FDA.reportPublic FDA data

gSource

Primary DI
00840314223425
Brand
gSource
Company
GSOURCE LLC
Model
gS 49.8350
Catalog number
gS 49.8350
Device description
"Kleinert-Kutz Tendon Retr 8"" serr 1x2"
Published
2020-01-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840314223425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314223425008403142234258403142234250840314223425

GMDN Terms#

Term, Definition table
TermDefinition
Tendon approximatorOne of a pair or set of surgical instruments used to grasp the torn or resected portions of a tendon to hold the portions in apposition for the purpose of reattaching one portion to the other in order to repair the structure. Also, an instrument used to grasp a tendon, or separated parts of a tendon, to position it in a surgical opening. 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
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
00840314216854gSourcegS 40.1100gS 40.11002019-12-17
00840314270276gSourcegS 33.0310gS 33.03102026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776404192MillenniumAvalign Technologies, Inc.LXH2026-07-24
00810135961271ToejackNVision Biomedical Technologies, Inc.LXH2026-07-24
00840314263261gSourceGSOURCE LLCLXH2026-07-24
00840314263278gSourceGSOURCE LLCLXH2026-07-24
00840314263285gSourceGSOURCE LLCLXH2026-07-24
00840314263353gSourceGSOURCE LLCLXH2026-07-24
00840314263421gSourceGSOURCE LLCLXH2026-07-24
00840314263704gSourceGSOURCE LLCLXH2026-07-24
00840314263773gSourceGSOURCE LLCLXH2026-07-24
00840314263841gSourceGSOURCE LLCLXH2026-07-24
00889024709195DRILL MEASURING SLEEVEBiomet Orthopedics, LLCLXH2026-07-24
07640221373694SCALASpineArt SALXH2026-07-24
07640221373700SCALASpineArt SALXH2026-07-24
10886982362179NASynthes GmbHLXH2026-07-24
B382SD9141071020Surgical DirectSurgical Direct, Inc.LXH2026-07-24
B382SD9141071030Surgical DirectSurgical Direct, Inc.LXH2026-07-24
B382SD9141071040Surgical DirectSurgical Direct, Inc.LXH2026-07-24
00840097534206Velora Acetabular System InstrumentationRestor3d, Inc.LXH2026-07-23
00840097534923Veritas InstrumentationRestor3d, Inc.LXH2026-07-23
00840097534930Veritas InstrumentationRestor3d, Inc.LXH2026-07-23
00818720013398SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013404SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013411SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013428SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013435KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00818720013442KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00850075111121NativeINS ORTHO INC.LXH2026-07-22
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21