FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653151035
Brand
AESCULAP
Company
Aesculap AG
Model
EA887R
Catalog number
EA887R
Device description
KELLY PROCTOSCOPE 22X140MM
Published
2020-06-17
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
FFQSPECULUM, RECTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFQSpeculum, RectalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653151035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653151035040386531510354038653151035

GMDN Terms#

Term, Definition table
TermDefinition
Proctoscope, reusableAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. It is inserted into the body through the anus during proctoscopy. Anatomical images are transmitted to the user by the device by direct or magnified viewing. This device is longer than an anoscope to provide a deeper view and it is typically equipped with illumination in the distal end. 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
05055445961107SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961114SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961121SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961138SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961145SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961152SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961169SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961176SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961183SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961190SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961206SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961213SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961220SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961237SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961244SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961251SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961282SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961299SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961305SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961312SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961329SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961336SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961343SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961350SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961367SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961374SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961381SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961398SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961404SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961411SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12