FDA.reportPublic FDA data

AED

Primary DI
00848657022217
Brand
AED
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
501.06
Device description
Sinus 45 Degree Thru-Cut Punch #501.06
Published
2017-11-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KAYPUNCH, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAYPunch, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848657022217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657022217008486570222178486570222170848657022217

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, non-medicated, reusableA collection of various ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
839138955
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848657078368AEDAED UH8012026-04-23
00848657078276AEDAED 33310UL-R2026-04-13
00848657078283AEDAED 33310UL2026-04-13
00848657078290AEDAED 33321A-R2026-04-13
00848657078306AEDAED 33321A2026-04-13
00848657078313AEDAED 33310FG-R2026-04-13
00848657078320AEDAED 33310FG2026-04-13
00848657078337AEDAED 33310R-R2026-04-13
00848657078344AEDAED 33310R2026-04-13
00848657078351AEDAED 34321SL2026-04-13
00848657078269AEDJZM15922026-03-02
00848657078238AED8830BL2026-02-24
00848657078245AED8830CL2026-02-24
00848657078252AED8830FL2026-02-24
00848657078214AED501.50BS2026-02-18
00848657078221AED501.51BS2026-02-18
00848657023122AEDAED11275FE2026-01-23
00848657023139AEDAED27071TJ2026-01-23
00848657068956AED2717462026-01-23
00848657069236AEDAED27071-92026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840183530693BR Surgical, LLCBR Surgical, LLCKAY2025-08-26
00840183530709BR Surgical, LLCBR Surgical, LLCKAY2025-08-26
00840183530716BR Surgical, LLCBR Surgical, LLCKAY2025-08-26
00840183530723BR Surgical, LLCBR Surgical, LLCKAY2025-08-26
00848657077194AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KAY2025-08-25
00194613081850MSI Precision Specialty InstrumentsMed Saver, Inc.KAY2025-08-01
00757770415847Bausch + LombBausch & Lomb IncorporatedKAY2025-07-31
00757770426256Bausch + LombBausch & Lomb IncorporatedKAY2025-07-31
00757770430840Bausch + LombBausch & Lomb IncorporatedKAY2025-07-31
00757770404667Bausch + LombBausch & Lomb IncorporatedKAY2024-11-20
00757770410842Bausch + LombBausch & Lomb IncorporatedKAY2024-11-20
00757770418541Bausch + LombBausch & Lomb IncorporatedKAY2024-11-20
00757770435531Bausch + LombBausch & Lomb IncorporatedKAY2024-11-20
00757770457748Bausch + LombBausch & Lomb IncorporatedKAY2024-11-19
04049197392938RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197392945RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197392952RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197449083RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197449090RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197449106RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197449113RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197450096RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197450102RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197450188RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197450195RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197450201RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197450232RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197450249RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197450256RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197524728RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16