FDA.report

PRO-TOE

Primary DI
00889797014434
Brand
PRO-TOE
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
45765002
Catalog number
45765002
Device description
VO AO Driver
Published
2016-09-17
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

Related Records

Contact Domains

Product Codes

CodeName
HRSPlate, fixation, bone

Product Code Classifications

CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889797014434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889797014434008897970144348897970144340889797014434

GMDN Terms

TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
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 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 DIBrandCompanyProduct codePublished
00888118145284PURE PECTUSKLS-Martin L.P.HRS2026-05-25
00888118145291PURE PECTUSKLS-Martin L.P.HRS2026-05-25
07640187463392POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, LeftBonebridge AGHRS2026-05-22
07640187463408POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, RightBonebridge AGHRS2026-05-22
07640187463415POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, LeftBonebridge AGHRS2026-05-22
07640187463422POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, RightBonebridge AGHRS2026-05-22
07640187463439POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, LeftBonebridge AGHRS2026-05-22
07640187463446POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, RightBonebridge AGHRS2026-05-22
00888118143266PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143273PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143280PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143297PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143303PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143310PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143327PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143334PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143341PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143358PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143365PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143372PURE PECTUSKLS-Martin L.P.HRS2026-03-23
10885862649690EquinoxeExactech, Inc.HRS2026-03-19
00841506141466Distal Elbow Plating SystemSKELETAL DYNAMICS L.L.C.HRS2026-03-05
05055662971552Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-03-04
05055662971569Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-03-04
08809986480521CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-03-04
00888867535053Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535077Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535091Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535114Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535138Arthrex®ARTHREX, INC.HRS2026-02-23