FDA.report

TAG

Primary DI
03596010089953
Brand
TAG
Company
Smith & Nephew, Inc.
Model
013102
Catalog number
013102
Device description
TAG DEPTH STOP 2MM
Published
2015-08-30
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
MBIFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Product Code Classifications

CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03596010089953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03596010089953035960100899533596010089953

GMDN Terms

TermDefinition
Orthopaedic implant/instrument depth limiterAn orthopaedic device designed to limit the depth of insertion of a surgical instrument (e.g., a drill bit or a reamer), a trial implant, or an implant. It may be used as a stand-alone device or it may be attached to another device to control the insertion depth; this can be to prevent the insertion of an instrument or implant below the surgical field of interest thereby avoiding damage to tissue behind or below the target structures. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of shapes and lengths. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)821-5700gudid@smith-nephew.com
+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
true
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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