BVI

GUDID 06931918142770

Surgical Gown_Non-Reinforced_W/ one hand towle_S_Non-Sterile_28ea/cs

GRI Medical & Electronic Technology Co., Ltd.

Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use

• Primary Device ID: 06931918142770
• NIH Device Record Key: 8f72700e-28d4-490d-a5f9-5bde627d8ffc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BVI
• Version Model Number: 60300469
• Company DUNS: 679894738
• Company Name: GRI Medical & Electronic Technology Co., Ltd.
• Device Count: 28
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06931918142770 [Unit of Use]
GS1	16931918142777 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102652

FDA Product Code

• FYA: Gown, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-28
• Device Publish Date: 2023-07-20

On-Brand Devices [BVI]

• 06931918199125: Surgical Gown_Film reinforced_XL_Non-Sterile_44ea/cs
• 06931918198456: Surgical Gown_Non-Reinforced_W/ one hand towle_XXL_Non-Sterile_28ea/cs
• 26931918193783: Adhesive Incise Film, 10x20cm_sterile_100EA/CS
• 26931918192632: Medium half body incise drape_wetlaid_1 bag_127 x 140cm_Sterile_30EA/CS
• 06931918191426: Surgical Gown_Non-Reinforced_XXL_Non-Sterile_32ea/cs
• 06931918189188: 3/4 body aperture drape_SMS_2 bags_180 x 160cm_Handi-Bin_Non-sterile_840EA/CS
• 06931918185050: Surgical Gown_Non-Reinforced_Medium_Non-Sterile_40ea/cs
• 06931918184145: Small half body incise drape_SMS_1bag_100 x 127cm_Handi-Bin_Non-sterile_1632EA/CS
• 06931918183810: Drawstring Bag_Plastic_12 x 25 cm_500EA/CS
• 06931918181533: SMS wrap_75cmx75cm_Handi-Bin_Non-sterile_5040EA/CS
• 06931918178328: Gown_Set-In sleeve_Standard_W/ one hand towel_Small_Non-sterile_40ea/cs
• 06931918175723: Back table cover_adhesive patch_140cmX180cm_Handi-Bin_Non-sterile_960ea/cs
• 06931918174047: Surgical Gown_Film reinforced_W/ one hand towle_XL_Non-Sterile_36ea/cs
• 06931918173866: Surgical Gown_Film reinforced_M_Non-Sterile_44ea/cs
• 06931918169241: Gown_Standard_Small_Non-sterile_48ea/cs
• 06931918163409: Surgical Gown_Film reinforced_L_Non-Sterile_44ea/cs
• 06931918160767: Back Table Cover_Plastic_150x180 cm_non sterile_864EA/CS
• 06931918157545: Surgical Gown_Film reinforced_W/ one hand towle_L_Non-Sterile_36ea/cs
• 06931918149120: Back table cover_112cmx112cm_Handi-Bin_Non-sterile_910EA/CS
• 06931918145696: Clear adhesive cover_45cmx50cm_Handi-Bin _Non-sterile_14280EA/CS
• 26931918144099: Medium half body incise drape_SMS_channel bag_127cmx140cm_Sterile_30ea/cs
• 06931918143050: Waste Bag with Tape_Plastic_20x39cm_N/S_500ea/cs
• 06931918142770: Surgical Gown_Non-Reinforced_W/ one hand towle_S_Non-Sterile_28ea/cs
• 06931918137431: Surgical Gown_Non-Reinforced_Small_Non-Sterile_32ea/cs
• 06931918136694: Surgical Gown_Film reinforced_W/ one hand towle_M_Non-Sterile_26ea/cs
• 06931918136021: Drawstring Bag_Plastic_18 x 25 cm_500EA/CS
• 06931918128293: Surgical Gown_Film reinforced_XXL_Non-Sterile_36ea/cs
• 06931918117297: Blue mayo cover_Blue_141cmX59cm_Handi-Bin_Non-sterile_1760EA/CS