FDA.report

V. Mueller

Primary DI
10885403105104
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
OS4835
Catalog number
OS4835
Device description
V. Mueller FARABEUF-LAMBOTTE BONE HOLDING FORCEPS ADJUSTABLE OVERALL LENGTH 10" (25.4CM)
Published
2018-09-10
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
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885403105104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088540310510410885403105104

GMDN Terms

TermDefinition
Bone holding forcepsA manual surgical instrument designed to grasp and hold a bone during an open surgical procedure. It is typically strongly constructed with a scissors-like design, which may or may not be self-retaining, and with ring handles or curved shank handles. It is made of high-grade stainless steel and is available in various sizes. The working end can have a wide variety of jaws designs, e.g., curved serrated jaws, straight toothed jaws, or profiled wrench-like jaws with grooves to provide extra grip of the bone. 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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