FDA.report

V. Mueller

Primary DI
10885403010200
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
AU12930
Catalog number
AU12930
Device description
V. Mueller MCCABE CANAL KNIFE DIAMETER 2.5MM,SHARP,ROUND BLD ANGLD 45DEG,SQUARE HOLLOW HANDLE OVERALL LENGTH 6-1/4" (15.9CM)
Published
2018-07-13
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
KTGKNIFE, ENT

Product Code Classifications

CodeDeviceSpecialtyClass
KTGKnife, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885403010200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088540301020010885403010200

GMDN Terms

TermDefinition
Ear knifeA hand-held manual surgical instrument intended to cut and dissect tissues of the ear during a surgical intervention. It is typically designed as a one-piece instrument with a sharp, single-edged, cutting blade at the distal end; this is normally quite small and may be of various shapes, and has a long slender shaft with a handle at the proximal end. It is normally made of high-grade stainless steel. This is a reusable 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
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

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50885403142183NA442044202018-07-18
50885403142190NA4461A4461A2018-07-18
50885403142220NA4472A4472A2018-07-18
50885403175211NA443744372018-07-18
50885403184473NA446844682018-07-18
50885403184480NA4469A4469A2018-07-18
50885403192829Scrub Care ExidineCLEAN1CLEAN12018-05-02
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