FDA.report

N/A

Primary DI
00885825011963
Brand
N/A
Company
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Model
N/A
Catalog number
298-97-101
Device description
Sternum Saw Blade
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
GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Product Code Classifications

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00885825011963PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00885825011963008858250119638858250119630885825011963

GMDN Terms

TermDefinition
Sternum saw blade, reprocessedA flat metal surgical instrument with a serrated edge intended to be attached to a dedicated powered surgical saw for cutting the sternum (the breastbone) during cardiovascular surgery. It is available in various forms (e.g., straight or arc shaped) and is powered by a rapid reciprocating or oscillating motion provided by the saw. This is a previously used single-use device that has been processed for an additional single-use patient application.

Device Sizes

TypeValueUnit
Depth32Millimeter
Device Size Text, specify0
Width6.27Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)888-3433RegulatoryAffairs2@stryker.com

Regulatory Flags

DUNS number
020198912
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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