FDA.reportPublic FDA data

AESCULAP

Primary DI
04046955741458
Brand
AESCULAP
Company
AESCULAP, INC.
Model
FK984NB
Catalog number
FK984NB
Device description
SQ KERRISON 15X5MM 130DG UP STD 200MM
Published
2025-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04046955741458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955741458040469557414584046955741458

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046955074525AESCULAPBH189RBH189R2020-05-08
04046955075249AESCULAPMB180RMB180R2020-05-08
04046955075409AESCULAPMB272RMB272R2020-05-08
04046955075836AESCULAPMB609RMB609R2020-05-08
04046955075935AESCULAPMB749RMB749R2020-05-08
04046955075942AESCULAPMB753RMB753R2020-05-08
04046955075959AESCULAPMB754RMB754R2020-05-08
04046955076017AESCULAPMB770RMB770R2020-05-08
04046955076024AESCULAPMB771RMB771R2020-05-08
04046955076130AESCULAPMB807RMB807R2020-05-08
04046955076147AESCULAPMB808RMB808R2020-05-08
04046955076277AESCULAPMB899RMB899R2020-05-08
04046955075256AESCULAPMB181RMB181R2020-05-07
04046955075966AESCULAPMB757RMB757R2020-05-07
04046955076109AESCULAPMB797RMB797R2020-05-07
04046955076253AESCULAPMB897RMB897R2020-05-07
04046955076260AESCULAPMB898RMB898R2020-05-07
04038653411818AESCULAPMB273RMB273R2020-04-23
04046955074532AESCULAPBH233RBH233R2020-04-23
04046955076543AESCULAPMG061RMG061R2020-09-26

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Primary DI, Brand, Company table
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B235MDK00020mild Device KitSTRYKER CORPORATIONHAE2024-06-19
G277G2N732330GEN2SURGIX MEDICAL LLCHAE2022-09-28
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