FDA.report

ASP MEDICAL

Primary DI
00840216102446
Brand
ASP MEDICAL
Company
Asp Global, LLC
Model
FKT455
Device description
KELLY HEMOSTAT FORCEPS STRAIGHT 5.5IN, 1/EA,10/PK,50/CS
Published
2022-08-11
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
HRQHemostat

Product Code Classifications

CodeDeviceSpecialtyClass
HRQHemostatGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840216102446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216102446008402161024468402161024460840216102446

GMDN Terms

TermDefinition
Pressure bandage, non-latex, single-useA strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. 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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Primary DIBrandCompanyProduct codePublished
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00810207781936Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781943Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781950Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
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00810207781974Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781981Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781998Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782001Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782018Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
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00810207782117Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
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