FDA.report

N/A

Primary DI
00613994296320
Brand
N/A
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
7480601
Device description
BODY REAMER 7480601 LARGE
Published
2017-12-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00613994296320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994296320006139942963206139942963200613994296320

GMDN Terms

TermDefinition
Orthopaedic instrument cleaning toolA hand-held manual device designed to clean the residual tissue or debris that remains embedded on or in an orthopaedic surgical instrument (e.g., reamers, bone taps) following use. The device can be in the form of wire or a strip of metal. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
830350380
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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