FDA.reportPublic FDA data

restor3d Disposable Instrument, Wedge Trial

Primary DI
00840097502755
Brand
restor3d Disposable Instrument, Wedge Trial
Company
Restor3d
Model
6100-002-22140611
Device description
Disposable Trial, Cotton Wedge 002, Anatomic Footprint, 6mm Thickness
Published
2021-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840097502755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097502755008400975027558400975027550840097502755

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, single-useA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080819836
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
true
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
00840097502731restor3d Disposable Instrument, Wedge Trial6100-002-221404072021-07-16
00840097502748restor3d Disposable Instrument, Wedge Trial6100-002-221405092021-07-16
00840097502762restor3d Disposable Instrument, Wedge Trial6100-002-221408132021-07-16
00840097502779restor3d Osteotomy Wedge1100-002-221404072021-07-16
00840097502786restor3d Osteotomy Wedge1100-002-221405092021-07-16
00840097502793restor3d Osteotomy Wedge1100-002-221406112021-07-16
00840097502809restor3d Osteotomy Wedge1100-002-221408132021-07-16
00840097500188restor3d Osteotomy Wedge1101-ADAS-00-151606182019-12-16
00840097500195restor3d Osteotomy Wedge1101-ADAS-00-181608182019-12-16
00840097500201restor3d Osteotomy Wedge1101-ADAS-00-181610182019-12-16
00840097500218restor3d Osteotomy Wedge1101-ADAS-00-181612182019-12-16
00840097500225restor3d Osteotomy Wedge1101-ADAS-00-151806182019-12-16
00840097500232restor3d Osteotomy Wedge1101-ADAS-00-201808182019-12-16
00840097500249restor3d Osteotomy Wedge1101-ADAS-00-201810182019-12-16
00840097500256restor3d Osteotomy Wedge1101-ADAS-00-201812182019-12-16
00840097500263restor3d Osteotomy Wedge1101-ADAS-00-152006182019-12-16
00840097500270restor3d Osteotomy Wedge1101-ADAS-00-222008182019-12-16
00840097500287restor3d Osteotomy Wedge1101-ADAS-00-222010182019-12-16
00840097500294restor3d Osteotomy Wedge1101-ADAS-00-222012182019-12-16
00840097500300restor3d Osteotomy Wedge1100-ADAS-00-161404072019-12-16

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Primary DI, Brand, Company table
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B382SD480090Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD4834330Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
00190776407391MillenniumAvalign Technologies, Inc.LXH2026-07-31
00840606191579Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
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