FDA.reportPublic FDA data

gSource

Primary DI
M7557323300
Brand
gSource
Company
GSOURCE LLC
Model
gS 73.2330
Catalog number
gS 73.2330
Device description
Walton Cast Spreader 9"
Published
2020-02-24
Public version status
New
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
GADRetractor
LGGInstrument, Cast Application/Removal, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1
LGGInstrument, Cast Application/Removal, ManualOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7557323300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cast spreaderA hand-operated surgical instrument with specially designed blades used to separate and spread hardened plaster, i.e., that which has already been used to form a cast around a patient's limb or body part. It is designed like a large size forceps with flat serrated (serrated on the outer edge) blades that may be exchangeable and which are wedge-shaped (thin at the working end). These blades are prised between the cut plaster cast and pressure is exerted upon the handles by squeezing them together, forcing the plaster cast to separate. It 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
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423551MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776423742MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776423759MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776423766MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776423773MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776423780MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776424411MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776424428MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776424442MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776424480MillenniumAvalign Technologies, Inc.GAD2026-08-07
B382SD484600Surgical DirectSurgical Direct, Inc.GAD2026-08-07
G4533315010BC0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-08-07
G4533315012BC0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-08-07
00190776422615MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422691MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422707MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422714MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422776MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422882MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422905MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422264MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422288MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422301MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422530MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422547MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422554MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422561MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422578MillenniumAvalign Technologies, Inc.GAD2026-07-31
B382S349571000Surgical DirectSurgical Direct, Inc.GAD2026-07-31
00199150083107Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-07-30