FDA.reportPublic FDA data

Lac-Mac

Primary DI
00627755840448
Brand
Lac-Mac
Company
Lac-Mac Limited
Model
084E-HL
Catalog number
084E-HL
Device description
Wrap, 15 X 15, Level 2, merrow edged blue thread
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102864000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K10286400084E SERIES SINGLE PLY WRAPPERLac Mac, Ltd.2011-01-14FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627755840448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627755840448006277558404486277558404480627755840448

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, reusableA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Inch
Width15Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
5194322616glankin@lac-mac.com
5194322616Shelley.Petrovskis@lac-mac.com

Regulatory Flags#

DUNS number
201276334
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00627755841179Lac-Mac Limited084E-JK084E-JK2024-11-11
00627755531162Lac-Mac005DSBK-M005DSBK-M2024-08-22
00627755541161Lac-Mac005DSBK-L005DSBK-L2024-08-22
00627755551160Lac-Mac005DSBK-XL005DSBK-XL2024-08-22
00627755561169Lac-Mac005DSBK-2XL005DSBK-2XL2024-08-22
00627755571168Lac-Mac005DSBK-3XL005DSBK-3XL2024-08-22
00627755531148Lac-Mac005XXBN-M2024-08-21
00627755531155Lac-Mac005XXCE-M005XXCE-M2024-08-21
00627755541147Lac-Mac005XXBN-L005XXBN-L2024-08-21
00627755541154Lac-Mac005XXCE-L005XXCE-L2024-08-21
00627755551146Lac-Mac005XXBN-XL005XXBN-XL2024-08-21
00627755551153Lac-Mac005XXCE-XL005XXCE-XL2024-08-21
00627755561145Lac-Mac005XXBN-2XL005XXBN-2XL2024-08-21
00627755561152Lac-Mac005XXCE-2XL005XXCE-2XL2024-08-21
00627755571144Lac-Mac005XXBN-3XL005XXBN-3XL2024-08-21
00627755571151Lac-Mac005XXCE-3XL005XXCE-3XL2024-08-21
00627755581143Lac-Mac005XXBN-4XL005XXBN-4XL2024-08-21
00627755581150Lac-Mac005XXCE-4XL005XXCE-4XL2024-08-21
00627755831132Lac-Mac83MH83MH2024-07-03
00627755531124Lac-Mac005XFAQ-M005XFAQ-M2024-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810194400766AiraAIRA, LLCFRG2026-08-26
00810194403637AiraAIRA, LLCFRG2026-08-26
00810194403644AiraAIRA, LLCFRG2026-08-26
00810194403651AiraAIRA, LLCFRG2026-08-26
00810194403668AiraAIRA, LLCFRG2026-08-26
00810194403675AiraAIRA, LLCFRG2026-08-26
00810194403699AiraAIRA, LLCFRG2026-08-26
00810194403712AiraAIRA, LLCFRG2026-08-26
00810194403729AiraAIRA, LLCFRG2026-08-26
00810194403736AiraAIRA, LLCFRG2026-08-26
08404535030853Brasseler USAPeter Brasseler Holdings, LLCFRG2026-08-21
10724995233386V. MuellerSteris CorporationFRG2026-08-21
00724995241858V. MuellerSteris CorporationFRG2026-08-18
00724995241865V. MuellerSteris CorporationFRG2026-08-18
00724995241872V. MuellerSteris CorporationFRG2026-08-18
00724995241889V. MuellerSteris CorporationFRG2026-08-18
00840118614245Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614252Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614269Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614276Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614283Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614290Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614306Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
20680651497639HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497646HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497653HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497660HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497677HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497684HalyardO&M HALYARD, INC.FRG2026-07-16
00859464007731Turbett Surgical, Inc.Turbett Surgical IncFRG2026-07-14