FDA.reportPublic FDA data

Axiom® Lig-A-Boots®

Primary DI
M6653010
Brand
Axiom® Lig-A-Boots®
Company
AXIOM MEDICAL, INCORPORATED
Model
301
Device description
Instrument Jaw Covers, Multi-Color Pack
Published
2018-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDCInstrument, Surgical, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDCInstrument, Surgical, DisposableGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K820161000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K820161000AXIOM LIG-A-BOOTSAxiom Medical, Inc.1982-03-15KDC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M6653011PackageHIBCC5In Commercial Distribution
M6653013PackageHIBCC10In Commercial Distribution
M6653015PackageHIBCC6In Commercial Distribution
M6653010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular booties"A sterile cover, used in pairs, fitted onto the distal working end (the jaws) of artery forceps, vascular clamps, or similar surgical instruments, to provide improved grip for delicate sutures. It is typically tube-like with a closed, rounded tip and composed of radiopaque silicone materials. It is available in various sizes and may be straight or curved. The pair of devices may also be known as ""jaw covers"" (shods). This is a single-use device."

Contacts#

Phone, Email table
PhoneEmail
310-533-9020Sales@AxiomMed.com

Regulatory Flags#

DUNS number
094439676
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M6651000080Axiom®1000082016-09-23
M665100008AT0Axiom® Atraum™ With ClotStop®100008AT2018-09-23
M665100008ATS0Axiom® Atraum™ With ClotStop®100008ATS2018-09-23
M665100008ATSC0Axiom® Atraum™ With ClotStop®100008ATSC2018-09-23
M665100008S0Axiom®100008S2016-09-23
M665100008SC0Axiom®100008SC2016-09-23
M6651000100Axiom®1000102016-09-23
M665100010AT0Axiom® Atraum™ With ClotStop®100010AT2018-09-23
M665100010ATS0Axiom® Atraum™ With ClotStop®100010ATS2018-09-23
M665100010ATSC0Axiom® Atraum™ With ClotStop®100010ATSC2018-09-23
M665100010S0Axiom®100010S2016-09-23
M665100010SC0Axiom®100010SC2016-09-23
M6651000120Axiom®1000122016-09-23
M665100012AT0Axiom® Atraum™ With ClotStop®100012AT2018-09-23
M665100012ATS0Axiom® Atraum™ With ClotStop®100012ATS2018-09-23
M665100012ATSC0Axiom® Atraum™ With ClotStop®100012ATSC2018-09-23
M665100012S0Axiom®100012S2016-09-23
M665100012SC0Axiom®100012SC2016-09-23
M6651000140Axiom®1000142016-09-23
M665100014AT0Axiom® Atraum™ With ClotStop®100014AT2018-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00749756402750DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-22
00749756402767DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-22
00749756402781DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-22
00749756402798DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-22
00749756402910DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-22
B504GS80200VericelProvisionKDC2026-07-20
B504GS80210VericelProvisionKDC2026-07-20
B504GS80220VericelProvisionKDC2026-07-20
00749756402545DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402552DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402569DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402576DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402583DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402590DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402606DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402613DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402620DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402637DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402644DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402651DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402675DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402682DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402712DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402729DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402736DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402743DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402774DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402538DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-06-26