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
10080196144310MEDLINEDYNDX51813DYNDX518132026-06-08
10884389123997MEDLINEDYNDX50251DYNDX502512026-06-08
10080196301904MedlineMDS10781MDS107812016-10-14
10080196301898MedlineMDS10780MDS107802016-10-14
10888277419452MEDLINEMDTZ1068516ABMDTZ1068516AB2016-10-14
00888277719081RexallDG11009803DG110098032026-06-03
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11

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