FDA.reportPublic FDA data

Lac-Mac

Primary DI
00627755831132
Brand
Lac-Mac
Company
Lac-Mac Limited
Model
83MH
Catalog number
83MH
Device description
SMALL DRAPE, 34 x 34, LEVEL 2, ABSORBENT FACING, HEMMED 4 SIDES
Published
2024-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627755831132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627755831132006277558311326277558311320627755831132

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, reusableA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube). This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height34Inch
Width34Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5194322616shelley.petrovskis@lac-mac.com

Regulatory Flags#

DUNS number
201276334
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00627755521002Lac-Mac005XFAH-S005XFAH-S2026-10-13
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
00627755531124Lac-Mac005XFAQ-M005XFAQ-M2024-01-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850067913245SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
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00850067913269SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913276SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913283SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913085SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913092SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913108SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913115SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913122SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913139SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913146SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913153SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913160SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913191SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913214SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913221SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00748426264575Medline-MicrotekMicrotek Medical LLCPUI2026-10-14
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10192253072228CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072235CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072242CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072259CONVERTORSCardinal Health 200, LLCPUI2026-10-14
20193489029946MedlineMEDLINE INDUSTRIES, INC.PUI2026-10-14
20748426264531Medline-MicrotekMicrotek Medical LLCPUI2026-10-14
20748426264593Medline-MicrotekMicrotek Medical LLCPUI2026-10-14
20748426264623Medline-MicrotekMicrotek Medical LLCPUI2026-10-14
20888277636597MedlineMEDLINE INDUSTRIES, INC.PUI2026-10-14
20888277636627MedlineMEDLINE INDUSTRIES, INC.PUI2026-10-14