FDA.report

REMOTION

Primary DI
00886385014661
Brand
REMOTION
Company
Stryker Trauma SA
Model
300-1500
Catalog number
300-1500
Device description
Wrist Instr. PGT Radial Burr Collar
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HTTBURR, ORTHOPEDIC
JWJPROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED

Product Code Classifications

CodeDeviceSpecialtyClass
HTTBurr, OrthopedicOrthopedic1
JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-ConstrainedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00886385014661PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385014661008863850146618863850146610886385014661

GMDN Terms

TermDefinition
Orthopaedic implant aiming/guiding block, reusableA surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. This is a reusable device.

Sterilization Methods

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

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