FDA.report

REMOTION

Primary DI
00886385014654
Brand
REMOTION
Company
Stryker Trauma SA
Model
300-1400
Catalog number
300-1400
Device description
Wrist Instr. PGT Radial Burr, Large
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
00886385014654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385014654008863850146548863850146540886385014654

GMDN Terms

TermDefinition
Orthopaedic bur, reusableA rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a reusable device.

Sterilization Methods

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

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