FDA.reportPublic FDA data

Drill Sleeve for Calibrating Pin, φ5.0

Primary DI
06902139111937
Brand
Drill Sleeve for Calibrating Pin, φ5.0
Company
Double Medical Technology Inc.
Model
110355600
Catalog number
110355600
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131609000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131609000DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEMXiamen Double Engine Medical Material Co., Ltd.2014-05-21HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06902139111937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06902139111937069021391119376902139111937

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+865926087101info@double-medical.com

Regulatory Flags#

DUNS number
529366055
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06942782416232Universal End Cap for PFN/UFN/UTN0700800000700800002016-09-01
06942782448479End Cap for Universal Tibial Nail II0712800000712800002016-09-01
06942782448486End Cap for Universal Tibial Nail II0712800050712800052016-09-01
06942782448493End Cap for Universal Tibial Nail II0712800100712800102016-09-01
06942782448509End Cap for Universal Tibial Nail II0712800150712800152016-09-01
06902139001320Clavicular Hook Locking Plate I0200410090200410092016-09-01
06902139001337Clavicular Hook Locking Plate I0200410100200410102016-09-01
06902139001344Clavicular Hook Locking Plate I0200410110200410112016-09-01
06902139001351Clavicular Hook Locking Plate I0200420090200420092016-09-01
06902139001368Clavicular Hook Locking Plate I0200420100200420102016-09-01
06902139001375Clavicular Hook Locking Plate I0200420110200420112016-09-01
06902139001382Distal Lateral Tibial Locking Plate0201910140201910142016-09-01
06902139001399Distal Lateral Tibial Locking Plate0201910160201910162016-09-01
06902139001405Distal Lateral Tibial Locking Plate0201920140201920142016-09-01
06902139001412Narrow Limited Contact Locking Plate, Combi-holes0204100170204100172016-09-01
06902139001429Ulnar Hook Locking Plate I0213400070213400072016-09-01
06902139001436Distal Medial Tibial Locking Plate III0214910030214910032016-09-01
06902139001443Distal Medial Tibial Locking Plate III0214910040214910042016-09-01
06902139001450Distal Medial Tibial Locking Plate III0214910050214910052016-09-01
06902139001467Distal Medial Tibial Locking Plate III0214910070214910072016-09-01

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