FDA.report

Humeral Nail Instrument Tray

Primary DI
00848665024203
Brand
Humeral Nail Instrument Tray
Company
ADVANCED ORTHOPEDIC SOLUTIONS INC
Model
9921
Published
2018-05-01
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

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848665024203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848665024203008486650242038486650242030848665024203

GMDN Terms

TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
117858154
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
true
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

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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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