FDA.reportPublic FDA data

MEDLINEUNITE

Primary DI
10080196016747
Brand
MEDLINEUNITE
Company
MEDLINE INDUSTRIES, INC.
Model
MSN10011
Catalog number
MSN10011
Device description
DRILL BIT, CANN, AO/QC, HOOK SCRW, 3.0MM
Published
2020-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10080196016747PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1008019601674710080196016747

GMDN Terms#

Term, Definition table
TermDefinition
Catheter-exchange guidewire holderA sterile hand-held device intended for use during guidewire-assisted intravascular interventional procedures [e.g., percutaneous transluminal coronary angioplasty (PTCA)] to facilitate the exchange of one catheter for another (e.g., coronary angioplasty balloon catheter) while maintaining the position of the guidewire. It consists of a clip for mechanical attachment to part of the catheterization device set, and a magnetic channel through which the catheter/guidewire is passed to enable removal of the catheter while the metal guidewire is magnetically held in place. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197344235391MEDLINEMPHEPREEMIEMPHEPREEMIE2026-10-13
10197344175987MEDLINEESS7044EPESS7044EP2026-07-13
10884389112090MEDLINEEQX7012EQX70122026-10-09
10197344175963MEDLINEESS7012EPESS7012EP2026-07-13
10884389931967MEDLINEMSC7366EPMSC7366EP2026-10-09
20193489079804MEDLINEBNS128632BNS1286322026-10-09
30193489079726MEDLINEBNS111718BNS1117182026-10-09
30193489079771MEDLINEBNS119386BNS1193862026-10-09
30193489079788MEDLINEBNS119387BNS1193872026-10-09
30193489079795MEDLINEBNS120988BNS1209882026-10-09
10197344104116MEDLINEPIVBCA18125PIVBCA181252025-02-06
10197344104130MEDLINEPIVBCA20100PIVBCA201002025-02-06
10197344104147MEDLINEPIVBCA20125PIVBCA201252025-02-06
20197344024992MedlineMPH22325HCGMPH22325HCG2024-03-11
10197344042388HUDSON RCIHUD1895HUD18952026-10-08
10197344042395HUDSON RCIHUD1896HUD18962026-10-08
10653160394273MEDLINEDYND71006DYND710062026-10-08
10653160394532MEDLINEDT22100ADT22100A2026-10-08
10653160394594MEDLINEDYNDC3490ADYNDC3490A2026-10-08
10653160394709MEDLINEDYNDC3601DYNDC36012026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630894827723AVENGERMedartis AGLXH2026-10-13
07630894827730AVENGERMedartis AGLXH2026-10-13
07630894827747AVENGERMedartis AGLXH2026-10-13
00190776434762MillenniumAvalign Technologies, Inc.LXH2026-10-12
00850080243176OSTEOROD Delivery SystemBONE SOLUTIONS, INC.LXH2026-10-12
00889795150264APEX 3D Total Ankle Replacement SystemParagon 28, Inc.LXH2026-10-12
00724995225148NASTERIS CORPORATIONLXH2025-03-31
00196449010219A.L.P.S. mvX™Tyber Medical, LLCLXH2023-12-15
00196449012800A.L.P.S. mvX™Tyber Medical, LLCLXH2023-12-15
08057968716407LIGHTENED TRIAL HEAD D42 mmHPF SRLLXH2022-09-08
08057968716414LIGHTENED TRIAL HEAD D44 mmHPF SRLLXH2022-09-08
08057968716421LIGHTENED TRIAL HEAD D46 mmHPF SRLLXH2022-09-08
08057968716438LIGHTENED TRIAL HEAD D48 mmHPF SRLLXH2022-09-08
08057968716445LIGHTENED TRIAL HEAD D50 mmHPF SRLLXH2022-09-08
08057968716452LIGHTENED TRIAL HEAD D52 mmHPF SRLLXH2022-09-08
08057968716469LIGHTENED TRIAL HEAD D54 mmHPF SRLLXH2022-09-08
08057968716476LIGHTENED TRIAL HEAD D56 mmHPF SRLLXH2022-09-08
08057968716483LIGHTENED TRIAL HEAD D58 mmHPF SRLLXH2022-09-08
08055727374899FLAG RATCHET HANDLE WHITEHPF SRLLXH2022-09-05
08055727374905FLAG RATCHET HANDLE VIOLETHPF SRLLXH2022-09-05
08055727374912FLAG RATCHET HANDLE NIGHT BLUEHPF SRLLXH2022-09-05
08055727374929FLAG RATCHET HANDLE CANNULATED YELLOWHPF SRLLXH2022-09-05
08055727374936FLAG RATCHET HANDLE CANNULATED WHITEHPF SRLLXH2022-09-05
08055727374943FLAG RATCHET HANDLE CANNULATED VIOLETHPF SRLLXH2022-09-05
08055727374950FLAG RATCHET HANDLE CANNULATED NIGHT BLUEHPF SRLLXH2022-09-05
08055727374967FLAG RATCHET HANDLE CANNULATED BLUEHPF SRLLXH2022-09-05
08055727374974FLAG RATCHET HANDLE CANNULATED BLACKHPF SRLLXH2022-09-05
08055727374981FLAG RATCHET HANDLE BLUEHPF SRLLXH2022-09-05
08055727374998FLAG RATCHET HANDLE BLACKHPF SRLLXH2022-09-05
08055727375001FLAG HANDLE M8 YELLOWHPF SRLLXH2022-09-05