FDA.reportPublic FDA data

gSource

Primary DI
M7554984000
Brand
gSource
Company
GSOURCE LLC
Model
gS 49.8400
Catalog number
gS 49.8400
Device description
Carroll Tendon Pulling Fcps 4 1/2" cvd
Published
2020-01-03
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
GENForceps, General & Plastic Surgery
HTDForceps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7554984000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, alligator, reusableA long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a reusable device intended to be sterilized prior to use.

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
00840314265241gSourcegS 86.9711gS 86.97112024-12-06
00840314216854gSourcegS 40.1100gS 40.11002019-12-17
00840314270276gSourcegS 33.0310gS 33.03102026-05-20
00840314270283gSourcegS 33.0311gS 33.03112026-05-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776395360MillenniumAvalign Technologies, Inc.HTD2026-07-14
B382SD906201100Surgical DirectSurgical Direct, Inc.HTD2026-07-14
B382SD906202100NC0Surgical DirectSurgical Direct, Inc.HTD2026-07-14
B382SD914264010Surgical DirectSurgical Direct, Inc.GEN2026-07-13
B382SD91705515T0Surgical DirectSurgical Direct, Inc.HTD2026-07-13
B382SD91705525T0Surgical DirectSurgical Direct, Inc.HTD2026-07-13
B382SD9183761030Surgical DirectSurgical Direct, Inc.HTD2026-07-13
B382SD9184571000Surgical DirectSurgical Direct, Inc.HTD2026-07-13
B382SD9184932000Surgical DirectSurgical Direct, Inc.HTD2026-07-13
00810158219960PRINCETONPrinceton Medical Group, Inc.HTD2026-07-10
00810158219977PRINCETONPrinceton Medical Group, Inc.HTD2026-07-10
00810158219991PRINCETONPrinceton Medical Group, Inc.HTD2026-07-10
00850088713008PRINCETONPrinceton Medical Group, Inc.HTD2026-07-10
00850083275075Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275082Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275099Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275105Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275112Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275129Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275136Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275143Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275174Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275181Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275198Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275204Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275211Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275228Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275280Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275310Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275334Intrace USAPILOTIS TECH LLCGEN2026-07-03