Medical Action Industries

GUDID 30809160004078

Pouch: HSeal 4X8 2000/cs

MEDICAL ACTION INDUSTRIES INC.

Sterilization packaging, single-use

• Primary Device ID: 30809160004078
• NIH Device Record Key: d1e6c3e9-58ce-4c5d-9f3d-ab3a554baae9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medical Action Industries
• Version Model Number: 215-
• Company DUNS: 092364462
• Company Name: MEDICAL ACTION INDUSTRIES 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	10809160004074 [Primary]
GS1	20809160004071 [Package]; Contains: 10809160004074; Package: [250 Units]; In Commercial Distribution
GS1	30809160004078 [Package]; Contains: 20809160004071; Package: [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102158

FDA Product Code

• FRG: Wrap, sterilization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-08-20

On-Brand Devices [Medical Action Industries]

• 20809160232245: 79343
• 50809160001460: 731-B2
• 50809160001453: Ndlctr: Foam Strip/Foam Strip 60/Ct
• 50809160001446: Sponge: Bandage Roll Med Super
• 50809160001347: Ndlctr: Mag/Mag
• 50809160001323: Ndlctr: Foam/Foam 20Ct
• 50809160001316: Ndlctr: Foam/Foam 10Ct 200/cs
• 50809160001293: Ndlctr: Foam/Adhesive 30Ct
• 50809160001286: Ndlctr: Foam/Foam 60Ct
• 50809160001279: Ndlctr: Foam/Mag 30Ct
• 50809160001262: Ndlctr: Foam/Adhesive 40Ct
• 50809160001255: Ndlctr: Foam/Ahesive 20Ct
• 50809160001248: Ndlctr: Foam/Adhesive 10Ct
• 50809160001231: Ndlctr: 80Ct Double Foam
• 50809160001224: Ndlctr: Foam/Mag 40Ct
• 50809160001217: Ndlctr: Foam/Mag 20Ct
• 50809160001200: Ndlctr: Foam/Mag 10Ct
• 50809160001194: Ndlctr: Foam 40Ct
• 50809160001187: Ndlctr: Foam 30Ct
• 50809160001170: Ndlctr: Foam 20Ct
• 50809160001163: Ndlctr: Foam 10Ct
• 50809160001156: Ndlctr: Foam Strip/Adhesive 192/Cs
• 50809160001149: Ndlctr: Mag/Foam Strip 30Ct
• 50809160001132: Ndlctr: Foam Strip 15Ct
• 50809160001125: Ndlctr: Foam Strip/Foam Strip 30Ct
• 50809160001118: Ndlctr: Foam Strip 60Ct
• 50809160001101: Ndlctr: Foam Strip/Adhesive 30CT
• 50809160001095: Ndlctr: Foam Strip/Mag 30Ct
• 50809160001088: Ndlctr: Mag/Foam Strip 15Ct
• 50809160001071: Ndlctr: Mag/Mag 60Ct Wht
• 50809160001064: Ndlctr: Mag/Mag 20Ct Wht
• 50809160001057: Ndlctr: Mag/Adhesive 10/Ct
• 50809160001040: Ndlctr: Mag/Adhesive
• 50809160001033: Ndlctr: Mag/Mag Unnumbered
• 50809160001019: Ndlctr: Mag/Mag 60Ct
• 50809160001002: Ndlctr: Mag Cl Top 30/Ct
• 50809160000999: Ndlctr: Mag/Mag 30Ct
• 50809160000982: Ndlctr: Mag/Mag 20/Ct
• 50809160000975: Ndlctr: Mag/Mag Unnumbered
• 50809160000968: Ndlctr: Mag 10Ct
• 50809160000951: Ndlctr: Mag W/Clear Top
• 50809160000715: Towel: OR Blu Pret 400/cs
• 50809160000623: Towel: OR Wht Pret
• 50809160000616: Towel: OR Grn XR 100/cs
• 50809160000609: Towel: OR Grn Pret
• 50809160000593: Towel: OR Blu XR Pret
• 50809160000586: Towel: OR Blu Pret
• 50809160000579: Towel: OR Blu Pret 100/Cs
• 50809160000272: Sponge: Lap 18X18 W 800/Cs
• 50809160000067: Sponge: Lap 4X18 W Pret 2400/Cs