FDA.report

NA

Primary DI
10885862090331
Brand
NA
Company
Exactech, Inc.
Model
400-40-12
Catalog number
400-40-12
Device description
FLEX OSTEOTOME-ROUND, NA
Published
2022-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KDGCHISEL (OSTEOTOME)

Product Code Classifications

CodeDeviceSpecialtyClass
KDGChisel (Osteotome)General, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885862090331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088586209033110885862090331

GMDN Terms

TermDefinition
Orthopaedic cement extractor, electricA hand-operated, electrically-powered surgical instrument designed to extract orthopaedic (bone) cement from a site of previous application, typically during the procedure to replace a previously cemented prosthesis. This GMDN code may include slide hammers, chisels, or other power operated devices which are intended to be used to break up the bone cement for removal. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
157565946
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10885862648167Equinoxe313-07-07313-07-072026-03-19
10885862648174Equinoxe313-07-10313-07-102026-03-19
10885862648259Equinoxe313-25-38313-25-382026-03-19
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10885862648280Equinoxe313-25-47313-25-472026-03-19

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