FDA.reportPublic FDA data

EVOLVE

Primary DI
00889797016612
Brand
EVOLVE
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
49510035
Catalog number
49510035
Device description
EPS Screw Gauge
Published
2017-01-26
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTYTAPE, MEASURING, RULERS AND CALIPERS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889797016612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889797016612008897970166128897970166120889797016612

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889797023443INVISION600025012016-09-17
00889797024136INVISION600124002016-09-17
00889797024143INVISION600124012016-09-17
00889797040686NA49411XL2016-09-17
00889797040693NA49412XL2016-09-17
00889797040709NA49413XL2016-09-17
00889797057295EZ FRAMEEF0037002015-10-24
00889797058452EZ FRAME SIDEKICKEF0016002016-09-17
00889797102957NAEF002550EF0025502022-06-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118154255LEVEL ONE EXTREMITYKLS-Martin L.P.FTY2026-05-25
00810180843331Durma+ DynaRule Disposable Paper RulersDynarex CorporationFTY2026-03-24
08806373887703BENCOX Surgical InstrumentsCorentec Co., LtdFTY2026-02-23
00842071152963AMT Balloon Measuring DeviceAPPLIED MEDICAL TECHNOLOGY, INC.FTY2026-02-20
B382SD2644404000Surgical DirectSurgical Direct, Inc.FTY2026-02-16
00757770421848Bausch + LombBausch & Lomb IncorporatedFTY2026-02-11
03662663108072Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2026-02-11
03662663108089Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2026-02-11
B382SD91328410000Surgical DirectSurgical Direct, Inc.FTY2026-02-10
08681506801500SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIFTY2026-02-09
08681506801593ScharfSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIFTY2026-01-31
00847538005479Patella CaliperSYMMETRY MEDICAL INC.FTY2025-12-10
09348811038784INKAThe Trustee for KAISER FAMILY TRUSTFTY2025-12-02
00810207782599Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDFTY2025-11-24
00887868287503Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLCFTY2025-11-14
04719846016576CharderCHARDER ELECTRONIC CO., LTD.FTY2025-11-13
00763000684044Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.FTY2025-09-21
B382SD1327110040Surgical DirectSurgical Direct, Inc.FTY2025-09-09
04059453050144Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFTY2025-08-25
00757770405237Bausch + LombBausch & Lomb IncorporatedFTY2025-08-13
00757770413102Bausch + LombBausch & Lomb IncorporatedFTY2025-08-13
00757770450831Bausch + LombBausch & Lomb IncorporatedFTY2025-08-13
00757770676309Bausch + LombBausch & Lomb IncorporatedFTY2025-08-13
00757770413843Bausch + LombBausch & Lomb IncorporatedFTY2025-08-12
00757770422531Bausch + LombBausch & Lomb IncorporatedFTY2025-08-12
00757770669615Bausch + LombBausch & Lomb IncorporatedFTY2025-08-12
20197344154651MEDLINEMEDLINE INDUSTRIES, INC.FTY2025-07-28
00190776406899MillenniumAvalign Technologies, Inc.FTY2025-07-25
04059453186676Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFTY2025-07-23
B382SD1325910000Surgical DirectSurgical Direct, Inc.FTY2025-07-23