FDA.report

NA

Primary DI
04546540362377
Brand
NA
Company
STRYKER CORPORATION
Model
5820066216
Catalog number
5820066216
Device description
1.6mm Cross-Cut Fissure Extended
Published
2016-09-23
Public version status
Update
Distribution status
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
GFFBur, Surgical, General & Plastic Surgery
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Product Code Classifications

CodeDeviceSpecialtyClass
GFFBur, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04546540362377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04546540362377045465403623774546540362377

GMDN Terms

TermDefinition
Cranial bur, single-useA rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal and/or diamond material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate soft or hard skull tissue. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)253-3210Inst.Stryker.cs@Stryker.com

Regulatory Flags

DUNS number
196548481
Device count
1
DM exempt
false
Premarket exempt
false
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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