FDA.reportPublic FDA data

gSource

Primary DI
00840314210807
Brand
gSource
Company
GSOURCE LLC
Model
gS 30.2475
Catalog number
gS 30.2475
Device description
"Smillie Meniscotome 9"", 5mm str, shaft only for detach handle gS 30.2400"
Published
2019-12-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEGElevator, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840314210807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314210807008403142108078403142108070840314210807

GMDN Terms#

Term, Definition table
TermDefinition
Meniscus knifeA surgical instrument designed to apply pressure to and/or cut the crescent-shaped disk of fibrocartilage that borders and partly covers the articulating surfaces of the tibia and femur at the knee (meniscus). At the proximal end is a handle, sometimes T-shaped (Smillie design), that tapers to a cutting blade at the distal end. The blade is available in various designs (e.g., straight, curved, single- or double-edged) and may enable a chisel-like cutting action. The device is typically made of high-grade stainless steel. 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
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
00840314269577gSourcegS 82.7900gS 82.79002024-05-22
00840314269645gSourcegS 98.9700gS 98.97002024-10-15
00840314270290gSourcegS 51.7750gS 51.77502026-08-07
00840314269751gSourcegS 53.4800gS 53.48002025-06-16
00840314269737gSourcegS 81.8607gS 81.86072025-05-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422646MillenniumAvalign Technologies, Inc.GEG2026-08-03
00190776422851MillenniumAvalign Technologies, Inc.GEG2026-08-03
B382SD350110Surgical DirectSurgical Direct, Inc.GEG2026-08-03
B382SD38060Surgical DirectSurgical Direct, Inc.GEG2026-08-03
B382SD4833125SN0Surgical DirectSurgical Direct, Inc.GEG2026-08-03
00190776422448MillenniumAvalign Technologies, Inc.GEG2026-07-31
00810143904598SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904604SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904611SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904628SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904642SURGIPROSSurgipros, LLCGEG2026-07-30
00810143906264SURGIPROSSurgipros, LLCGEG2026-07-30
00810143906325SURGIPROSSurgipros, LLCGEG2026-07-30
00810143906370SURGIPROSSurgipros, LLCGEG2026-07-30
00810143907254SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934068SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934075SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934082SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934099SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934105SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934112SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934129SURGIPROSSurgipros, LLCGEG2026-07-30
B382SD914665600Surgical DirectSurgical Direct, Inc.GEG2026-07-27
B382SD914665630Surgical DirectSurgical Direct, Inc.GEG2026-07-27
B382SD914665700Surgical DirectSurgical Direct, Inc.GEG2026-07-27
B382SD914665730Surgical DirectSurgical Direct, Inc.GEG2026-07-27
B382SD91466578100Surgical DirectSurgical Direct, Inc.GEG2026-07-27
B382SD91467110000Surgical DirectSurgical Direct, Inc.GEG2026-07-27
B382SD91467110010Surgical DirectSurgical Direct, Inc.GEG2026-07-27
B382SD91467110020Surgical DirectSurgical Direct, Inc.GEG2026-07-27