FDA.reportPublic FDA data

MEDLINE UNITE

Primary DI
10888277690967
Brand
MEDLINE UNITE
Company
MEDLINE INDUSTRIES, INC.
Model
MPN41006
Catalog number
MPN41006
Device description
DEPTH GAUGE, AO STYLE, 40MM
Published
2020-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXWBENDER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXWBenderOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888277690967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088827769096710888277690967

GMDN Terms#

Term, Definition table
TermDefinition
Growth-correction orthopaedic fixation plate kitA collection of implantable devices used to redirect the angle of growth of long bones in paediatric patients where the growth plates (epiphysial cartilage) are not fused, to allow for the gradual correction of congenital or acquired deformities (e.g., valgus, varus, or flexion deformities of the knee, ankle, or elbow). It typically includes various-sized sheets of surgical steel or titanium alloy, and bone screws to attach the sheets to the bone surface over the growth plates. The screws may be allowed to swivel in their position so that the implant acts like a hinge, permitting growth at the growth plate to gradually straighten the limb.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118144928LEVEL ONE EXTREMITYKLS-Martin L.P.HXW2026-05-25
03662663108386Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCHXW2026-02-11
00840536800237Response Spine SystemORTHOPEDIATRICS CORP.HXW2026-01-15
00840180543283General InstrumentsALPHATEC SPINE, INC.HXW2025-12-31
00840180543290General InstrumentsALPHATEC SPINE, INC.HXW2025-12-31
10889981095987GeneralSeaspine Orthopedics CorporationHXW2025-12-19
03662663261869BacFix Ti Spinal Fixation SystemHighridge Medical, LLCHXW2025-12-18
00840194418140PediflexORTHOPEDIATRICS CORP.HXW2025-12-11
00840493413907RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00840493413914RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00840493413921RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00840493413938RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00840493413945RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00199150044375Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXW2025-11-24
00199150044382Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXW2025-11-24
03662663153379Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663153386Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663153393Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663153409Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663191784Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663214872Vital Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663214889Vital Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663214896Vital Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663146227Gallery Laminoplasty Fixation SystemHighridge Medical, LLCHXW2025-11-15
03662663113410Virage OCT Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-14
03662663131995Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-14
03662663132008Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-14
03662663136785Polaris 4.75 Deformity SystemHighridge Medical, LLCHXW2025-11-14
03662663136792Polaris 4.75 Deformity SystemHighridge Medical, LLCHXW2025-11-14
03662663136808Polaris 4.75 Deformity SystemHighridge Medical, LLCHXW2025-11-14