FDA.report

Reprocessed 2.9mm Full Radius Blade

Primary DI
B39034191
Brand
Reprocessed 2.9mm Full Radius Blade
Company
SURETEK MEDICAL
Model
3419
Published
2016-09-12
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

Product Codes

CodeName
HRXArthroscope
NBHAccessories, Arthroscopic

Product Code Classifications

CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B39034191PrimaryHIBCC0

GMDN Terms

TermDefinition
Arthroscopic shaver system blade, reprocessedA sterile, powered, rotational, cutting device designed for use in an arthroscopic shaver system handpiece for soft and bone tissue resection during arthroscopic surgery on a joint, e.g., a knee, shoulder, or ankle. It is locked into a handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector. The inner and outer tubes are typically made of high-grade stainless steel; the hub and connector may be made of stainless steel or a polymer [e.g., polyphenylsulfone (PPSU)]. This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods

Method

Regulatory Flags

DUNS number
785616934
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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