FDA.report

V. Mueller

Primary DI
10885403201899
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
NL3785-013T
Catalog number
NL3785-013T
Device description
RHOTON MICRO CURETTE CUP 2MM X 1MM WIDE TITANIUM. STRAIGHT. OVERALL LENGTH 7-1/2"(19.1CM)
Published
2018-08-30
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
GZXINSTRUMENT, MICROSURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
GZXInstrument, MicrosurgicalNeurology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885403201899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088540320189910885403201899

GMDN Terms

TermDefinition
Neurosurgical curette, single-useA hand-held manual surgical instrument intended to be used to scrape and debride tissue from a bone surface (e.g., cancellous vertebral bone of the spine) or a cavity wall during a neurosurgical procedure. It consists of a long, thin, metal shaft that terminates distally into a spoon-, scoop- or mushroom-like cutting head, that can be set at alternative angles, which enables a smooth scoring action for the creation of grooves or channels. It is typically used during percutaneous kyphoplasty to treat vertebral compression fractures (VCFs), or during craniotomy or brain microsurgery. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)323-9088Customer_Support@BD.com
+1(800)548-4873xx@xx.xx

Regulatory Flags

DUNS number
832696038
Device count
1
DM exempt
true
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

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50885403192829Scrub Care ExidineCLEAN1CLEAN12018-05-02
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