FDA.report

SURETAC

Primary DI
03596010090669
Brand
SURETAC
Company
Smith & Nephew, Inc.
Model
013447
Catalog number
013447
Device description
GLENOID GUIDE
Published
2016-08-27
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
JDRStaple, fixation, bone

Product Code Classifications

CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03596010090669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03596010090669035960100906693596010090669

GMDN Terms

TermDefinition
Orthopaedic implant aiming armA surgical jig-like device designed as a precision guide for the pre-drilling of orthopaedic screw holes into bone and for guiding an orthopaedic instrument into an implanted device, typically to treat long bones (e.g., femur, humerus, and tibia). It typically consists of two parts in one-piece or modular configurations: 1) an insertion guide in which the correctly angled/placed guide holes are situated; and 2) an insertion handle which will attach to the bone or implant. Drill guides or other drilling/tapping devices will be fed through the insertion guide at the precise intended angle, and it may have adaptations for providing magnetic alignment. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags

DUNS number
109903521
Device count
1
DM exempt
false
Premarket exempt
false
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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