12mm Distraction Pin 301.912S1

GUDID 00850014548001

12mm Distraction Pin

FOLSOM METAL PRODUCTS, INC.

Intraoperative bone pin/screw, sterile Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use
Primary Device ID00850014548001
NIH Device Record Keyb1084a41-86bb-46b2-be4a-faaefa588423
Commercial Distribution StatusIn Commercial Distribution
Brand Name12mm Distraction Pin
Version Model Number301.912S1
Catalog Number301.912S1
Company DUNS878146737
Company NameFOLSOM METAL PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850014548001 [Primary]

FDA Product Code

GCZRetainer, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-24
Device Publish Date2020-02-14

On-Brand Devices [12mm Distraction Pin]

0085001454800112mm Distraction Pin
1085001454800812mm Distraction Pin Quantity 10 DI 00850014548001

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