FDA.report

AED

Primary DI
00848657022262
Brand
AED
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
501.13
Device description
Sinus 45 Degree Blakesley #501.13
Published
2017-11-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KAYPUNCH, NASAL

Product Code Classifications

CodeDeviceSpecialtyClass
KAYPunch, NasalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848657022262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657022262008486570222628486570222620848657022262

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
839138955
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00848657078269AEDJZM15922026-03-02
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00848657078221AED501.51BS2026-02-18
00848657023122AEDAED11275FE2026-01-23
00848657023139AEDAED27071TJ2026-01-23
00848657068956AED2717462026-01-23
00848657069236AEDAED27071-92026-01-23
00848657069243AED67161D2026-01-23
00848657069250AED67161FZ2026-01-23
00848657069618AEDA24136-472026-01-23
00848657074889AED2717452026-01-23
00848657075060AED020-017-2200H2026-01-23
00848657075084AED27174T2026-01-23
00848657075244AED2717432026-01-23
00848657075725AEDAED27425ZG2026-01-23
00848657076289AEDAED27023FG2026-01-23
00848657076692AEDA24131-472026-01-23
00848657078160AEDAED27023ZE2026-01-23
00848657078177AEDAED 27174P2026-01-23
00848657078184AEDA24126-472026-01-23

Other Devices Sharing Product Codes

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
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