FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653130382
Brand
AESCULAP
Company
Aesculap AG
Model
JK444
Catalog number
JK444
Device description
Bottom, without base perforation, Standard 1/1, outer length: 592 mm, outer width: 274 mm, outer heigth: 187 mm, inner length: 544 mm, inner width: 258 mm, inner heigth: 172 mm
Published
2016-05-19
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
FRGWrap, sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653130382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653130382040386531303824038653130382

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038653033997AESCULAPDC230RDC230R2020-06-17
04038653034321AESCULAPDE112RDE112R2020-06-17
04038653034369AESCULAPDE116RDE116R2020-06-17
04038653034376AESCULAPDE117RDE117R2020-06-17
04038653034406AESCULAPDE120RDE120R2020-06-17
04038653034901AESCULAPDE676RDE676R2020-06-17
04046963116194S4 CERVICALFW028UFW028U2020-08-24
04046963794248ELAN 4GA768GA7682020-04-24
04046963935184HI-LINE XXSGE813SUGE813SU2020-04-24
04046963935191HI-LINE XXSGE814SUGE814SU2020-04-24
04046963966362ELAN 4GA767GA7672020-04-24
04046964054907ELAN 4GA715RGA715R2020-04-24
04046964076664AESCULAPGE812SUGE812SU2020-04-24
04046964526213ECCOSGB068RGB068R2020-04-24
04038653013845AESCULAPOP297ROP297R2017-07-31
04038653081141AESCULAPOP913OP9132016-09-23
04038653081158AESCULAPOP914OP9142020-08-10
04038653013852AESCULAPOP298ROP298R2020-04-17
04046963730109AESCULAPOP923OP9232019-04-30
04046955273508AICONJJ612JJ6122022-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08404535029437Brasseler USAPeter Brasseler Holdings, LLCFRG2026-05-13
08404535025927Brasseler USAPeter Brasseler Holdings, LLCFRG2026-05-01
08404535015003Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535019100Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535025217Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535025248Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535025279Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
10197344140008MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344140015MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344140022MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344149018MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344149025MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344149032MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10198459366277MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FRG2025-06-16
10197344695331MEDLINEMEDLINE INDUSTRIES, INC.FRG2024-09-26
10197344695348MEDLINEMEDLINE INDUSTRIES, INC.FRG2024-09-26
10197344695355MEDLINEMEDLINE INDUSTRIES, INC.FRG2024-09-26
10197344695362MEDLINEMEDLINE INDUSTRIES, INC.FRG2024-09-26
10197344695379MEDLINEMEDLINE INDUSTRIES, INC.FRG2024-09-26
10304040172046Henry ScheinHENRY SCHEIN, INC.FRG2023-09-08
10304040172053Henry ScheinHENRY SCHEIN, INC.FRG2023-09-08
10686864044786Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
10686864044793Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
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10686864044816Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
10686864044823Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
10686864044830Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
10686864044847Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
H66810503101PrehmaKeystone IndustriesFRG2023-02-20
H66810504101PrehmaKeystone IndustriesFRG2023-02-20