FDA.reportPublic FDA data

NA

Primary DI
04546540110138
Brand
NA
Company
Stryker Trauma SA
Model
700225
Catalog number
700225
Device description
Osteotom 16mm
Published
2020-09-24
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
04546540110138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540110138045465401101384546540110138

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). 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
false
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
07613327667738NASIT0006000SIT00060002025-03-28
07613327084191STEINMANN3593-1-0903593-1-0902025-01-09
07613327614633PANGEA5420045420042024-12-01
07613327624786PANGEA542110S542110S2024-12-01
07613327624809PANGEA5421125421122024-12-01
07613327624816PANGEA5421375421372024-12-01
07613327624830PANGEA5421855421852024-12-01
07613327624847PANGEA5421385421382024-12-01
07613327624861PANGEA5421185421182024-12-01
07613327624878PANGEA5421365421362024-12-01
07613327624885PANGEA5421195421192024-12-01
07613327624908PANGEA5421325421322024-12-01
07613327624915PANGEA542130S542130S2024-12-01
07613327624939PANGEA5421395421392024-12-01
07613327624977PANGEA5421725421722024-12-01
07613327624984PANGEA5421545421542024-12-01
07613327624991PANGEA5421205421202024-12-01
07613327625011PANGEA542132S542132S2024-12-01
07613327625028PANGEA5421135421132024-12-01
07613327625035PANGEA5421865421862024-12-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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