SRI Healthcare 3006

GUDID 00850057346213

Mayo Stand Cover

Elevate Textiles, Inc.

General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00850057346213
• NIH Device Record Key: b172a9b1-885a-42c3-be0a-f256fd66bd2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SRI Healthcare
• Version Model Number: MSC033069000-4-SV-0MDGN-000
• Catalog Number: 3006
• Company DUNS: 825198484
• Company Name: Elevate Textiles, Inc.
• 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: false
• Manufacturing Date: false
• 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: true

Customer Support Contacts

• Phone: 13366841683
• Email: nathaniel.terry@elevatetextiles.com
• Phone: 13366841683
• Email: nathaniel.terry@elevatetextiles.com
• Phone: 13366841683
• Email: nathaniel.terry@elevatetextiles.com
• Phone: 13366841683
• Email: nathaniel.terry@elevatetextiles.com
• Phone: 13366841683
• Email: nathaniel.terry@elevatetextiles.com
• Phone: 13366841683
• Email: nathaniel.terry@elevatetextiles.com
• Phone: 13366841683
• Email: nathaniel.terry@elevatetextiles.com
• Phone: 13366841683
• Email: nathaniel.terry@elevatetextiles.com
• Phone: 13366841683
• Email: nathaniel.terry@elevatetextiles.com
• Phone: 13366841683
• Email: nathaniel.terry@elevatetextiles.com
• Phone: 13366841683
• Email: nathaniel.terry@elevatetextiles.com
• Phone: 13366841683
• Email: nathaniel.terry@elevatetextiles.com
• Phone: 13366841683
• Email: nathaniel.terry@elevatetextiles.com
• Phone: 13366841683
• Email: nathaniel.terry@elevatetextiles.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850057346213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080796

FDA Product Code

• KKX: Drape, Surgical

Sterilization

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

[00850057346213]

Moist Heat or Steam Sterilization

[00850057346213]

Moist Heat or Steam Sterilization

[00850057346213]

Moist Heat or Steam Sterilization

[00850057346213]

Moist Heat or Steam Sterilization

[00850057346213]

Moist Heat or Steam Sterilization

[00850057346213]

Moist Heat or Steam Sterilization

[00850057346213]

Moist Heat or Steam Sterilization

[00850057346213]

Moist Heat or Steam Sterilization

[00850057346213]

Moist Heat or Steam Sterilization

[00850057346213]

Moist Heat or Steam Sterilization

[00850057346213]

Moist Heat or Steam Sterilization

[00850057346213]

Moist Heat or Steam Sterilization

[00850057346213]

Moist Heat or Steam Sterilization

[00850057346213]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-12
• Device Publish Date: 2024-04-04

On-Brand Devices [SRI Healthcare]

• 00850057346329: Surgical Gown, Level 2, Size S, Green, Reuseable
• 00850057346220: Mayo Stand Cover
• 00850057346213: Mayo Stand Cover
• 00850057346206: Mayo Stand Cover
• 00850057346190: BTC070122000-4-SV-0MDGN-000
• 00850057346183: Back Table Cover
• 00850057346176: Back Table Cover
• 00850057346169: Back Table Cover
• 00850057346152: Back Table Cover
• 00850057346138: Sheet, Level 4 large
• 00850057346121: Sheet, Level 4 medium
• 00850057346114: Sheet, Level 4 small
• 00850057346107: Drape, Specialty
• 00850057346084: Drape, three quarter sheet
• 00850057346077: Drape, half sheet
• 00850057346060: Drape, one quarter sheet
• 00850057346008: Mayo Stand Cover
• 00850057346299: Surgical Gown, Level 3, Size L, Green, Reuseable
• 00850057346145: Sheet, Level 4 extra large
• 00850057346091: Drape, Full Sheet
• 00850057346367: Surgical Gown, Level 2, Size 2XL, Green, Reuseable
• 00850057346350: Surgical Gown, Level 2, Size XL, Green, Reuseable
• 00850057346343: Surgical Gown, Level 2, Size LG, Green, Reuseable
• 00850057346336: Surgical Gown, Level 2, Size M, Green, Reuseable
• 00850057346312: Surgical Gown, Level 3, Size 2XL, Green, Reuseable
• 00850057346305: Surgical Gown, Level 3, Size XL, Green, Reuseable
• 00850057346282: Surgical Gown, Level 3, Size M, Green, Reuseable
• 00850057346275: Surgical Gown, Level 4, Size 2XL, Green, Reuseable
• 00850057346268: Surgical Gown, Level 4, Size XL, Green, Reuseable
• 00850057346251: Surgical Gown, Level 4, Size L, Green, Reuseable
• 00850057346244: Surgical Gown, Level 4, Size M, Green, Reuseable
• 00850057346237: Surgical Gown, Level 4, Size S, Green, Reuseable
• 00850057346053: Wrapper, 53 x 72, Size Large, Green
• 00850057346046: Wrapper, 54 x 54, Size 2XL, Green
• 00850057346039: Wrapper, 48 x 48, Size XL, Green
• 00850057346022: Wrapper, 36 x 36, Size Large, Green
• 00850057346015: Surgical Gown, Level 3, Size S, Green, Reuseable