FDA.report

V. Mueller

Primary DI
10885403096846
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
OP1500-002
Catalog number
OP1500-002
Device description
V. Mueller FOREIGN BODY SPUD DBL-END HNDL, LENGTH 4" (10.2CM) FLAT SPUD ONLY 2 X 18MM WORKING LENGTH 27MM
Published
2022-11-27
Public version status
New
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
JYTPICK, MICROSURGICAL EAR

Product Code Classifications

CodeDeviceSpecialtyClass
JYTPick, Microsurgical EarEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885403096846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088540309684610885403096846

GMDN Terms

TermDefinition
Eye spudA hand-held, manual, ophthalmic surgical instrument intended to be used to remove a foreign body/object embedded in or adhering to the surface of the eye globe. It is typically made of high-grade stainless steel, and designed with a fine handle at the proximal end and a thin concave blade with a rounded nose at the distal end. The ophthalmologist uses this tip to remove the foreign body/object. 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
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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