FDA.reportPublic FDA data

gSource

Primary DI
00840314269775
Brand
gSource
Company
GSOURCE LLC
Model
gS 43.5600
Catalog number
gS 43.5600
Device description
"gElevator, Cobb, 16"", Straight, 18mm, with Silicone Handle, Black, Threaded"
Published
2025-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FZSCurette, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840314269775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314269775008403142697758403142697750840314269775

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
008162518
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840314243782gSourcegS 82.4740gS 82.47402020-02-27
00840314220448gSourcegS 42.7171gS 42.71712019-12-27
00840314216854gSourcegS 40.1100gS 40.11002019-12-17
00840314222237gSourcegS 45.5033gS 45.50332020-01-02
00840314222244gSourcegS 45.5043gS 45.50432020-01-02
00840314222251gSourcegS 45.5060gS 45.50602020-01-02
00840314231598gSourcegS 59.7670gS 59.76702020-02-14
00840314242723gSourcegS 81.3716gS 81.37162020-02-26
00840314242730gSourcegS 81.3717gS 81.37172020-02-26
00840314233073gSourcegS 65.7440gS 65.74402020-02-18
00840314243874gSourcegS 82.4870gS 82.48702020-02-27
00840314246295gSourcegS 86.4420gS 86.44202020-03-03
00840314246349gSourcegS 86.4530gS 86.45302020-03-03
00840314221278gSourcegS 43.4120gS 43.41202019-12-31
00840314270344gSourcegS 40.1143gS 40.11432026-09-22
00840314269744gSourcegS 59.1800gS 59.18002025-05-05
00840314269690gSourcegS 49.2400gS 49.24002025-01-15
00840314269652gSourcegS 47.6299gS 47.62992024-10-25
00840314269638gSourcegS 82.8035gS 82.80352024-10-15
00840314269591gSourcegS 47.6050gS 47.60502024-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776431068MillenniumAvalign Technologies, Inc.FZS2026-09-21
M93071015023S10Life InstrumentsLife Instrument CorporationFZS2026-09-21
M93071015024S10Life InstrumentsLife Instrument CorporationFZS2026-09-21
M93071715021C900Life InstrumentsLife Instrument CorporationFZS2026-09-21
M93071715022C900Life InstrumentsLife Instrument CorporationFZS2026-09-21
M93071715031C900Life InstrumentsLife Instrument CorporationFZS2026-09-21
M93071715032C900Life InstrumentsLife Instrument CorporationFZS2026-09-21
00840314270290gSourceGSOURCE LLCFZS2026-08-07
00810143906592SURGIPROSSurgipros, LLCFZS2026-07-30
00810143906608SURGIPROSSurgipros, LLCFZS2026-07-30
00810143909777SURGIPROSSurgipros, LLCFZS2026-07-30
00810143909784SURGIPROSSurgipros, LLCFZS2026-07-30
00810143909807SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934136SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934143SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934150SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934167SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934174SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934181SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934198SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934204SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934211SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934228SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934235SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934242SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934259SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934266SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934273SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934280SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934297SURGIPROSSurgipros, LLCFZS2026-07-30