FDA.reportPublic FDA data

12mm Distraction Pin

Primary DI
00850014548001
Brand
12mm Distraction Pin
Company
FOLSOM METAL PRODUCTS, INC.
Model
301.912S1
Catalog number
301.912S1
Device description
12mm Distraction Pin
Published
2020-02-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCZRetainer, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCZRetainer, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850014548001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014548001008500145480018500145480010850014548001

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative bone pin/screw, sterileA small sterile rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) to bone during an orthopaedic surgical procedure; it is not left in situ after the procedure. It may be wholly- or partially-threaded for screwing into bone, and may have other physical features to enable fixation of surgical instruments. It is made of metallic (e.g., stainless steel) or polymer (radiolucent) material and is available in various shapes and sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
878146737
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0085001454807012mm Distraction Pin-Double301.912S2301.912S22020-03-18
1085001454800812mm Distraction Pin 301.912301.9122020-03-18
1085001454807712mm Distraction Pin-Double301.91S2301.912S22020-03-18
0085001454804914mm Distraction Pin-Double301.914S2301.914S22020-02-18
1085001454803914mm Distraction Pin301.914S12020-02-18
1085001454804614mm Distraction Pin-Double301.914S2301.914S22020-02-18
0085001454803214mm Distraction Pin301.914S1301.914S12020-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843511123086Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123093Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123109Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123116Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123123Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123130Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123147Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
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00613244000042Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
00613244000066Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
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90841823104321Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104338Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
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00816101010363Cross Element Guide RetainerTOBY ORTHOPAEDICSGCZ2020-08-28
00816101010370Cross Element Guide SleeveTOBY ORTHOPAEDICSGCZ2020-08-28