FDA.reportPublic FDA data

gSource

Primary DI
M75550613009
Brand
gSource
Company
GSOURCE LLC
Model
gS 50.6130
Catalog number
gS 50.6130
Device description
"Keyes Punch 4"" 4mm"
Published
2020-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LRYPunch, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRYPunch, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M75550613009PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Skin-coring punch, reusableA hand-held manual surgical instrument designed to cut out (core) sections of skin as part of a dermatological procedure to remove skin lesions or to obtain skin-tissue specimens. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when pressed into the skin surface and gently rotated will penetrate and cut through the skin allowing that section to be removed. It is typically metallic and is available in various cutting head sizes; it is not a biopsy gun. 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
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
00840314238627gSourcegS 75.9307gS 75.93072025-11-24
00840314238634gSourcegS 75.9308gS 75.93082025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04946329039580Kerrison Rongeur 150 x 2 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039597Kerrison Rongeur 150 x 3 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039603Kerrison Rongeur 150 x 4 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039610Kerrison Rongeur 150 x 5 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039627Kerrison Rongeur 180 x 3 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039634Kerrison Rongeur 180 x 4 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039641Kerrison Rongeur 180 x 5 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039658Kerrison Rongeur 180 x 1 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
00846338005801KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005818KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005825KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005832KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005849KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005856KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005870KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005887KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005894KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005900KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005924KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005931KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005948KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005955KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005962KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005979KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005986KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338007119Endiscope and accessoriesELLIQUENCE, LLCLRY2026-06-02
10304040193270Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
10304040193287Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
10304040193294Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
10304040193300Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26