow Straight Clavicle Plate Procedure Kit 8 hole, Right FDA UDI
Generic Name
Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial FDA UDI
Model / Reference
PK-SMC0835NSR-TI-US FDA UDI

Identifiers

Primary DI / UDI-DI
B562PKSMC0835NSRTIUS0 FDA UDI
FDA Product Code
HRS FDA UDI
GMDN Term
Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 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

Yes

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: Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

Superior Mid-Shaft Narrow Straight Clavicle Plate Procedure Kit 8 hole, Right by Wishbone Medical Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wishbone Medical Inc.

Sources (1)

  • FDA UDI e7d025a5-267e-4341-9bea-43227cc42914 32 fields · synced May 31, 2026