FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653151004
Brand
AESCULAP
Company
Aesculap AG
Model
EA863C
Catalog number
EA863C
Device description
BENSAUDE ANUSCOPE 20MMX55M DIAM.
Published
2020-04-21
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
EXXPROBE, RECTAL, NON-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXXProbe, Rectal, Non-PoweredGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653151004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653151004040386531510044038653151004

GMDN Terms#

Term, Definition table
TermDefinition
Rectal speculumA hand-held manual surgical instrument intended to be used to expand or stretch the rectal orifice/canal after it is inserted and opened. It is comprised of two arms joined at a pivot point and is available in various sizes, shapes, and contours; it is usually made of stainless steel. The instrument is used for examination or for the insertion of other instrumentation. 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
04046964680878COREHIP EXTENDEDNK1126TNK1126T2020-08-10
04046964681028COREHIP EXTENDEDNK1131TNK1131T2020-08-10
04046964681127COREHIP PRIMARYNK1201KNK1201K2020-08-10
04046964681189COREHIP PRIMARYNK1207KNK1207K2020-08-10
04046964681301COREHIP PRIMARYNK1209KNK1209K2020-08-10
04046964681349COREHIP PRIMARYNK1221KNK1221K2020-08-10
04046964681363COREHIP PRIMARYNK1223KNK1223K2020-08-10
04046964681387COREHIP PRIMARYNK1225KNK1225K2020-08-10
04046964681400COREHIP PRIMARYNK1227KNK1227K2020-08-10
04046964681424COREHIP PRIMARYNK1229KNK1229K2020-08-10
04046964681462COREHIP PRIMARYNK1241KNK1241K2020-08-10
04046964681486COREHIP PRIMARYNK1243KNK1243K2020-08-10
04046964681509COREHIP PRIMARYNK1245KNK1245K2020-08-10
04046964681523COREHIP PRIMARYNK1247KNK1247K2020-08-10
04046964681547COREHIP PRIMARYNK1249KNK1249K2020-08-10
04046963929435NOVOCARTFR719RFR719R2020-08-24
04046963933357NOVOCARTFR651RFR651R2020-08-24
04038653289509NOVOCARTFR661RFR661R2020-08-10
04046963565992NOVOCARTFR660SUFR660SU2020-04-24
04046963939588NOVOCARTFR744RFR744R2020-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613026622MSI Precision Specialty InstrumentsMed Saver, Inc.EXX2025-08-01
04049047024408GimmiGimmi GmbHEXX2025-04-16
04049047024477GimmiGimmi GmbHEXX2025-04-16
00840306830778Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-07-19
00840306830341Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-07-12
00840306830358Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-07-12
00840306830365Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-07-12
00840183526962BR Surgical, LLCBR Surgical, LLCEXX2024-05-29
00840306826832Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-05-10
00840306824166Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-04-29
00840306821684Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-04-08
00840306821691Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-04-08
00840306806728Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-02-23
00840306807336Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-02-23
G586UR96105210Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-19
G586UR96105610Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-19
G586UR6105520Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-18
G586UR96105520Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-18
G586UR96105530Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-18
G586UR96105540Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-18
00860001161618GreenEggEndoglow, LLCEXX2023-07-07
00840306808258Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2022-11-14
00840306808326Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2022-11-14
00842331181887Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-14
00842331185564Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-14
00842331152450Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-12
00842331155468Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-12
00842331131493Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-10
00842331133619Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-10
00842331135583Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-10