FDA.reportPublic FDA data

NA

Primary DI
10886982199461
Brand
NA
Company
Synthes GmbH
Model
394.052
Catalog number
394052
Device description
WRIST COVER
Published
2016-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IPMCOVER, LIMB

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPMCover, LimbPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982199461PrimaryGS10
H6793940520SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698219946110886982199461

GMDN Terms#

Term, Definition table
TermDefinition
Limb-worn device hygienic coverA device made of fabric or harder materials designed to cover an external prosthetic or orthotic device worn on a limb (e.g., cast, foot orthosis), or an external fixation system for a limb, primarily to function as a hygienic barrier to protect the device and patient from contamination; it is not intended to be applied directly to the limb for a therapeutic purpose. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887587078540NASD03.501.442SD035014422026-07-29
10886982362179NASD03.043.006SD030430062026-07-24
10887587078557NASD03.503.067SD035030672026-07-24
10887587078564NASD03.503.072SD035030722026-07-24
10705034712307NA03.604.002036040022016-12-31
10705034712802NA03.606.011036060112016-12-31
10705034714592NA03.613.012036130122016-12-31
10705034767819VentroFix304.8343048342016-12-31
10705034768939NA314.0643140642016-12-31
10705034768960Click'X314.0673140672016-12-31
10705034768977Click'X314.0683140682016-12-31
10705034768984Click'X314.0693140692016-12-31
10705034769646NA328.0263280262016-12-31
10705034772608NA388.3643883642016-12-31
10705034775401NA389.2883892882016-12-31
10705034777375NA394.5853945852016-12-31
20705034764051NA292.0202920202019-08-29
00863176000317FIBULINKFGS-1100FGS11002020-03-26
00863176000324FIBULINKFGS-1300FGS13002020-03-26
00863176000300FIBULINKFGS-1000FGS10002017-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00636257044988MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046197MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046203MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046210MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046463MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046470MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046487MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046494MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046500MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046517MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046524MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046531MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046548MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046555MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046562MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046579MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046586MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046593MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046609MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046616MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046623MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046630MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046647MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046654MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046661MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046678MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046685MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046692MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046708MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046715MEDIMEDI MANUFACTURING, INC.IPM2025-10-03