FDA.reportPublic FDA data

AED

Primary DI
00848657084352
Brand
AED
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
8530-06
Device description
AED Kerrison 2mm Cervical Custom
Published
2018-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HAERONGEUR, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023868000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023868000DAN KERRISON RONGEURS, MODELS K1 + BILLY 1Dannoritzer Medical Instruments2003-02-07HAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848657084352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657084352008486570843528486570843520848657084352

GMDN Terms#

Term, Definition table
TermDefinition
Bone punch, reusableA hand-held manual surgical instrument with a cutting/biting action used to cut small cross-sectional pieces of bone typically for biopsy or fixation procedures during a surgical intervention. It is typically designed with a long, thin, two-part sliding shaft (the upper part sliding along the lower part) which is joined to sprung (self-opening), pivoted, pistol grip handles. The working end terminates with a sharp, angled, cutting jaw that closes over an endpiece when the handles are squeezed together cutting through the bone. It is available in various sizes and designs (e.g., it can have upward or downward located jaws) and is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
839138955
Device count
1
Lot or batch
true
Serial number
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848657078450AED5729A2026-07-22
00848657076609AEDU57402026-07-21
00848657076616AEDU57802026-07-21
00848657076623AEDU57902026-07-21
00848657078412AEDAED87035242026-07-21
00848657078429AEDAED87035342026-07-21
00848657078436AEDAED87015342026-07-21
00848657078443AEDAED87025242026-07-21
00848657085656AEDU57852026-07-21
00848657085663AEDU57952026-07-21
00848657078399AEDAED KC-0022026-07-10
00848657078405AEDAED KC-2XL2026-07-10
00848657070683AED17-17192026-06-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776424008MillenniumAvalign Technologies, Inc.HAE2026-08-27
00190776424084MillenniumAvalign Technologies, Inc.HAE2026-08-27
00850003512006SteribiteSteribite, LLCHAE2026-08-27
00850003512044SteribiteSteribite, LLCHAE2026-08-27
00850003512082SteribiteSteribite, LLCHAE2026-08-27
00850003512129SteribiteSteribite, LLCHAE2026-08-27
00850003512167SteribiteSteribite, LLCHAE2026-08-27
00850003512235SteribiteSteribite, LLCHAE2026-08-27
00850003512273SteribiteSteribite, LLCHAE2026-08-27
00850003512310SteribiteSteribite, LLCHAE2026-08-27
00850003512358SteribiteSteribite, LLCHAE2026-08-27
04250325495029VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04250325495036VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04250325495050VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300884VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300891VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300914VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300921VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300938VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300945VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300952VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300969VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300976VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300983VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300990VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968301003VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968301010VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968301027VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968301034VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968301041VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27