FDA.report

NA

Primary DI
10888551007641
Brand
NA
Company
STERILMED, INC.
Model
BRAKM71-552
Catalog number
KM71-552
Device description
SAW BLADE OSCILLATING LARGE BONE
Published
2018-06-18
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

Contact Domains

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
10888551007641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088855100764110888551007641

GMDN Terms

TermDefinition
Oscillating surgical saw blade, reprocessedA sterile, flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge and designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery. This device is designed with cutting teeth arranged in an arc or on a flat plane at its distal end; the teeth are at a 90° angle to its shaft. It cuts when it is moved in a rapid oscillating motion. This device enables side-cutting action to be performed within a restricted-access area. This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
+1(888)541-0078customerservice@sterilmed.com
+1(888)541-0078sterilmedcs@its.jnj.com

Regulatory Flags

DUNS number
175899459
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
true

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