FDA.reportPublic FDA data

AESCULAP

Primary DI
04046964586033
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MA282R
Catalog number
MA282R
Device description
"HOUSE Micro Ear Needle, curved, 6 1/2"", (165 mm), semi-sharp, malleable shaft, non-sterile, reusable"
Published
2020-05-08
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
KBRNEEDLE, TONSIL SUTURING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBRNeedle, Tonsil SuturingEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964586033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964586033040469645860334046964586033

GMDN Terms#

Term, Definition table
TermDefinition
Tonsil dissector, reusableA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used during the dissection of the tonsils during ear/nose/throat (ENT) surgery. It can be designed in several configurations, e.g., with a shaft that terminates at the distal end with a rounded, curved or angled tip, or it may be double-ended. The tip may be pointed, flat, sharp or blunt and angled or straight from the shaft and may or may not be serrated. It is made of high-grade stainless steel, available in various shapes and sizes, and may include suction capabilities. 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
04046955066865AESCULAPMG727RMG727R2020-10-19
04046955063413AESCULAPMG680RMG680R2026-06-06
04046964683039AESCULAPMB232MB2322026-06-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613021894MSI Precision Specialty InstrumentsMed Saver, Inc.KBR2025-08-01
00194613046040MSI Precision Specialty InstrumentsMed Saver, Inc.KBR2025-08-01
00194613112448MSI Precision Specialty InstrumentsMed Saver, Inc.KBR2025-08-01
00194613115449MSI Precision Specialty InstrumentsMed Saver, Inc.KBR2025-08-01
00194613109752MSI Precision Specialty InstrumentsMed Saver, Inc.KBR2025-03-21
00190776388744MillenniumAvalign Technologies, Inc.KBR2024-11-14
00887482173800Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-15
00887482046562Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-01
00887482119167Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-01
00887482119174Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-01
00887482123966Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-01
00887482123973Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-01
00840343722203GEN2SURGIX MEDICAL LLCKBR2024-04-23
G586E8306200Novo SurgicalNOVO SURGICAL, INC.KBR2023-12-18
00840343720414GEN2SURGIX MEDICAL LLCKBR2023-12-08
00190776303990MillenniumAvalign Technologies, Inc.KBR2023-11-16
00190776304904MillenniumAvalign Technologies, Inc.KBR2023-11-16
00190776044077AvalignAvalign Technologies, Inc.KBR2023-09-28
00190776290733MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776319625MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776319700MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776319885MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776322281MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776322298MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776373801MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776378264MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00840343716240GEN2SURGIX MEDICAL LLCKBR2023-03-22
00840343715427GEN2SURGIX MEDICAL LLCKBR2022-12-29
14026704804815PILLINGTELEFLEX INCORPORATEDKBR2022-12-08
14026704805010PILLINGTELEFLEX INCORPORATEDKBR2022-12-08