FDA.reportPublic FDA data

Lac-Mac

Primary DI
06277552500294
Brand
Lac-Mac
Company
Lac-Mac Limited
Model
024XGAA
Catalog number
024XGAA
Device description
Lithotomy Drape, Level 4,with 6 X 4 Fenestration
Published
2018-05-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KKXDrape, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031362000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031362000LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALSLac Mac, Ltd.2003-05-30KKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06277552500294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06277552500294062775525002946277552500294

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, reusableA noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height32Inch
Width114Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
201276334
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
08056646500291Basic Implant SetOMNIA SRLKKX2026-03-27
08056646500307Implantology SetOMNIA SRLKKX2026-03-27
08056646500321Oral Surgery SetOMNIA SRLKKX2026-03-27
08056646500482Oral Surgery PackOMNIA SRLKKX2026-03-27
10812564036022MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036077MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036107MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036183MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036190MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036213MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
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20080196017017MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
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