FDA.reportPublic FDA data

AESCULAP

Primary DI
04046963365615
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MD615
Catalog number
MD615
Device description
"ADSON Bone Rongeur, straight, 8"" (200 mm)"
Published
2020-06-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTXRONGEUR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963365615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963365615040469633656154046963365615

GMDN Terms#

Term, Definition table
TermDefinition
Bone-coring punch, reusableA hand-held manual surgical instrument designed to cut out (core) sections of bone during surgery. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when pressed into the bone and gently rotated will penetrate and cut through the bone allowing that section to be removed. It is and is available in various cutting head sizes, and is not primarily intended for soft-tissue coring. 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810168190396NAPACIFIC INSTRUMENTS, INC.HTX2026-06-26
00198506091216ELMED INCORPORATEDELMED INCORPORATEDHTX2026-06-03
00846338005719ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005726ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005757ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005764ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005771ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005788ForcepsELLIQUENCE, LLCHTX2026-06-02
00810189451490Surgical DesignSurgical Design, Inc.HTX2026-05-29
09348811172174INKAThe Trustee for KAISER FAMILY TRUSTHTX2025-11-21
G586NS5235002SPFB10Novo SurgicalNOVO SURGICAL, INC.HTX2025-02-06
B382SD9238331020Surgical DirectSurgical Direct, Inc.HTX2024-06-25
G586NS20266610Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS20286510Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS20286810Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS34214310Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G45333CC96MM900PEAK MEDPeak Medical Distribution Inc.HTX2023-03-07
B382SD921220120Surgical DirectSurgical Direct, Inc.HTX2022-12-01
07640178988750JULIET ® INSTRUMENTATIONSpineArt SAHTX2019-01-15
07640178988767JULIET ® INSTRUMENTATIONSpineArt SAHTX2019-01-15
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07640185340817SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
07640185340824SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
00192896078819FERRIS-SMITH KERRISONSONTEC INSTRUMENTS, INC.HTX2018-09-20
10381780194521Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTX2018-04-02
10381780194538Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTX2018-04-02
10381780194545Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTX2018-04-02