FDA.report

V. Mueller

Primary DI
10885403140822
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
Z-0162G
Catalog number
Z-0162G
Device description
SHADOW-LINE OFFSET LUMBAR RETRACTOR SYSTEM WITH GENESIS CONTAINER
Published
2016-09-23
Public version status
Update
Distribution status
Not 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
10885403140822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088540314082210885403140822

GMDN Terms

TermDefinition
Surgical retraction system, reusableA frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com

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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