FDA.report

ORTHOLOC™ 2

Primary DI
00889797076869
Brand
ORTHOLOC™ 2
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
9914PK01
Published
2020-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HWMOSTEOTOME

Product Code Classifications

CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889797076869PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889797076869008897970768698897970768690889797076869

GMDN Terms

TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)238-7117customerservice@wmt.com

Regulatory Flags

DUNS number
807201207
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00889797024136INVISION600124002016-09-17
00889797024143INVISION600124012016-09-17
00889797040686NA49411XL2016-09-17
00889797040693NA49412XL2016-09-17
00889797040709NA49413XL2016-09-17
00889797057295EZ FRAMEEF0037002015-10-24
00889797058452EZ FRAME SIDEKICKEF0016002016-09-17
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00889797103084NAEF003005EF0030052022-06-23
00889797103107NAEF003700EF0037002022-06-23
00889797023368INVISION600022012016-09-17
00889797023375INVISION600023002016-09-17
00889797023382INVISION600023012016-09-17
00889797023436INVISION600025002016-09-17
00889797023337INVISION600021002016-09-17
00889797023344INVISION600021012016-09-17
00889797023351INVISION600022002016-09-17
00889797107679Made-To-OrderSMS00456SMS004562022-12-08
00889797108188Made-To-OrderSMS00494SMS004942022-12-08

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