FDA.report

FMS

Primary DI
20886705022073
Brand
FMS
Company
DEPUY MITEK, LLC
Model
283719
Catalog number
283719
Device description
FMS AGGRESSIVE BLADE PLUS 5.0mm
Published
2015-09-01
Public version status
Update
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

Contact Domains

Product Codes

CodeName
HRXARTHROSCOPE

Product Code Classifications

CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20886705022073PackageGS15In Commercial Distribution
10886705022076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088670502207320886705022073
1088670502207610886705022076

GMDN Terms

TermDefinition
Arthroscopic shaver system blade, single-useA powered, cutting device designed for use in an arthroscopic shaver system handpiece (not included) for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It is locked into the handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector that performs a rotational or reciprocating (back and forth) motion. It is typically made of high-grade stainless steel. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags

DUNS number
190572854
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10886705007516FASTIN ETHIBOND2221522221522015-09-01
20886705000903NA2103092103092015-09-01
10886705000951NA2104092104092015-09-01
10886705001088LUPINE ETHIBOND2107102107102015-09-01
10886705001958QUICKANCHOR PANACRYL2121312121312015-09-01
10886705001989GII QUICKANCHOR PANACRYL2121342121342015-09-01
10886705001996QUICKANCHOR PANACRYL2121352121352015-09-01
10886705002047ETHIBOND2123102123102015-09-01
20886705002051ETHIBOND2123152123152015-09-01
10886705002061GII ETHIBOND2124502124502015-09-01
10886705002184PANALOK QUICKANCHOR PANACRYL2127322127322015-09-01
10886705002191PANALOK QUICKANCHOR ORTHOCORD2127332127332015-09-01
20886705002204GII PANACRYL2127342127342015-09-01
10886705007493FASTIN ETHIBOND2221302221302015-09-01
10886705007509FASTIN ETHIBOND2221402221402015-09-01
20886705008190FASTIN ETHIBOND2225302225302015-09-01
20886705008213FASTIN ETHIBOND2225522225522015-09-01
10886705008575QUICKANCHOR ORTHOCORD2229792229792015-09-01
10886705008605ORTHOCORD2229822229822015-09-01
10886705017904BRISTOW LATARJET2852202852202015-09-01

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