FDA.reportPublic FDA data

AESCULAP

Primary DI
04046955074860
Brand
AESCULAP
Company
AESCULAP, INC.
Model
FF815R
Catalog number
FF815R
Device description
"KERRISON Bone Punch conventional, 90 °, downwards cutting, 8"", (205 mm), width: 5 mm, without ejector, thin, non-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

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
04046955074860PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955074860040469550748604046955074860

GMDN Terms#

Term, Definition table
TermDefinition
Bone punch, reusableA hand-held manual surgical instrument with a cutting/biting action used to cut small cross-sectional pieces of bone typically for biopsy or fixation procedures during a surgical intervention. It is typically designed with a long, thin, two-part sliding shaft (the upper part sliding along the lower part) which is joined to sprung (self-opening), pivoted, pistol grip handles. The working end terminates with a sharp, angled, cutting jaw that closes over an endpiece when the handles are squeezed together cutting through the bone. It is available in various sizes and designs (e.g., it can have upward or downward located jaws) and is made of high-grade stainless steel. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964823794AESCULAPMF320MF3202026-04-18
04046964759895VEGAMG985RMG985R2020-10-16
04046964759925VEGAMG982RMG982R2020-10-16
04046964759956VEGAMG981RMG981R2020-10-16
04046964993312AESCULAPMG223RMG223R2026-01-16
04046964993329AESCULAPMG224RMG224R2026-01-16
04046955077069AESCULAPUS137US1372020-08-10
04046955077076AESCULAPUS138US1382020-08-10
04046955066544AESCULAPMG512RMG512R2020-09-26
04046955076550AESCULAPMG065RMG065R2020-09-26
04046955076611AESCULAPMG182RMG182R2020-08-25
04046964759970VEGAMG980RMG980R2020-10-16
04046955919369AESCULAPUS981SUUS981SU2025-10-31
04046955919383AESCULAPUS982SUUS982SU2025-10-31
04046955919406AESCULAPUS983SUUS983SU2025-10-31
04046955920327AESCULAPUS984SUUS984SU2025-10-31
04046955920341AESCULAPUS985SUUS985SU2025-10-31
04046955920365AESCULAPUS986SUUS986SU2025-10-31
04046955920389AESCULAPUS987SUUS987SU2025-10-31
04046955920402AESCULAPUS988SUUS988SU2025-10-31

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G277G2N732330GEN2SURGIX MEDICAL LLCHAE2022-09-28
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