FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653065417
Brand
AESCULAP
Company
Aesculap AG
Model
FF275R
Catalog number
FF275R
Device description
EAR SPECULUM HOLDER
Published
2020-04-20
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
KAGHOLDER, SPECULUM, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAGHolder, Speculum, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653065417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653065417040386530654174038653065417

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining ear speculumA hand-held manual instrument which typically comprises two arms joined at a pivot point and designed for expanding or stretching the tissue around the ear orifice when inserted and opened. It has a blunt distal tip and is used for examination or surgery, typically during ear/nose/throat (ENT) intervention. It is usually made of stainless steel with a self-retaining or adjustable mechanism and is available in various sizes, shapes and contours. 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
true
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
04250603738084LAZICPeter Lazic GmbHKAG2020-12-22
04250603738718LAZICPeter Lazic GmbHKAG2020-12-22
04250603738725LAZICPeter Lazic GmbHKAG2020-12-22
04250603738732LAZICPeter Lazic GmbHKAG2020-12-22
04250603738749LAZICPeter Lazic GmbHKAG2020-12-22
04250603738756LAZICPeter Lazic GmbHKAG2020-12-22
04250603738763LAZICPeter Lazic GmbHKAG2020-12-22
04250603738770LAZICPeter Lazic GmbHKAG2020-12-22
04250603738787LAZICPeter Lazic GmbHKAG2020-12-22
04250603738794LAZICPeter Lazic GmbHKAG2020-12-22
04250603738800LAZICPeter Lazic GmbHKAG2020-12-22
04250603738817LAZICPeter Lazic GmbHKAG2020-12-22
04250603738824LAZICPeter Lazic GmbHKAG2020-12-22
04250603738831LAZICPeter Lazic GmbHKAG2020-12-22
04250603738848LAZICPeter Lazic GmbHKAG2020-12-22
04250603738855LAZICPeter Lazic GmbHKAG2020-12-22
04250603741688LAZICPeter Lazic GmbHKAG2020-12-22
04250603742036LAZICPeter Lazic GmbHKAG2020-12-22
00614950022342ACEACE SURGICAL SUPPLY CO., INC.KAG2019-10-24
00614950022359ACEACE SURGICAL SUPPLY CO., INC.KAG2019-10-24
00614950022366ACEACE SURGICAL SUPPLY CO., INC.KAG2019-10-24