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14mm Distraction Pin-Double

FDA UDI

Class I (US FDA UDI)

by Folsom Metal Products, Inc.

Identity

Trade Name
14mm Distraction Pin-Double FDA UDI
Generic Name
Intraoperative orthopaedic bone pin/screw, single-use FDA UDI
Device Name
14mm Distraction Pin-Double Quantity 10 DI 00850014548049 FDA UDI
Model / Reference
301.914S2 FDA UDI
Description
14mm Distraction Pin-Double Quantity 10 DI 00850014548049 FDA UDI

Identifiers

Catalog Number
301.914S2 FDA UDI
Primary DI / UDI-DI
10850014548046 FDA UDI
FDA Product Code
GCZ FDA UDI
GMDN Term
Intraoperative orthopaedic bone pin/screw, single-use 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intraoperative orthopaedic bone pin/screw, single-use

14mm Distraction Pin-Double by Folsom Metal Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intraoperative orthopaedic bone pin/screw, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Folsom Metal Products, Inc.

Sources (1)

  • FDA UDI 1638894a-de78-4068-9d3b-f765cf693c48 34 fields · synced Jun 8, 2026