FDA.report

V. Mueller

Primary DI
20885403128797
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
OP07531
Catalog number
OP07531
Device description
SUPER SHARP BLADE DISP KNIFE #75-31 BLK
Published
2018-09-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EMFKNIFE, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMFKnife, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20885403128797PackageGS110Not in Commercial Distribution
10885403128790PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088540312879720885403128797
1088540312879010885403128790

GMDN Terms

TermDefinition
Scalpel blade, single-useA sterile interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use device.

Sterilization Methods

Method

Contacts

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

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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