POSS E313101

GUDID 10850337007190

Drape, Extremity 89" x 128", SMS, Sterile

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

• Primary Device ID: 10850337007190
• NIH Device Record Key: 2524cc87-15f3-4766-86d0-225fdca09b3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POSS
• Version Model Number: E313101
• Catalog Number: E313101
• 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	00850337007193 [Primary]
GS1	10850337007190 [Package]; Contains: 00850337007193; Package: CASE [18 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101598

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: 2020-03-13
• Device Publish Date: 2020-03-05

On-Brand Devices [POSS]

• 00850337007285: Gown, Surgical, AAMI Level 4, Large, without Pleats
• 10850337007190: Drape, Extremity 89" x 128", SMS, Sterile
• 10850337007077: Gown, Surgical, AAMI level 4, Sterile, X-Large, with Pleat
• 00850337007346: Gown, Surgical Haloguard AAMI Level 4 XX-Large w/ Towel
• 10850337007312: Gown, Surgical Haloguard AAMI Level 4 X-Large w/ Towel
• 00850337007292: Gown, Surgical Haloguard AAMI Level 4 Large w/ Towel
• 00850337007483: Bilateral Limb T-Drape w/ Armboard Covers
• 00850337007469: C-Arm Drape 41" x 74"
• 00850337007445: Mini C-Arm Cover
• 00850337007421: Gown, Surgical, Reinforced AAMI Level 4 XX-Large w/ Towel
• 00850337007407: Ophthalmic Incise Drape w. Pouch 48"x51"
• 00850337007384: Incise Drape 36"x17.5" (Incise 23"x17.5")
• 00850337007360: Poly U-Drape 48"x52" - U Fenestration 6"x19"
• 00850337007520: Sterile Utility Drape W/ Tape 20" x 30"
• 00850337007506: Universal Light Handle Cover