FDA.reportPublic FDA data

NA

Primary DI
37613154639534
Brand
NA
Company
Stryker Trauma SA
Model
52-01204
Catalog number
52-01204
Device description
Screw Marker 12/4
Published
2018-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613154639534PackageGS12In Commercial Distribution
07613154639533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761315463953437613154639534
07613154639533076131546395337613154639533

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327072631NA3901823901822021-10-27
37613327364102ENDOTRIG1052-61052-62020-09-24
37613327072670VARIAX7038187038182016-09-22
33700586902351AUTOFIX451-0031451-00312015-09-24
33700586903464AUTOFIX451-1136451-11362015-09-24
37613327356503ENDOTRIG106010602018-09-24
37613327362214EDINTRAK406040602017-05-30
37613327072403HOFFMANN4922-1-0024922-1-0022016-09-24
37613327072427HOFFMANN4922-1-0034922-1-0032016-09-24
37613327072687HOFFMANN4922-1-0064922-1-0062016-09-24
37613327072694HOFFMANN4922-1-0074922-1-0072016-09-24
37613154639497NA52-0080452-008042018-09-24
37613154639503NA52-0090452-009042018-09-24
37613154639510NA52-0100452-010042018-09-24
37613154639527NA52-0110552-011052018-09-24
37613154639541NA52-0120552-012052018-09-24
37613154639558NA52-0130452-013042018-09-24
37613154639565NA52-0130652-013062018-09-24
37613154639572NA52-0140452-014042018-09-24
37613154639589NA52-0140652-014062018-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00888867550407Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550414Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550421Arthrex®ARTHREX, INC.LXH2026-10-23
04251631412144BEE PLIFNGMedical GmbHLXH2026-10-23
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M73998301511010mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511111mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511212mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739983101200Coupling - Square ConnectCAPTIVA SPINE, INC.LXH2026-10-23
M739983240300Impaction T-HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739985202530Marking PinCAPTIVA SPINE, INC.LXH2026-10-23