FDA.reportPublic FDA data

gSource

Primary DI
00840314243850
Brand
gSource
Company
GSOURCE LLC
Model
gS 82.4820
Catalog number
gS 82.4820
Device description
Demel Wire Guide 11 1/2" 47mm
Published
2020-11-02
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
GDFGuide, Needle, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840314243850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314243850008403142438508403142438500840314243850

GMDN Terms#

Term, Definition table
TermDefinition
Wire/ligature passer, reusableA hand-held, manual surgical instrument designed for passing a length of a flexible material/device, typically a wire, ligature, or orthopaedic graft gauge, through a surgical site by creating a pathway through tissue and facilitating the introduction and handling of the material/device. It may also be referred to as a carrier and is typically in the form of a shaft with a distal clasp, grasping arm, or cannulated hook to hold the material being passed through the tissue. 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
00840314270221gSourcegS 82.7715gS 82.77152026-03-20
00840314270238gSourcegS 82.7717gS 82.77172026-03-20
00840314270245gSourcegS 86.8120gS 86.81202026-03-20
00840314270252gSourcegS 86.8125gS 86.81252026-03-20
00840314270269gSourcegS 86.8130gS 86.81302026-03-20
00840314238511gSourcegS 75.3124gS 75.31242025-11-24
00840314238528gSourcegS 75.3250gS 75.32502025-11-24
00840314238535gSourcegS 75.3280gS 75.32802025-11-24
00840314238542gSourcegS 75.9230gS 75.92302025-11-24
00840314238559gSourcegS 75.9240gS 75.92402025-11-24
00840314238566gSourcegS 75.9250gS 75.92502025-11-24
00840314238573gSourcegS 75.9255gS 75.92552025-11-24
00840314238580gSourcegS 75.9260gS 75.92602025-11-24
00840314238597gSourcegS 75.9282gS 75.92822025-11-24
00840314238603gSourcegS 75.9300gS 75.93002025-11-24
00840314238610gSourcegS 75.9302gS 75.93022025-11-24
00840314238627gSourcegS 75.9307gS 75.93072025-11-24
00840314238634gSourcegS 75.9308gS 75.93082025-11-24
00840314238641gSourcegS 75.9309gS 75.93092025-11-24
00840314238658gSourcegS 75.9310gS 75.93102025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03662663161237PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCGDF2026-02-16
03662663161961Vital MIS Spinal Fixation SystemHighridge Medical, LLCGDF2026-02-16
00850031983014OCCIGUIDEVAULT PARAGON GROUP, INC.GDF2026-01-07
03662663244442Vital MIS Spinal Fixation SystemHighridge Medical, LLCGDF2025-12-18
03662663244466Vital MIS Spinal Fixation SystemHighridge Medical, LLCGDF2025-12-18
03662663276412Timberline Lateral Fusion SystemHighridge Medical, LLCGDF2025-12-18
03662663276429Timberline Lateral Fusion SystemHighridge Medical, LLCGDF2025-12-18
03662663276788Timberline Lateral Fusion SystemHighridge Medical, LLCGDF2025-11-17
03662663135924Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCGDF2025-11-14
20197344044792MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
20197344044808MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
00194613059095MSI Precision Specialty InstrumentsMed Saver, Inc.GDF2025-08-01
10850012846434PicoDriverLSI Solutions, Inc.GDF2025-07-19
05010058179820InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-23
05010058182639InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-23
05010058182646InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-23
05010058183643InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-23
05010058182622InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-18
05010058178953InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-05-21
05010058179943InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-05-21
04049047675808GimmiGimmi GmbHGDF2025-05-06
04049047675815GimmiGimmi GmbHGDF2025-05-06
04049047675884GimmiGimmi GmbHGDF2025-05-06
04049047675891GimmiGimmi GmbHGDF2025-05-06
04049047675907GimmiGimmi GmbHGDF2025-05-06
04049047675945GimmiGimmi GmbHGDF2025-05-06
04049047675952GimmiGimmi GmbHGDF2025-05-06
04049047675969GimmiGimmi GmbHGDF2025-05-06
04049047675976GimmiGimmi GmbHGDF2025-05-06