FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653178629
Brand
AESCULAP
Company
Aesculap AG
Model
OL460R
Catalog number
OL460R
Device description
BONE CRUSHER
Published
2020-04-22
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
LRCINSTRUMENT, ENT MANUAL SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653178629PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653178629040386531786294038653178629

GMDN Terms#

Term, Definition table
TermDefinition
Surgical tamp, reusableA hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198506089541ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-13
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00198506089572ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-13
08904461031073OSSEOUS-Ear/Nasal ExtractorEON MEDITECH PRIVATE LIMITEDLRC2026-03-13
08904428798377OSSEOUS-CapsuleEON MEDITECH PRIVATE LIMITEDLRC2026-03-13
00198506088926ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-03
00190776417420MillenniumAvalign Technologies, Inc.LRC2026-02-27
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00198506088865ELMED INCORPORATEDELMED INCORPORATEDLRC2026-02-25
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00190776415778MillenniumAvalign Technologies, Inc.LRC2026-02-04
04059453133779Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-02-02
00198506088346ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-30
04059453133755Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-01-29
09348811102638INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-01-28
00190776415495MillenniumAvalign Technologies, Inc.LRC2026-01-27
00198506088070ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-23
00198506087813ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-16