INSTRUMENT

Primary DI
07613327012132
Brand
INSTRUMENT
Company
Howmedica Osteonics Corp.
Model
2107-4000
Catalog number
2107-4000
Device description
RESTORATION ANATOMIC SHELL - DRILL GUIDE
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
KWLProsthesis, hip, hemi-, femoral, metal
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MAYProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
MBLProsthesis, hip, semi-constrained, uncemented, metal/polymer, porous
MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic FinishOrthopedic2
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327012132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327012132076133270121327613327012132

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
058311945
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

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Primary DIBrandModelCatalogPublished
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04546540167446EXETER0942-2-1160942-2-1162015-09-24
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07613327648416Instrument5533-T-810-R5533-T-810-R2026-02-26
07613327648423Instrument5533-T-816-L5533-T-816-L2026-02-26
07613327648430Instrument5533-T-809-L5533-T-809-L2026-02-26
07613327648447Instrument5533-T-814-R5533-T-814-R2026-02-26
07613327648454Instrument5533-T-809-R5533-T-809-R2026-02-26
07613327648461Instrument5533-T-810-L5533-T-810-L2026-02-26
07613327648478Instrument5533-T-811-R5533-T-811-R2026-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07611996074901SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074901SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996074901SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074918SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074918SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074918SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074925SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074925SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074925SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996074932SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074932SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996074932SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074949SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074949SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074949SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996074956SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996074956SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074956SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074963SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074963SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074963SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074970SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074970SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074970SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996074987SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074987SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074987SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996074994SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074994SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074994SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19