FDA.report

NA

Primary DI
10705034479262
Brand
NA
Company
DEPUY SPINE, LLC
Model
698341662
Catalog number
698341662
Device description
MODIFIED INSTRUMENT SUCTION COBB
Published
2016-09-14
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
GCXAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10705034479262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1070503447926210705034479262

GMDN Terms

TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. 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
107105876
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
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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10705034579139N/A6983451326983451322026-03-20
10705034579146N/A6983451336983451332026-03-20
10705034579153N/A6983451346983451342026-03-20
10705034579160N/A6983451356983451352026-03-20
10705034189727OCELOT2734009002734009002016-12-31
10705034190945ALIF2735141092735141092016-12-31
10705034192178MOSS2745121002745121002016-12-31
10705034205090KEYSTONE2821804012821804012016-12-31
10705034312286NA6982028036982028032016-11-11
10705034312309NA6982028366982028362016-11-11
10705034316581NA6983276166983276162016-11-11
10705034321400NA6983291776983291772017-02-28
10705034333663NA6983334916983334912017-04-18
10705034371115NA6983353326983353322016-11-11
10705034374543SPOTLIGHT6983366506983366502017-05-18
10705034457123NA6983393746983393742016-11-11
10705034458205NA6983393236983393232016-11-11
10705034459714NA6983389206983389202016-09-14
10705034462677NA6983403376983403372016-11-11
10705034477787NA6983414746983414742016-11-11

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