FDA.report

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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GDTStaple, Removable (Skin)

Product Code Classifications

CodeDeviceSpecialtyClass
GDTStaple, Removable (Skin)General, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840216104372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216104372008402161043728402161043720840216104372

GMDN Terms

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
Ethylene Oxide

Regulatory Flags

DUNS number
080361159
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840216128262ASP GLOBALEGT3052025-11-20
00840216128286ASP GLOBALEGT3072025-11-20
00840216128804ASP GLOBAL PRIMOAFTS012025-06-30
00840216128279ASP GLOBALEGT3062025-06-17
00840216128293ASP GLOBALEGT3082025-06-17
00840216128842CARDINAL HEALTH AD6X10BILH2025-06-17
00840216128606LAPCORP LC4X6EZQ2025-05-13
00840216128613LAPCORP LC9X12MTL2025-05-13
00840216128163QUEST DIAGNOSTICSQD6.75X11AD2024-11-22
00840216127753ASP MEDICALMRT8002024-09-12
00840216128033ASP MEDICALMRACUP12024-09-12
20840216127566PRIMOAFTMATT2024-08-12
00840216120808PRIMOGGS3660TBH-K2024-03-05
00840216120853PRIMOGGS5670TBH-K2024-03-05
00840216121898PRIMOGGTS142024-03-05
00840216124509PRIMOGGTS13-K2024-03-05
00840216124516PRIMOGGTS14-5-K2024-03-05
00840216122697PRIMOAFPUMP2024-03-01
00840216125124PRIMOHB2002024-03-01
00840216125131PRIMOHB200B2024-03-01

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24026704741940WECKTELEFLEX INCORPORATEDGDT2024-07-17
04717480900374Taiwan SurgicalTAIWAN SURGICAL CORPORATIONGDT2023-08-02
04719880180493Haritex CorporationHARITEX CORPORATIONGDT2023-06-19
00841767102947Trinity Sterile, Inc.Trinity Sterile, Inc.GDT2023-03-09
00850018777025microMendKitotech Medical IncGDT2022-12-08
00850018777049microMend PROKitotech Medical IncGDT2022-12-08
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00850018777001microMend PROKitotech Medical IncGDT2022-12-08
00850018777216microMend PROKitotech Medical IncGDT2022-12-08
00850018777094microMend PROKitotech Medical IncGDT2022-12-08
00850018777155microMend PROKitotech Medical IncGDT2022-12-08
00850018777179microMend PROKitotech Medical IncGDT2022-12-08
04719880180387NAHARITEX CORPORATIONGDT2022-12-07
04719880180394NAHARITEX CORPORATIONGDT2022-12-05
20801902192077ARROWTELEFLEX INCORPORATEDGDT2022-11-29
40195327227716Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GDT2022-08-28
40195327234530Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GDT2022-08-28
00840216104389ASP MEDICALAsp Global, LLCGDT2022-08-15
40888277071828Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GDT2022-08-04
00192896107472Michel Wound ClipsSONTEC INSTRUMENTS, INC.GDT2021-04-14
10850010207190BandGrip® Micro-Anchor® Skin ClosureBANDGRIP INC.GDT2021-03-01
20653405037108REFLEXConmed CorporationGDT2020-11-21
50885632126244MediChoiceOWENS & MINOR DISTRIBUTION, INC.GDT2020-10-08