FDA.reportPublic FDA data

Mueller Aircast Ankle Brace Left White

Primary DI
00074676456102
Brand
Mueller Aircast Ankle Brace Left White
Company
Mueller Sports Medicine, Inc.
Model
4561
Catalog number
4561
Device description
AIRCAST ANKLE BRACE - LEFT, WHITE
Published
2022-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZFSPLINT, EXTREMITY, INFLATABLE, EXTERNAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZFSplint, Extremity, Inflatable, ExternalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00074676456102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00074676456102000746764561020746764561020074676456102

GMDN Terms#

Term, Definition table
TermDefinition
Inflatable extremity splintA non-sterile sleeve intended to be placed around an arm or leg and inflated to immobilize and protect the limb. It is typically used by emergency medical services (EMS) as a temporary measure in emergencies, e.g., accidents and motor vehicle crashes, to stabilize the limb for transport to a hospital. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(608)643-8530Regulatory@muellersportsmed.com

Regulatory Flags#

DUNS number
006426316
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00074676456607Mueller Aircast Ankle Brace Right White456645662022-08-31
00074676006925Mueller Sports MedicineM2M22022-08-31
00074676007045Mueller Sports MedicineRG100RG1002022-08-31
00074676007076Mueller Sports MedicineRG200SMRG200SM2022-08-31
00074676007106Mueller Sports MedicineRG200MDRG200MD2022-08-31
00074676007137Mueller Sports MedicineRG200LGRG200LG2022-08-31
00074676006956Mueller Sports MedicineM2RG200SMM2RG200SM2022-08-31
00074676006987Mueller Sports MedicineM2RG200MDM2RG200MD2022-08-31
00074676007014Mueller Sports MedicineM2RG200LGM2RG200LG2022-08-31
00074676007168Mueller Sports MedicineRG500RG5002022-08-31
00074676007199Mueller Sports MedicineRG400RG5002022-08-31
00074676007229Mueller Sports MedicineRG300RG4002022-08-31
00074676006802Mueller Sports MedicineM4M42022-08-31
00074676191218Mueller Nasal Sponges1912011912012022-08-31
00074676191225Mueller Nasal Sponges1912021912022022-08-31
00074676912219Mueller Nasal Plugs1912211912212022-08-31
00074676235813MUELLER KINSIOLOGY EASY FIT PRE-CUT NECK23581235812022-10-15
00074676235820MUELLER KINSIOLOGY EASY FIT PRE-CUT ARCH23582235822022-10-15
00074676235837MUELLER KINESIOLOGY EASY FIT PRE-CUT CALF/ANKLE TAPE23583235832022-10-15
00074676235844MUELLER KINESIOLOGY EASY FIT PRE-CUT BK23584235842022-10-15

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