FDA.reportPublic FDA data

ASP MEDICAL

Primary DI
00840216104372
Brand
ASP MEDICAL
Company
Asp Global, LLC
Model
SGT401
Device description
REMOVER SKIN STAPLER EACHES PER CASE 200, 1/EA,200/CS
Published
2022-08-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GDTStaple, Removable (Skin)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDTStaple, Removable (Skin)General, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840216104372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216104372008402161043728402161043720840216104372

GMDN Terms#

Term, Definition table
TermDefinition
Skin staple remover, single-useA hand-held manual surgical instrument intended to be used to remove skin staples after the healing process has progressed sufficiently to permit the borders of the wound or incision to remain together without assistance. It is a tweezers-like device made of metallic or synthetic polymer materials with blades at the distal end activated by lever action designed for grasping, opening, and removing surgical staples. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
080361159
Device count
1
Premarket exempt
true
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840216127869Northside HospitalNSAMK-052026-07-23
00840216129290Quest DiagnosticsQD11X16KPAP2026-07-17
00840216129801LabCorpLC13X22BIO2026-07-17
00840216108738ASP MEDICALFMT630V2020-10-21
00840216108943ASP MEDICALFMT7002020-10-21
00840216108967ASP MEDICALFMT7102020-10-21
00840216108974ASP MEDICALFMT6552020-10-21
00840216108998ASP MEDICALFMT645V2020-10-21
00840216109018ASP MEDICALFMT640V2020-10-21
00840216109025ASP MEDICALFMT635V2020-10-21
00840216110922ASP MEDICALFMT605HEART2022-02-09
00840216129245PRIMOSC101P-K2026-05-21
00840216129252PRIMOSC201P-K2026-05-21
00840216129269ASP GLOBAL PRIMOAFOVERLAY-B-K2026-05-21
00840216129276ASP GLOBAL PRIMOAFOVERLAY-A-K2026-05-21
00840216120037ASP MEDICAL1038SM-ASP2022-08-08
00840216120044ASP MEDICAL1038LG-ASP2022-08-08
00840216120051ASP MEDICAL1038XL-ASP2022-08-08
00840216120068ASP MEDICAL10382XL-ASP2022-08-08
00840216117600ASP MEDICAL1206BG22022-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00661392055148LSL HEALTHCARELSL Industries, LLCGDT2025-10-30
10197344111053MEDLINEMEDLINE INDUSTRIES, INC.GDT2025-03-05
20197344111050MEDLINEMEDLINE INDUSTRIES, INC.GDT2025-03-05
10080196846924Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GDT2025-02-16
40080196846925Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GDT2025-02-16
00192896120228Michel Wound ClipsSONTEC INSTRUMENTS, INC.GDT2024-10-15
14026704741943WECKTELEFLEX INCORPORATEDGDT2024-07-17
24026704741940WECKTELEFLEX INCORPORATEDGDT2024-07-17
04717480900374Taiwan SurgicalTAIWAN SURGICAL CORPORATIONGDT2023-08-02
04719880180493Haritex CorporationHARITEX CORPORATIONGDT2023-06-19
10841767102944Trinity Sterile, Inc.Trinity Sterile, Inc.GDT2023-03-09
00841767102947Trinity Sterile, Inc.Trinity Sterile, Inc.GDT2023-03-09
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