FDA.report

NA

Primary DI
10705034480060
Brand
NA
Company
DEPUY SPINE, LLC
Model
698341226
Catalog number
698341226
Device description
MODIFIED INSTRUMENT JAMSHIDI NEEDLE
Published
2016-11-11
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
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Product Code Classifications

CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10705034480060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1070503448006010705034480060

GMDN Terms

TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use 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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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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