FDA.report

Integra™

Primary DI
M269NL87002001
Brand
Integra™
Company
Integra Lifesciences Corporation
Model
NL8700200
Device description
Silicone Coated Brain Retractors are fabricated with polyester reinforced silicone elastomer, covering a malleable stainless steel core, used for tissue retraction in neurosurgical procedures.
Published
2016-06-20
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
GADRETRACTOR

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780211174PrimaryGS10
M269NL87002001SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178021117410381780211174

GMDN Terms

TermDefinition
Brain retractorA hand-held manual surgical instrument designed for the temporary atraumatic separation and/or drawing aside of the margins of a sulcus or fissure of the brain, or margin of an incision of the brain, during neurosurgical procedures. It is typically made of high-grade stainless steel and is available in a variety of shapes and sizes including flat uniform section instruments (e.g., straight, S-shaped) and also instruments with a loop handle attached to straight or curved distal blade. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags

DUNS number
083171244
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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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