FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653264186
Brand
AESCULAP
Company
Aesculap AG
Model
EB171R
Catalog number
EB171R
Device description
"LUER-KOERTE Gallstone Scoop, 12 3/4"", (325 mm), malleable, Fig. 1, width: 5,500 mm, non-sterile, reusable"
Published
2020-04-23
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
FHLSCOOP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHLScoopGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653264186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653264186040386532641864038653264186

GMDN Terms#

Term, Definition table
TermDefinition
Stone/foreign-body extraction setA collection of surgical instruments intended to remove calculi, debris, and/or to retrieve fragments of catheter tubing, wire guides, pull wires, plastic stents and other foreign bodies during urological and/or gastroenterological interventions. It typically consists of a retrieval basket and/or grasping forceps, an introducing sheath or sleeve, and possibly a guidewire; the exact design of the set will vary depending on the surgical method. 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
04046963929435NOVOCARTFR719RFR719R2020-08-24
04046963933357NOVOCARTFR651RFR651R2020-08-24
04038653289509NOVOCARTFR661RFR661R2020-08-10
04046963565992NOVOCARTFR660SUFR660SU2020-04-24
04046963939588NOVOCARTFR744RFR744R2020-04-24
04038653201563NOVOCARTFR686RFR686R2020-04-23
04038653403912NOVOCARTFR721RFR721R2020-04-23
04038653403929NOVOCARTFR722RFR722R2020-04-23
04038653403936NOVOCARTFR723RFR723R2020-04-23
04038653403943NOVOCARTFR724RFR724R2020-04-23
04038653403950NOVOCART 3DFR725RFR725R2020-04-23
04038653403967NOVOCARTFR726RFR726R2020-04-23
04038653403974NOVOCARTFR727RFR727R2020-04-23
04038653422357NOVOCARTFR730RFR730R2020-04-23
04038653422388NOVOCARTFR731RFR731R2020-04-23
04046963315498NOVOCARTFR737RFR737R2020-04-23
04046963315504NOVOCARTFR738RFR738R2020-04-23
04046963315511NOVOCARTFR739RFR739R2020-04-23
04046963315528NOVOCARTFR740RFR740R2020-04-23
04038653201556NOVOCARTFR685RFR685R2020-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049047109723GimmiGimmi GmbHFHL2025-05-27
04049047109747GimmiGimmi GmbHFHL2025-05-27
04049047109778GimmiGimmi GmbHFHL2025-05-27
04049047109785GimmiGimmi GmbHFHL2025-05-27
04049047109792GimmiGimmi GmbHFHL2025-05-27
04049047109808GimmiGimmi GmbHFHL2025-05-27
08403207009654Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
08403207009661Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
08403207009678Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
08403207009685Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
00887482173695Symmetry FergusonASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174708Symmetry FergusonASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174715Symmetry FergusonASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174777Symmetry DesjardinsASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174784Symmetry DesjardinsASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174791Symmetry DesjardinsASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174807Symmetry DesjardinsASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00840343721763GEN2SURGIX MEDICAL LLCFHL2024-04-05
00810158210158PRINCETONPrinceton Medical Group, Inc.FHL2024-03-05
G586UR96223150Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
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00842331174582Novo Surgical Inc. NOVO SURGICAL, INC.FHL2022-11-14
00842331174599Novo Surgical Inc. NOVO SURGICAL, INC.FHL2022-11-14
00842331178900Novo Surgical Inc. NOVO SURGICAL, INC.FHL2022-11-14