FDA.report

NA

Primary DI
07611819657397
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
03.168.013
Catalog number
03168013
Device description
PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS
Published
2018-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07611819657397Direct MarkingGS10
10886982274441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07611819657397076118196573977611819657397
1088698227444110886982274441

GMDN Terms

TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags

DUNS number
832637081
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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10886982293251NA04.045.234040452342025-01-31
10886982293268NA04.045.236040452362025-01-31
10886982293275NA04.045.238040452382025-01-31
10886982293282NA04.045.240040452402025-01-31
10886982293299NA04.045.242040452422025-01-31
10886982293305NA04.045.244040452442025-01-31
10886982293312NA04.045.246040452462025-01-31
10886982293329NA04.045.248040452482025-01-31
10886982293336NA04.045.250040452502025-01-31
10886982293343NA04.045.252040452522025-01-31
10886982293350NA04.045.254040452542025-01-31
10886982293367NA04.045.256040452562025-01-31

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