FDA.reportPublic FDA data

Screw Removal Kit

Primary DI
07899258695181
Brand
Screw Removal Kit
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
Sterile Screw Removal Kit - HE3.5
Catalog number
353-2000
Published
2026-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWBExtractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899258695181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899258695181078992586951817899258695181

GMDN Terms#

Term, Definition table
TermDefinition
Screw extractor, single-useA hand-held manual surgical tool designed to remove implanted screws that have a damaged screw recess by self-tapping into the defective recess/head and providing sufficient grip to rotate and remove the screw in the normal way. It typically has a conical tip. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
900865213
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899258654799Stitch - Suture Wires and Tapes333-239-AB1226CI2026-08-27
07899258654805Stitch - Suture Wires and Tapes333-239-PB1226CI2026-08-27
07899258654812Stitch - Suture Wires and Tapes333-20-B2026-08-27
07899258654829Stitch - Suture Wires and Tapes333-20-AB2026-08-27
07899258657141Stitch - Suture Wires and Tapes333-239-B1226CI2026-08-27
07899258665764Stitch - Suture Wires and Tapes333-536-AB1248CO2026-08-27
07899258665771Stitch - Suture Wires and Tapes333-536-B1248CO2026-08-27
07899258665795Stitch - Suture Wires and Tapes333-536-PB1248CO2026-08-27
07899258665863Stitch - Suture Wires and Tapes333-2-018-AB1226CI2026-08-27
07899258665870Stitch - Suture Wires and Tapes333-2-018-B1226CI2026-08-27
07899258665894Stitch - Suture Wires and Tapes333-2-018-PB1226CI2026-08-27
07899258665962Stitch - Suture Wires and Tapes333-13-AB2026-08-27
07899258665986Stitch - Suture Wires and Tapes333-13-B2026-08-27
07899258697864Stitch - Suture Wires and Tapes333-2-018-A1226CI2026-08-27
07899258697871Stitch - Suture Wires and Tapes333-2-090-AB1226CI2026-08-27
07899258697888Stitch - Suture Wires and Tapes333-2-090-PB1226CI2026-08-27
07899258697895Stitch - Suture Wires and Tapes333-2-090-B1226CI2026-08-27
07899258697901Stitch - Suture Wires and Tapes333-2-090-A1226CI2026-08-27
07899258698038Stitch - Suture Wires and Tapes333-239-A1226CI2026-08-27
07899258698045Stitch - Suture Wires and Tapes333-290-AB12265R2026-08-27

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