FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653042913
Brand
AESCULAP
Company
Aesculap AG
Model
FB037R
Catalog number
FB037R
Device description
NABATOFF Olive, diam. 12 mm
Published
2020-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAISTRIPPER, VEIN, REUSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAIStripper, Vein, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653042913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653042913040386530429134038653042913

GMDN Terms#

Term, Definition table
TermDefinition
Common bile duct probeA hand-held manual surgical instrument designed as a slender rod made of flexible metal with a blunt bulbous tip, used for exploring the common bile duct, i.e., the union of the cystic and hepatic ducts. It is used in surgical procedures to explore and/or dilate strictures of the common duct. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
04038653177035AESCULAPOG963ROG963R2016-09-23
04038653242962AESCULAPDF262RDF262R2020-06-17
04038653339563AESCULAPJG901JG9012025-03-22
04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
04038653038251AESCULAPDP512RDP512R2020-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776406523MillenniumAvalign Technologies, Inc.GAI2025-07-22
00190776406530MillenniumAvalign Technologies, Inc.GAI2025-07-22
00190776406547MillenniumAvalign Technologies, Inc.GAI2025-07-22
00190776393328MillenniumAvalign Technologies, Inc.GAI2025-05-06
00190776393762MillenniumAvalign Technologies, Inc.GAI2025-05-06
08403207004444Anmuth Medical InternationalAnmuth Medical International, LLCGAI2024-07-01
08403207004451Anmuth Medical InternationalAnmuth Medical International, LLCGAI2024-07-01
08403207004468Anmuth Medical InternationalAnmuth Medical International, LLCGAI2024-07-01
00840183505974BR Surgical, LLCBR Surgical, LLCGAI2024-06-03
00840183510206BR Surgical, LLCBR Surgical, LLCGAI2024-06-03
00840183510312BR Surgical, LLCBR Surgical, LLCGAI2024-06-03
00840183514204BR Surgical, LLCBR Surgical, LLCGAI2024-06-03
00840183517410BR Surgical, LLCBR Surgical, LLCGAI2024-06-03
G586G91006920Novo SurgicalNOVO SURGICAL, INC.GAI2023-12-18
G586G91006930Novo SurgicalNOVO SURGICAL, INC.GAI2023-12-18
G586G91006940Novo SurgicalNOVO SURGICAL, INC.GAI2023-12-18
00840319753866Hayden MedicalHayden Medical, Inc.GAI2023-12-08
00840319753811Hayden MedicalHayden Medical, Inc.GAI2023-12-06
00840319753828Hayden MedicalHayden Medical, Inc.GAI2023-12-06
00840319753835Hayden MedicalHayden Medical, Inc.GAI2023-12-06
00840319753842Hayden MedicalHayden Medical, Inc.GAI2023-12-06
00840319753859Hayden MedicalHayden Medical, Inc.GAI2023-12-06
00190776334611MILLENNIUMAvalign Technologies, Inc.GAI2023-09-28
00842962109311HNM MEDICALHNM STAINLESS, LLC.GAI2023-04-01
00842962109489HNM MEDICALHNM STAINLESS, LLC.GAI2023-04-01
00842962109496HNM MEDICALHNM STAINLESS, LLC.GAI2023-04-01
00842962109502HNM MEDICALHNM STAINLESS, LLC.GAI2023-04-01
00842331186677Novo Surgical Inc. NOVO SURGICAL, INC.GAI2022-11-14
00842331186684Novo Surgical Inc. NOVO SURGICAL, INC.GAI2022-11-14
00842331186691Novo Surgical Inc. NOVO SURGICAL, INC.GAI2022-11-14