FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653245413
Brand
AESCULAP
Company
Aesculap AG
Model
BV585R
Catalog number
BV585R
Device description
PARKS (MODIF. GIRONA) Rectal Retractor, self-retaining, consisting of BV581R, BV582R, BV583R, BV584R, non-sterile, reusable, Set
Published
2020-08-10
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
FFORETRACTOR, SELF-RETAINING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653245413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653245413040386532454134038653245413

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. 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
Premarket exempt
true
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
09348811023612INKAThe Trustee for KAISER FAMILY TRUSTFFO2025-11-19
07898506813698QuinelatoSchobell Industrial LtdaFFO2022-12-16
10381780268437Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-10-23
10381780268420Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780268499Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269397Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269427Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269489Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269564Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269663Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269670Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269694Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269724Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269748Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269762Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269779Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269816Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780268413Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268444Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268451Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268468Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268475Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268482Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268505Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268512Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268529Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268543Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268550Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268567Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268574Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23