FDA.report

AOS ES™ TROCHANTERIC NAIL, RIGHT 12.5mm x 33cm x 125°

Primary DI
00848665023398
Brand
AOS ES™ TROCHANTERIC NAIL, RIGHT 12.5mm x 33cm x 125°
Company
ADVANCED ORTHOPEDIC SOLUTIONS INC
Model
1121-335
Published
2015-10-26
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
true

Related Records

Product Codes

CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848665023398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848665023398008486650233988486650233980848665023398

GMDN Terms

TermDefinition
Femur nail, non-sterileA non-sterile rod made of metal or other material which, when inserted into the intramedullary canal of the femur, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model, and possess components to assist fixation of more proximal or distal conditions. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
117858154
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
true

Other Devices From This Company

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00848665027679COUNTERSINK4006-0002020-06-15
00848665000658AOS Drill, AO Style, 2.9mm x 100mm02242020-05-20
00848665001235AOS CANCELLOUS TAP 3.5mm02552020-05-21
00848665027624SUPRAPATELLAR TIBIAL ENTRY SHEATH06422020-05-20
00848665028041T10 Screwdriver, Short50252020-05-20
008486650280963.5mm Calibrated Drill40252020-05-20
00848665028119AOS 2.6mm Solid Reamer40212020-05-20
00848665028782T10 Screwdriver, Solid50202020-05-20
00848665028850AOS SMALL BONE REAMER Ø3.1 x 328mm4020-0312020-05-20
00848665028867AOS SMALL BONE REAMER Ø3.7 x 328mm4020-0372020-05-20
00848665028874AOS SMALL BONE REAMER Ø4.1 x 328mm4020-0412020-05-21
00848665028881AOS SMALL BONE REAMER Ø5.1 x 328mm4020-0512020-05-20
00848665028935Calibrated Drill, AO Style, 2.5mm x 200mm40162020-05-20
00848665028942Calibrated Drill, AO Style, 2.0mm x 200mm40172020-05-20
008486650292152.7mm Calibrated Drill40262020-05-20
008486650300374.0mm CORTICAL TAP (AO STYLE)40292020-05-21
00848665030051AOS T10 SCREWDRIVER, AO STYLE5008-1002020-05-21
00848665030075AOS Cannulated Drill, 2.75mm, Ankle Plate4010-1002020-05-20
00848665030099AOS DRILL, Ø2.8mm4009-1002020-05-20
00848665030105QUICK DRILL, Ø1.9mm40282020-05-20

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