Zhende SG-WR

GUDID 06971004783319

Surgical Gown With Reinforcement, XL, AAMI PB70 Level 3, 1 piece/bag, 26 pieces/carton

Xuchang Zhengde Environstar Medical Products Co., Ltd.

Surgical gown, single-use

• Primary Device ID: 06971004783319
• NIH Device Record Key: e492441c-d636-420a-9444-d8dcd5b70906
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zhende SG-WR
• Version Model Number: ZD23103K
• Company DUNS: 421272799
• Company Name: Xuchang Zhengde Environstar Medical Products Co., Ltd.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971004783302 [Primary]
GS1	06971004783319 [Package]; Contains: 06971004783302; Package: Carton [26 Units]; In Commercial Distribution

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: 2020-09-09
• Device Publish Date: 2020-09-01

On-Brand Devices [Zhende SG-WR]

• 06971004783265: Surgical Gown With Reinforcement, M, AAMI PB70 Level 3, 1 piece/bag, 28 pieces/carton
• 06971004783333: Surgical Gown With Reinforcement, XXL, AAMI PB70 Level 3, 1 piece/bag, 26 pieces/carton
• 06971004783319: Surgical Gown With Reinforcement, XL, AAMI PB70 Level 3, 1 piece/bag, 26 pieces/carton
• 06971004783296: Surgical Gown With Reinforcement, L, AAMI PB70 Level 3, 1 piece/bag, 28 pieces/carton