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
10886982228185NA456.456S456456S2015-09-14
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14
10705034762852ACIS08.843.805088438052015-09-14
10705034762876ACIS08.843.806088438062015-09-14
10705034762890ACIS08.843.807088438072015-09-14

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