FDA.reportPublic FDA data

Tapered Delicot

Primary DI
10749915002828
Brand
Tapered Delicot
Company
AMERICAN SURGICAL COMPANY, LLC
Model
63-12T
Device description
Tapered Delicot 8 mm x 19 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
Rx
false
OTC
false
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
00749915002838PrimaryGS10
10749915002828Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00749915002838007499150028387499150028380749915002838
1074991500282810749915002828

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
151054954
Device count
20
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00749915002807Tapered Delicot63-11T2021-06-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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