Post-Op Sponges

GUDID 00616784334806

Post-Op Sponges, Non-Woven, Sterile, 4" x 3", 4-Ply (10.2cm x 7.6cm)

DYNAREX CORPORATION

General-purpose surgical sponge

• Primary Device ID: 00616784334806
• NIH Device Record Key: 19df5ee6-d1c4-4509-ad80-3b82b02c00a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Post-Op Sponges
• Version Model Number: 3348
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784334806 [Primary]
GS1	00616784334813 [Package]; Package: Pouch [2 Units]; In Commercial Distribution
GS1	00616784334820 [Package]; Contains: 00616784334813; Package: Box [25 Units]; In Commercial Distribution
GS1	00616784334837 [Package]; Contains: 00616784334820; Package: Case [24 Units]; In Commercial Distribution

FDA Product Code

• NAB: Gauze / Sponge,Nonresorbable For External Use

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: 2022-05-06
• Device Publish Date: 2022-04-28

On-Brand Devices [Post-Op Sponges]

• 00616784334905: Post-Op Sponges, Non-Woven, Sterile, 4" x 4", 4-Ply (10.2cm x 10.2cm)
• 00616784334806: Post-Op Sponges, Non-Woven, Sterile, 4" x 3", 4-Ply (10.2cm x 7.6cm)
• 00840117348905: Post-Op Sponges, Non-Woven, Sterile, 4" x 3", 4-Ply (10.2cm x 7.6cm)