Lac-Mac 075XAAK

GUDID 06277552500362

3000J Mayo Stand Cover

Lac-Mac Limited

Patient surgical drape, reusable

Primary Device ID	06277552500362
NIH Device Record Key	c11534f4-288e-420b-8ada-49f418246d34
Commercial Distribution Status	In Commercial Distribution
Brand Name	Lac-Mac
Version Model Number	075XAAK
Catalog Number	075XAAK
Company DUNS	201276334
Company Name	Lac-Mac Limited
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Width	25 Inch
Height	55 Inch
Width	25 Inch
Height	55 Inch
Width	25 Inch
Height	55 Inch
Width	25 Inch
Height	55 Inch
Width	25 Inch
Height	55 Inch
Width	25 Inch
Height	55 Inch
Width	25 Inch
Height	55 Inch
Width	25 Inch
Height	55 Inch
Width	25 Inch
Height	55 Inch
Width	25 Inch
Height	55 Inch
Width	25 Inch
Height	55 Inch
Width	25 Inch
Height	55 Inch
Width	25 Inch
Height	55 Inch
Width	25 Inch
Height	55 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	06277552500362 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K031362

FDA Product Code

KKX	Drape, Surgical

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[06277552500362]

Moist Heat or Steam Sterilization

[06277552500362]

Moist Heat or Steam Sterilization

[06277552500362]

Moist Heat or Steam Sterilization

[06277552500362]

Moist Heat or Steam Sterilization

[06277552500362]

Moist Heat or Steam Sterilization

[06277552500362]

Moist Heat or Steam Sterilization

[06277552500362]

Moist Heat or Steam Sterilization

[06277552500362]

Moist Heat or Steam Sterilization

[06277552500362]

Moist Heat or Steam Sterilization

[06277552500362]

Moist Heat or Steam Sterilization

[06277552500362]

Moist Heat or Steam Sterilization

[06277552500362]

Moist Heat or Steam Sterilization

[06277552500362]

Moist Heat or Steam Sterilization

[06277552500362]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-11-08
Device Publish Date	2018-10-05

On-Brand Devices [Lac-Mac]

06277558400239	Wrapper ,54 X 72, Level 2, Blue Bias Single Ply
06277558400222	Wrapper, 54 X 54, Level 2, merrow edged blue thread, two ply
06277558400215	Wrapper, 45 X 45, Level 2, merrow edged white thread, two ply
06277558400208	Wrapper, 36 X 36, Level 2, merrow edged light blue thread, two ply
06277558400192	Wrap, 72 X 60, Level 2, yellow bias, single ply
06277558400185	Wrap, 54 X 54, Level 2, red bias, single ply
06277558400178	Wrap, 45 X 45, Level 2, mint green bias, single ply
06277558400161	Wrap, 20 X 20, Level 2, merrow edged white thread
06277558400154	Wrap, 65 X 65, Level 2, merrow edged yellow thread
06277558400147	Wrap, 54 X 54, Level 2, merrow edged blue thread
06277558400130	Wrap, 45 X 45, Level 2, merrow edged white thread
06277558400123	Wrap, 70 X 60, Level 2, merrow edged yellow thread
06277558400116	Wrap, 15 X 15, Level 2, merrow edged blue thread
06277558400109	Wrap, 24 X 24, Level 2, merrow edged mint thread
06277558400093	Wrap, 80 X 60, Level 2, merrow edged black thread
06277558400086	Wrap, 18 X 18, Level 2, Merrow edged blue thread
06277558400079	Wrap, 30 X 30, Level 2, merrow edged pink thread
06277558400062	Wrap, 54 X 54, Level 2, merrow edged red thread
06277558400055	Wrap, 45 X 45, Level 2, merrow edged mint thread
06277558400048	Wrap, 36 X 36, Level 2, merrow edged light blue thread
06277558400031	Wrap, 30 X 30, Level 2, merrow edged yellow thread
06277558400024	Wrap, 23 X 23, Level 2, merrow edged grey thread
06277558400017	Wrap, 18 X 18, Level 2, merrow edged white thread
06277558400000	Wrap, 81 X 60, Level 2, single ply
06277552500362	3000J Mayo Stand Cover
06277552500355	3020K Back Table Cover
06277552500348	Head Drape
06277552500331	Foot Drape
06277552500324	Side Drape
06277552500317	Cysto Stirrup Legging, with red bias on top
06277552500300	Under Buttocks Drape 44 X 44, Level 4
06277552500294	Lithotomy Drape, Level 4,with 6 X 4 Fenestration
06277552500287	Cystoscopy Drape Level 4
06277552500270	Laparoscopic/Cholecystectomy Drape
06277552500263	Caesarian Drape
06277552500256	Child Laparotomy Drape, 100 X 72, Level 4
06277552500249	Laparotomy Drape, Level 4
06277552500232	Back Table Cover, Level 4, 70 X 60, with 56 X 28 Barrier Section
06277552500225	Mayo Stand Cover, 53 X 27, Level 4, Customer Supplied Barcode in specified location
06277552500218	Extra Large Back Table Cover, 94 X 58, LML Barcode, Barrier 82X27
06277552500201	Cardiac Drape 140 X 90, Level 4
06277552500195	Large Mayo Stand Cover ,62X27,Level 4,Yellow Bias at top
06277552500188	Ring Stand Cover, 51 X 51, LevelL4, Barrier 27X27
06277552500171	Extra Large Table Cover, 94 X 58, with customer supplied barcode, barrier 82 X 27
06277552500164	Large Split Drape, 110 X 80, Level 4
06277552500157	Small Split Drape, 86 X 68, Level 4
06277552500140	Medium Sheet, 80 X 60, Mint Bias One End Only
06277552500133	Mayo Stand Cover, 54 X 28, Level 4
06277552500126	Mayo Stand Cover, 53 X 27, Level 4
06277552500119	Mayo Stand Cover, Rounded Bottom, Level 4

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