FDA.report

V. Mueller

Primary DI
10885403105135
Brand
V. Mueller
Company
STERIS CORPORATION
Model
OS5000
Catalog number
OS5000
Device description
CRAIG VERTEBRAL BODY BIOPSY ST INCLUDES 2 NEEDLES, 2 TROCARS CANN, 2 TOOTHED CUTTERS, RACK SOCKET WRENCH,STYLET,WORM
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
OJGNeurological tray

Product Code Classifications

CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885403105135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088540310513510885403105135

GMDN Terms

TermDefinition
Vertebral bone biopsy procedure kit, reusableA collection of devices, equipment, and supplies used to obtain a bone specimen from the vertebrae of a patient (the bony segments of the spinal column) for histological analysis. It typically contains a metal cannula which can have various tip designs (e.g., bevelled, pyramidal, scoop-, or diamond-shaped) and stylet(s), a biopsy needle, an obturator, a needle holder, syringes, and connecting tube. The specimen can be used for the detection of cancer, infection, or other bone disorders. The device may also be used for vertebral infusion (e.g., injection of bone cement). This is a reusable device intended to be sterilized prior to use.

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
021599373
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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