FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653014859
Brand
AESCULAP
Company
Aesculap AG
Model
SF812R
Catalog number
SF812R
Device description
Injection Cannula, straight, (107 mm), diam. 0,80 mm, angled, tip length: 17 mm, luer lock, non-sterile, reusable
Published
2020-04-17
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
KAMCANNULA, SINUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAMCannula, SinusGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653014859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653014859040386530148594038653014859

GMDN Terms#

Term, Definition table
TermDefinition
Basic tracheostomy tube, reusableA hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway. It is typically constructed of metal [stainless steel, silver (Ag) and/or silver plated brass] or plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes (however is not custom-made for a specific patient). It is secured in position by a tracheostomy tube holder fastened around the patient's neck. 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
09348811099082INKAThe Trustee for KAISER FAMILY TRUSTKAM2025-11-28
09348811099099INKAThe Trustee for KAISER FAMILY TRUSTKAM2025-11-28
09348811099112INKAThe Trustee for KAISER FAMILY TRUSTKAM2025-11-28
09348811099129INKAThe Trustee for KAISER FAMILY TRUSTKAM2025-11-28
04250676740618Laryngeal cannulaSpiggle & Theis Medizintechnik GmbHKAM2025-09-12
00757770420797Bausch + LombBausch & Lomb IncorporatedKAM2025-08-15
00757770683505Bausch + LombBausch & Lomb IncorporatedKAM2025-08-05
00194613023133MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
00194613102364MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
00194613102388MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
00194613107444MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
00194613107451MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
00194613108571MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
B3901912038T1Reprocessed 4mm EndoScrub 2 Sheath, 0 deg, w/TubingSURETEK MEDICALKAM2025-05-01
B390197230CVA1Reprocessed 4mm EndoScrub Sheath, 70 deg, K StorzSURETEK MEDICALKAM2025-04-25
00194613065379MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
00194613102371MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
00194613102746MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
00194613108502MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
20080196392275MEDLINEMEDLINE INDUSTRIES, INC.KAM2025-02-14
20888277371771MEDLINEMEDLINE INDUSTRIES, INC.KAM2025-02-14
04250676742360Suction tubeSpiggle & Theis Medizintechnik GmbHKAM2024-12-27
08904461006873OSSEOUS Suction Tube for Sinus-DisposableEON MEDITECH PRIVATE LIMITEDKAM2024-07-03
08904461006880OSSEOUS Suction Tube for Sinus-DisposableEON MEDITECH PRIVATE LIMITEDKAM2024-07-03
04049197306263RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAM2024-06-28
04049197306270RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAM2024-06-28
08906039316452OSSEOUS Suction tubes for Nose ReusableEON MEDITECH PRIVATE LIMITEDKAM2024-06-26
08906039316445OSSEOUS Suction tubes for Nose Reusable EON MEDITECH PRIVATE LIMITEDKAM2024-06-26
08904428747443OSSEOUS Suction tubes for SinusEON MEDITECH PRIVATE LIMITEDKAM2024-06-25
08906039316889OSSEOUS Suction Tubes for Nose DisposableEON MEDITECH PRIVATE LIMITEDKAM2024-06-25