FDA.reportPublic FDA data

Alliant Biotech

Primary DI
G611BIO110910
Brand
Alliant Biotech
Company
MEDISURGE LLC
Model
BIO-1-1091
Catalog number
BIO-1-1091
Device description
Soft Face Mallet Tip
Published
2024-08-16
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
GFJMallet, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFJMallet, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G611BIO110910PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical mallet headA device intended to replace the head of some types of surgical mallets and hammers. It is typically a solid cylinder of various diameters with flat ends; it is made of durable, non-splintering, synthetic polymer materials and is fixed (typically screwed using it's central screw thread) to the the distal end of the mallet. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8883071144mmorrissey@medisurge.com

Regulatory Flags#

DUNS number
119198202
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G611BIO110210Alliant BiotechBIO-1-1021BIO-1-10212024-08-16
G611BIO110220Alliant BiotechBIO-1-1022BIO-1-10222024-08-16
G611BIO110230Alliant BiotechBIO-1-1023BIO-1-10232024-08-16
G611BIO110240Alliant BiotechBIO-1-1024BIO-1-10242024-08-16
G611BIO11024B0Alliant BiotechBIO-1-1024-BBIO-1-1024-B2024-08-16
G611BIO11024C0Alliant BiotechBIO-1-1024-CBIO-1-1024-C2024-08-16
G611BIO110310Alliant BiotechBIO-1-1031BIO-1-10312024-08-16
G611BIO110320Alliant BiotechBIO-1-1032BIO-1-10322024-08-16
G611BIO110330Alliant BiotechBIO-1-1033BIO-1-10332024-08-16
G611BIO11033R0Alliant BiotechBIO-1-1033-RBIO-1-1033-R2024-08-16
G611BIO110340Alliant BiotechBIO-1-1034BIO-1-10342024-08-16
G611BIO11034R0Alliant BiotechBIO-1-1034-RBIO-1-1034-R2024-08-16
G611BIO110350Alliant BiotechBIO-1-1035BIO-1-10352024-08-16
G611BIO110360Alliant BiotechBIO-1-1036BIO-1-10362024-08-16
G611BIO110370Alliant BiotechBIO-1-1037BIO-1-10372024-08-16
G611BIO110810Alliant BiotechBIO-1-1081BIO-1-10812024-08-16
G611BIO110820Alliant BiotechBIO-1-1082BIO-1-10822024-08-16
G611BIO110830Alliant BiotechBIO-1-1083BIO-1-10832024-08-16
G611BIO110840Alliant BiotechBIO-1-1084BIO-1-10842024-08-16
G611WF110010Alliant Biotech15mm Cancellous Bone ScrewWF-1-10012024-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB71200TBS BASICSACME ENTERPRISE.GFJ2026-05-22
05055445941086SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941093SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941109SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941116SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941123SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941130SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941147SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941154SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941161SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941178SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941185SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941192SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941208SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941215SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941222SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941239SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941246SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941253SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941260SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941277SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941284SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941291SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941307SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941314SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941321SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941338SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941345SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941352SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941369SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12