FDA.reportPublic FDA data

Medline

Primary DI
20193489104858
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
FMDIS01
Catalog number
FMDIS01
Device description
DISIMPACTOR, FECAL IMPACTION, MEDLINE
Published
2024-04-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FHBHOOK, GASTRO-UROLOGY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHBHook, Gastro-UrologyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30193489104855PackageGS15In Commercial Distribution
20193489104858PrimaryGS10
10193489104851Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3019348910485530193489104855
2019348910485820193489104858
1019348910485110193489104851

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue surgical hook, single-useA hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
3
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196299850MEDLINEMSC9614EPMSC9614EP2026-10-22
10193489109702NAMICDYNJCAPMF1DYNJCAPMF12026-10-22
10884389119310MEDLINEMSC1513MSC15132026-10-22
10080196317462MEDLINEMSC1510MSC15102026-10-21
10884389111499MEDLINEMSC1528MSC15282026-10-21
10193489068245NAMIC90500050905000502023-12-21
10197344104178MEDLINEPIVBCA24056PIVBCA240562026-10-16
10197344174423MEDLINEDYNJP1048DYNJP10482026-10-16
10197344219254MEDLINEDYNDSCL1000RDYNDSCL1000R2026-10-16
20197344223333MEDLINEL2USA2XLL2USA2XL2026-10-16
20197344223340MEDLINEL2USA3XLL2USA3XL2026-10-16
20197344223357MEDLINEL2USALL2USAL2026-10-16
20197344223364MEDLINEL2USALFL2USALF2026-10-16
20197344223371MEDLINEL2USAXLL2USAXL2026-10-16
20197344225894MEDLINEDYND30363DYND303632026-10-16
10193489194531MEDLINEDYNDV2284DYNDV22842020-04-16
10193489194692MEDLINEDYNDV2310DYNDV23102020-04-16
10653160353577MEDLINEART1010BART1010B2022-05-31
10653160362074MEDLINEART20G17501ART20G175012023-07-21
10888277194847MedlineMDS9913DMMDS9913DM2016-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995295530V. MuellerSTERIS Deutschland GmbHFHB2026-09-25
30193489104855MedlineMEDLINE INDUSTRIES, INC.FHB2024-04-25
G586UR6105490Novo SurgicalNOVO SURGICAL, INC.FHB2023-12-18
G586UR96105400Novo SurgicalNOVO SURGICAL, INC.FHB2023-12-18
G586UR96105490Novo SurgicalNOVO SURGICAL, INC.FHB2023-12-18
00190776303181MillenniumAvalign Technologies, Inc.FHB2023-11-16
00190776305116MillenniumAvalign Technologies, Inc.FHB2023-06-23
00842331159404Novo Surgical Inc. NOVO SURGICAL, INC.FHB2022-11-13
00192896075344PRATT CRYPT HOOKSONTEC INSTRUMENTS, INC.FHB2018-09-20
00192896020245PRATT CRYPT HOOKSONTEC INSTRUMENTS, INC.FHB2018-09-14
00192896020252PRATT CRYPT HOOKSONTEC INSTRUMENTS, INC.FHB2018-09-14
00192896020269PRATT CRYPT HOOKSONTEC INSTRUMENTS, INC.FHB2018-09-14
10885403050183V. MuellerSTERIS CORPORATIONFHB2018-08-30