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
10080196320493MEDLINEMDS30201MDS302012026-09-04
10080196320516MEDLINEMDS30203MDS302032026-09-05
10197344039418HUDSON RCIHUD99001KITHUD99001KIT2026-09-04
10197344043064HUDSON RCIHUD99060KITHUD99060KIT2026-09-04
10197344043071HUDSON RCIHUD99060HUD990602026-09-04
10197344043101HUDSON RCIHUD99018KITHUD99018KIT2026-09-04
10197344043118HUDSON RCIHUD99009KITHUD99009KIT2026-09-04
10197344148332MEDLINERTDCIDDHNRTDCIDDHN2026-09-04
10197344148707MEDLINERTDCIVOMRRTDCIVOMR2026-09-04
10197344204540MEDLINEMDSDAMPLGMDSDAMPLG2026-09-04
10197344204557MEDLINEMDSDAMPMGMDSDAMPMG2026-09-04
10197344204564MEDLINEMDSDAMPXLGMDSDAMPXLG2026-09-04
10888277415010MEDLINEAEG001SAEG001S2026-09-04
10888277415027MEDLINEAEG017SAEG017S2026-09-04
10080196304752MEDLINEDYNJP2203SDYNJP2203S2016-10-14
10080196714100MEDLINEDYNJP2003DYNJP20032016-10-14
10080196894536MEDLINEDYNJP6010DYNJP60102021-01-26
10884389106280MEDLINEDYND70279DYND702792023-01-27
20888277699561MEDLINENONLV340NONLV3402020-12-04
10884389393697Medline Industries, Inc.DYNJASM1DYNJASM12019-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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