FDA.reportPublic FDA data

gSource

Primary DI
00840314269737
Brand
gSource
Company
GSOURCE LLC
Model
gS 81.8607
Catalog number
gS 81.8607
Device description
gForceps, T-Rex Screw Extraction, 8", Non-Slip, Self-Centering
Published
2025-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00840314269737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314269737008403142697378403142697370840314269737

GMDN Terms#

Term, Definition table
TermDefinition
Screw extractor, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
008162518
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
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
00840314269751gSourcegS 53.4800gS 53.48002025-06-16
00840314269584gSourcegS 82.7910gS 82.79102024-05-22
00840314263261gSourcegS 86.7506gS 86.75062026-07-24
00840314263278gSourcegS 86.7516gS 86.75162026-07-24
00840314263285gSourcegS 86.7571gS 86.75712026-07-24
00840314263353gSourcegS 86.7581gS 86.75812026-07-24
00840314263421gSourcegS 86.7591gS 86.75912026-07-24
00840314263704gSourcegS 86.9401gS 86.94012026-07-24
00840314263773gSourcegS 86.9451gS 86.94512026-07-24
00840314263841gSourcegS 86.9461gS 86.94612026-07-24
00840314233066gSourcegS 65.7431gS 65.74312020-02-18
00840314263636gSourcegS 86.9391gS 86.93912026-07-17
00840314264190gSourcegS 86.9521gS 86.95212026-07-17
00840314264268gSourcegS 86.9531gS 86.95312026-07-17
00840314264404gSourcegS 86.9551gS 86.95512026-07-17
00840314264473gSourcegS 86.9561gS 86.95612026-07-17
00840314264541gSourcegS 86.9571gS 86.95712026-07-17
00840314264619gSourcegS 86.9581gS 86.95812026-07-17
00840314264688gSourcegS 86.9591gS 86.95912026-07-17
00840314265241gSourcegS 86.9711gS 86.97112024-12-06

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
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
00863176000324FIBULINKSynthes GmbHHWB2020-03-26