GUDID 10849296007396

WELMED 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

• Primary Device ID: 10849296007396
• NIH Device Record Key: 575dd8e7-8987-42bf-8204-12eaeeb37be0
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1231-173L
• Company DUNS: 828213426
• Company Name: WELMED 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849296007399 [Primary]
GS1	10849296007396 [Package]; Contains: 00849296007399; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070431

FDA Product Code

• FYA: Gown, Surgical

Sterilization

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

[10849296007396]

Ethylene Oxide

[10849296007396]

Ethylene Oxide

[10849296007396]

Ethylene Oxide

[10849296007396]

Ethylene Oxide

[10849296007396]

Ethylene Oxide

[10849296007396]

Ethylene Oxide

[10849296007396]

Ethylene Oxide

[10849296007396]

Ethylene Oxide

[10849296007396]

Ethylene Oxide

[10849296007396]

Ethylene Oxide

[10849296007396]

Ethylene Oxide

[10849296007396]

Ethylene Oxide

[10849296007396]

Ethylene Oxide

[10849296007396]

Ethylene Oxide

[10849296007396]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-08-21

Devices Manufactured by WELMED INC.

• 00849296000574 - NA: 2019-10-23
• 00849296005258 - NA: 2019-10-23
• 10849296007396 - NA: 2019-10-23
• 10849296007396 - NA: 2019-10-23
• 00849296000017 - NA: 2018-11-08
• 10849296000090 - NA: 2018-11-08
• 10849296000106 - NA: 2018-11-08
• 10849296000113 - NA: 2018-11-08
• 10849296000663 - NA: 2018-11-08