Vet Surgical

GUDID 00850031271630

Large, Non-Reinforced Sontara Gown, Spunlace, w. Towel and Wrap

EXACT MEDICAL MANUFACTURING, INC.

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: 00850031271630
• NIH Device Record Key: 81ac8a26-81e2-4e4a-b166-117a04fb002b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vet Surgical
• Version Model Number: 2105
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850031271623 [Primary]
GS1	00850031271630 [Package]; Contains: 00850031271623; Package: Case [60 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120045

FDA Product Code

• FYA: Gown, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-25
• Device Publish Date: 2021-06-17

On-Brand Devices [Vet Surgical]

• 00850031271692: Back Table Cover 50"x90", FF
• 00850031271678: Back Table Cover 44"x 76", FF
• 00850031271654: XL, Non-Reinforced Sontara Gown, Spunlace, w. Towel and Wrap
• 00850031271630: Large, Non-Reinforced Sontara Gown, Spunlace, w. Towel and Wrap
• 26975085709132: Back Table Cover, 50"x90", FF
• 26975085709125: Large, Non-Reinforced Sontara Gown, Spunlace
• 26975085708517: XL, Non-Reinforced Sontara Gown, Spunlace
• 26975424191444: Gown, X-Large, SMS, Non-Reinforced
• 26975424191437: Gown, Large, SMS, Non-Reinforced
• 26975424191390: Mayo Stand Cover 23" x 54"
• 06975085709275: Back Table Cover, 44" x 76", FF