FDA.reportPublic FDA data

Tapered Delicot

Primary DI
00749915002807
Brand
Tapered Delicot
Company
AMERICAN SURGICAL COMPANY, LLC
Model
63-11T
Device description
Tapered Delicot 9 mm x 13 mm x 76 mm
Published
2021-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HBANeurosurgical Paddie

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBANeurosurgical PaddieNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K902921000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K902921000RAYON NEUROLOGICAL SPONGEAmerican Silk Sutures, Inc.1990-09-18HBA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00749915002807PrimaryGS10
10749915002811Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00749915002807007499150028077499150028070749915002807
1074991500281110749915002811

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical spongeA sterile absorbent material intended to be used on the brain to remove blood and other fluids during an operation. This is a single-use device.

Regulatory Flags#

DUNS number
151054954
Device count
20
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749915002937Atlas Choice Microsurgery Pattie Collection301-012021-12-09
00749915002944Atlas Choice Cranial Pattie Collection300-012021-12-09
00749915002852Tapered Delicot63-08T2021-08-26
00749915002876Tapered Delicot63-13T2021-08-26
00749915002890Tapered Delicot63-14T2021-08-26
00749915002913Tapered Delicot63-15T2021-08-26
10749915002842Tapered Delicot63-08T2021-08-26
10749915002866Tapered Delicot63-13T2021-08-26
10749915002880Tapered Delicot63-14T2021-08-26
10749915002903Tapered Delicot63-15T2021-08-26
20749915002665Tapered Delicot63-05T2021-06-01
00749915002753Tapered Delicot63-06T2021-06-01
00749915002777Tapered Delicot63-07T2021-06-01
00749915002791Tapered Delicot63-09T2021-06-01
00749915002838Tapered Delicot63-12T2021-06-01
20749915002733Tapered Delicot63-06T2021-06-01
10749915002767Tapered Delicot63-07T2021-06-01
10749915002781Tapered Delicot63-09T2021-06-01
10749915002811Tapered Delicot63-11T2021-06-01
10749915002828Tapered Delicot63-12T2021-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000663292ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
00763000663308ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
00763000663346ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
00763000663353ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
00763000663360ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
00763000663735ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
M731K90019Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90049Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90059Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90069Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90079Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90089Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90099Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90109Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90159Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90169Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90179Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90189Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90199Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90209Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90219Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90229Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90239Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90269Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90279Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90289Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90299Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90509Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90519Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90529Spetzler Neuro PattiesOMT, LLCHBA2025-12-31