FDA.report

Reprocessed 3mm Straight Shaver Blade

Primary DI
B39062901120331
Brand
Reprocessed 3mm Straight Shaver Blade
Company
SURETEK MEDICAL
Model
6290-112-033
Published
2025-12-09
Public version status
New
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
GFABlade, Saw, General & Plastic Surgery, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B39062901120331PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical saw blade, sagittal, reprocessedA flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at the distal end to cut in a rapid sagittal (side to side) motion; it may in addition cut in an oscillating motion. 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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