FDA.report

AED

Primary DI
00848657021098
Brand
AED
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
32-4430
Device description
AED Dittel Bougies curved without channel 9 CH
Published
2017-08-11
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
EZOUrethrotome

Product Code Classifications

CodeDeviceSpecialtyClass
EZOUrethrotomeGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848657021098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657021098008486570210988486570210980848657021098

GMDN Terms

TermDefinition
UrethrotomeA surgical instrument designed like a long catheter or thin flexible endoscope shape with a lateral moveable small knife at the distal end which is used for incising strictures in the urethra, (the duct by which urine is discharged from the bladder). This operation may be performed either "blind", where the surgeon cannot see the site, or with the help of endoscopic instruments. Some device designs may incorporate an optical channel for endoscopic visual control. 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

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00848657075084AED27174T2026-01-23
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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
04048551232378n.a.Karl Storz GmbH & Co. KGEZO2025-08-11
04048551232781n.a.Karl Storz GmbH & Co. KGEZO2025-08-11
00810143891263Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2024-09-27
00810143890914Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2024-04-15
00850033250756Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2022-06-08
00850033250886Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2022-06-08
00850033250893Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2022-06-08
00850033250909Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2022-06-08
00850033250916Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2022-06-08
00850033250923Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2022-06-08
00190776156718MillenniumAVALIGN TECHNOLOGIES, INC.EZO2020-11-25
00848657076494AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EZO2019-06-14
00848657085083AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EZO2019-06-14
00842331119019Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
00842331119026Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
00842331119033Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
00842331119040Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
00842331119057Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
00842331119064Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
04059082029757Urethrotomy sheathSOPRO-COMEG GmbHEZO2018-03-20
04059082029764ObturatorSOPRO-COMEG GmbHEZO2018-03-20
04059082029771Urethrotomy tubeSOPRO-COMEG GmbHEZO2018-03-20
04059082029788Urethrotomy bridgeSOPRO-COMEG GmbHEZO2018-03-20
04059082029795Urethrotomy knifeSOPRO-COMEG GmbHEZO2018-03-20
04059082029801Urethrotomy knifeSOPRO-COMEG GmbHEZO2018-03-20
04059082029818Urethrotomy sheathSOPRO-COMEG GmbHEZO2018-03-20
04059082029825Urethrotomy knifeSOPRO-COMEG GmbHEZO2018-03-20
04059082029832Urethrotomy knifeSOPRO-COMEG GmbHEZO2018-03-20
04059082029849Urethrotomy knifeSOPRO-COMEG GmbHEZO2018-03-20
04059082029856Urethrotomy sheathSOPRO-COMEG GmbHEZO2018-03-20