FDA.reportPublic FDA data

AESCULAP

Primary DI
04046955074723
Brand
AESCULAP
Company
AESCULAP, INC.
Model
FF087R
Catalog number
FF087R
Device description
KERRISON Bone Punch conventional, 90 °, upwards cutting, 8", (205 mm), width: 4 mm, opening width: 15 mm, without ejector, standardnon-sterile, reusable
Published
2019-04-30
Public version status
Update
Distribution status
Not 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
HAERONGEUR, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955074723PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955074723040469550747234046955074723

GMDN Terms#

Term, Definition table
TermDefinition
Bone-coring punch, reusableA hand-held manual surgical instrument designed to cut out (core) sections of bone, or a combination of bone and soft-tissue, during surgery. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when cored into the bone and gently rotated will penetrate and cut through the bone allowing that section to be removed. 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
082594540
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
04046955066742AESCULAPMG714RMG714R2020-05-08
04046964683978AESCULAPMG090RMG090R2020-09-21
04046964587368AESCULAPMA456RMA456R2020-05-08
04046964676628AESCULAPUS399US3992016-09-22
04046964256967AESCULAPUS910US9102016-09-22
05055049000608AESCULAPUS905US9052016-09-22
05055049007423AESCULAPUS906US9062016-09-22
04046955074624AESCULAPFF025RFF025R2019-04-30
04046955074631AESCULAPFF026RFF026R2019-04-30
04046955074648AESCULAPFF027RFF027R2019-04-30
04046955074655AESCULAPFF028RFF028R2019-04-30
04046955074662AESCULAPFF029RFF029R2019-04-30
04046955074716AESCULAPFF086RFF086R2019-04-30
04046955074730AESCULAPFF088RFF088R2019-04-30
04046955074792AESCULAPFF136RFF136R2019-04-30
04046955074808AESCULAPFF137RFF137R2019-04-30
04046955074815AESCULAPFF138RFF138R2019-04-30
04046955074822AESCULAPFF690RFF690R2019-04-30
04046955074914AESCULAPFF828RFF828R2019-04-30
04046955074921AESCULAPFF829RFF829R2019-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776424008MillenniumAvalign Technologies, Inc.HAE2026-08-27
00190776424084MillenniumAvalign Technologies, Inc.HAE2026-08-27
00850003512006SteribiteSteribite, LLCHAE2026-08-27
00850003512044SteribiteSteribite, LLCHAE2026-08-27
00850003512082SteribiteSteribite, LLCHAE2026-08-27
00850003512129SteribiteSteribite, LLCHAE2026-08-27
00850003512167SteribiteSteribite, LLCHAE2026-08-27
00850003512235SteribiteSteribite, LLCHAE2026-08-27
00850003512273SteribiteSteribite, LLCHAE2026-08-27
00850003512310SteribiteSteribite, LLCHAE2026-08-27
00850003512358SteribiteSteribite, LLCHAE2026-08-27
04250325495029VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04250325495036VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04250325495050VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
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04255968300990VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968301003VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968301010VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968301027VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968301034VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968301041VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27