FDA.report

OBTURATOR 3.2mm

Primary DI
00848665014266
Brand
OBTURATOR 3.2mm
Company
ADVANCED ORTHOPEDIC SOLUTIONS INC
Model
0625
Published
2016-02-25
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
00848665014266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848665014266008486650142668486650142660848665014266

GMDN Terms

TermDefinition
Surgical drill guide obturatorA surgical device designed to fill the lumen of a drill guide during its insertion to a surgical site primarily to prevent tissue obstruction of the drill guide lumen. When the drill guide is firmly placed at the chosen position on the bone surface, the obturator is removed. It is typically a rod with a rounded distal end, which protrudes out of the drill guide, and a knob-like handle that functions as a regulator to control the length of the protruding end and to remove it from the drill guide. It is typically made of a high-grade stainless steel. 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
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

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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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