FDA.reportPublic FDA data

Screw Removal Kit

Primary DI
07899258695174
Brand
Screw Removal Kit
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
Sterile Screw Removal Kit - HE2.0/2.5
Catalog number
353-1000
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
07899258695174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899258695174078992586951747899258695174

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
07899258663241ACCESS FITSTRAIGHT SUTURE PASSER359-2002024-08-13
07899258663258ACCESS FITRIGHT SUTURE PASSER359-2102024-08-13
07899258663265ACCESS FITLEFT SUTURE PASSER359-2202024-08-13
07899258658292Meniscus Suture - OUT INMeniscus Suture - OUT IN354-100-0502024-01-18
07899258606637Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x10.0mm169-35-102026-07-30
07899258606644Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x12.0mm169-35-122026-07-30
07899258606651Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x14.0mm169-35-142026-07-30
07899258606668Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x16.0mm169-35-162026-07-30
07899258606675Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x18.0mm169-35-182026-07-30
07899258606682Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x20.0mm169-35-202026-07-30
07899258606699Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x22.0mm169-35-222026-07-30
07899258606705Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x24.0mm169-35-242026-07-30
07899258606712Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x26.0mm169-35-262026-07-30
07899258606729Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x28.0mm169-35-282026-07-30
07899258606736Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x30.0mm169-35-302026-07-30
07899258606743Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x32.0mm169-35-322026-07-30
07899258606750Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x34.0mm169-35-342026-07-30
07899258606767Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x35.0mm169-35-352026-07-30
07899258606774Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x36.0mm169-35-362026-07-30
07899258606781Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x38.0mm169-35-382026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701089527965AMPLITUDEAMPLITUDE SASHWB2026-07-29
03701089527972AMPLITUDEAMPLITUDE SASHWB2026-07-29
03701089531276AMPLITUDEAMPLITUDE SASHWB2026-07-29
00889024711495Z1 ExtractorZimmer, Inc.HWB2026-07-20
10603295543695ATTUNEDEPUY (IRELAND)HWB2025-10-31
00810135963411ImpactNVision Biomedical Technologies, Inc.HWB2025-09-24
00840314269737gSourceGSOURCE LLCHWB2025-05-05
00818069011031TecometTECOMET INC.HWB2023-08-10
00818069011048TecometTECOMET INC.HWB2023-08-10
00818069011055TecometTECOMET INC.HWB2023-08-10
00818069011062TecometTECOMET INC.HWB2023-08-10
00818069011079TecometTECOMET INC.HWB2023-08-10
00818069011086TecometTECOMET INC.HWB2023-08-10
00818069011093TecometTECOMET INC.HWB2023-08-10
00818069011109TecometTECOMET INC.HWB2023-08-10
00818069011116TecometTECOMET INC.HWB2023-08-10
00841435120365TecometTECOMET INC.HWB2022-10-03
00841435111226TecometTECOMET INC.HWB2020-10-09
00818069014858TecometTECOMET INC.HWB2020-10-09
00841435100688TecometTECOMET INC.HWB2020-10-09
00841435100695TecometTECOMET INC.HWB2020-10-09
00818069014339TecometTECOMET INC.HWB2020-08-20
00818069014346TecometTECOMET INC.HWB2020-08-20
00818069014353TecometTECOMET INC.HWB2020-08-20
00818069014360TecometTECOMET INC.HWB2020-08-07
00818069014377TecometTECOMET INC.HWB2020-08-07
00818069014384TecometTECOMET INC.HWB2020-08-07
00818069014391TecometTECOMET INC.HWB2020-08-07
00818069014407TecometTECOMET INC.HWB2020-08-07
00818069014414TecometTECOMET INC.HWB2020-08-07