FDA.report

AESCULAP

Primary DI
04038653044290
Brand
AESCULAP
Company
Aesculap AG
Model
FF595R
Catalog number
FF595R
Device description
PAPAVERO-HARTMAN SPREADER F/FF589R-91R
Published
2020-07-06
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
04038653044290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038653044290040386530442904038653044290

GMDN Terms

TermDefinition
Nasal speculum, reusableA hand-held surgical instrument inserted into a nostril and manually expanded to maximally open the nostril by stretching the tissue around the nasal orifice, allowing access for examination or ear/nose/throat (ENT) surgical intervention. The device is made of high-grade stainless steel and has two blunt, contoured blades that are expanded by applying pressure to the pivoted handles. The handles are typically attached to springs so that they close upon release of the pressure applied to them. 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

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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 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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