FDA.report

AESCULAP

Primary DI
04038653050871
Brand
AESCULAP
Company
Aesculap AG
Model
OF152
Catalog number
OF152
Device description
SHEA EAR SPECULUM 4.0X5.5MM
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

Related Records

Contact Domains

Product Codes

CodeName
EPYSPECULUM, ENT

Product Code Classifications

CodeDeviceSpecialtyClass
EPYSpeculum, EntGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038653050871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038653050871040386530508714038653050871

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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 DIBrandModelCatalogPublished
04038653177035AESCULAPOG963ROG963R2016-09-23
04038653242962AESCULAPDF262RDF262R2020-06-17
04038653339563AESCULAPJG901JG9012025-03-22
04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
04038653038251AESCULAPDP512RDP512R2020-06-17
04038653038282AESCULAPDP540RDP540R2020-06-17
04038653038299AESCULAPDP541RDP541R2020-06-17
04038653038305AESCULAPDP542RDP542R2020-06-17
04038653177011AESCULAPOG961ROG961R2016-09-23
04038653251407AESCULAPOG960ROG960R2016-09-23
04038653044207MIASPAS MINI-ALIFFF569RFF569R2020-06-17
04038653044214MIASPAS MINI-ALIFFF571RFF571R2020-06-17
04038653044252MIASPAS MINI-ALIFFF578RFF578R2020-06-17
04038653044283MIASPAS MINI-ALIFFF586RFF586R2020-06-17
04038653117307AESCULAPNH196NH1962017-01-27
04038653117352AESCULAPNH206NH2062017-01-27
04038653118540AESCULAPNK088NK0882015-11-11
04038653118557AESCULAPNK089NK0892015-09-24
04038653118564AESCULAPNK090NK0902015-09-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840329837457N/ABLACK & BLACK SURGICAL, INC.EPY2026-03-05
G04360200G0GEIZBear-Ent, LLCEPY2026-03-05
G04360201G0GEIZBear-Ent, LLCEPY2026-03-05
G04360202G0GEIZBear-Ent, LLCEPY2026-03-05
G04360203G0GEIZBear-Ent, LLCEPY2026-03-05
G04360204G0GEIZBear-Ent, LLCEPY2026-03-05
00840329837464N/ABLACK & BLACK SURGICAL, INC.EPY2026-03-04
00198506088414ELMED INCORPORATEDELMED INCORPORATEDEPY2026-02-23
00810158218925PRINCETONPrinceton Medical Group, Inc.EPY2026-02-16
00190776415846MillenniumAvalign Technologies, Inc.EPY2026-02-04
G383WM7778700SURJEXSURJEXEPY2026-01-31
G383WM7778701SURJEXSURJEXEPY2026-01-31
G383WM7778702SURJEXSURJEXEPY2026-01-31
G383WM7778703SURJEXSURJEXEPY2026-01-31
04050659354647Brünings anastignatic aural magnifierSpiggle & Theis Medizintechnik GmbHEPY2026-01-21
00810158218437PRINCETONPrinceton Medical Group, Inc.EPY2026-01-07
00810158218444PRINCETONPrinceton Medical Group, Inc.EPY2026-01-07
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