FDA.report

NA

Primary DI
10886705015993
Brand
NA
Company
DEPUY MITEK, LLC
Model
281337
Catalog number
281337
Device description
Trocar for Storz / Linvatec sheath (281332)
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
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HNXDEPRESSOR, ORBITAL

Product Code Classifications

CodeDeviceSpecialtyClass
HNXDepressor, OrbitalOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10886705015993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088670501599310886705015993

GMDN Terms

TermDefinition
Orthopaedic trocar blade, reusableA rigid hand-held surgical instrument with a sharp (pyramidal or conical) point designed to be used during orthopaedic surgery for the manual puncture of a bodily entry point to: 1) gently part the surrounding soft tissue upon entry; 2) assist in the location and positioning of skeletal fractures; and/or 3) assist alignment of surgical instruments/implants. It is typically made of high-grade stainless steel, titanium (Ti), or synthetic material. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

Regulatory Flags

DUNS number
190572854
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
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 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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